Pfizer
Gastrointestinal symptom reports
Female, 40 - 59 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 40 | 2020-12-31 | nausea, abdominal pain, diarrhea |
Sore arm at the site x 3 days. that evening fatigue, myalgias. at 4 am the next morning awoke with a...
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Sore arm at the site x 3 days. that evening fatigue, myalgias. at 4 am the next morning awoke with abdominal pain, nausea, then an episode of liquid stool. These continued throughout the next day until the evening of day 2. By morning of day 3 they were gone
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| 40 | 2021-01-01 | decreased appetite |
Severe headache same day lasting for 36 hrs. Severe fatigue starting next day lasting 24 hrs. Sev...
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Severe headache same day lasting for 36 hrs. Severe fatigue starting next day lasting 24 hrs. Severe headache starting again on day 4 lasting through day 5. Unable to focus, eat because of headache. Sore arm for 24 hrs post vaccine.
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| 40 | 2021-01-03 | difficulty swallowing |
Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as thoug...
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Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as though I was going to pass out. Epi pen was administered when I wasn't able to swallow. Was taken to ER on a stretcher, however they said on the way, I wasn't responding and couldn't open my eyes. Muscles began cramping and loss sensation in limbs. Hands wouldn't open up as they cramped. Blood pressure kept going up and down.
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| 40 | 2021-01-03 | diarrhea | Extreme swelling and erythema at vaccination site, mild pain, multiple episodes of diarrhea. |
| 40 | 2021-01-04 | diarrhea |
12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm...
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12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm low grade fever, 11pm 101.2 fever, body aches, fatigue (2 days). Took Ibuprofen. Fever did not go over 99 after Ibuprofen. 2-3 episodes of diarrhea. Seen by PCP on 12/24 via after hours clinic. Recovered in 4 days.
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| 40 | 2021-01-04 | difficulty swallowing |
About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense...
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About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense of fullness/swelling in my throat. I pulled over and called my husband. I could breathe fine, but the sensation of swelling in my throat was frightening and I felt like I couldnt swallow my saliva. I also had the feeling like I might faint (hot and flushed). This all passed pretty quickly (5 minutes), and I took a benadryl when I got home and rested.
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| 40 | 2021-01-04 | nausea | Headache, nausea, metalic taste, general malaise, low back pain |
| 40 | 2021-01-04 | vomiting |
Patient experienced aching, fever, diarrhea that started 12/30/20. Symptoms continued adding chills ...
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Patient experienced aching, fever, diarrhea that started 12/30/20. Symptoms continued adding chills , body aches, and vomiting over the next several days leading to an Emergency Room visit on 1/4/20.
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| 40 | 2021-01-04 | nausea, vomiting | Severe headache, bilateral ear pressure, intense vomiting, chills, dizziness, fatigue, nausea |
| 40 | 2021-01-05 | vomiting |
Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling d...
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Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling dizzy, light-headed and then had a witnessed syncopal episode with seizure-like activity, vomiting and loss of consciousness. Onset of symptoms were almost immediately following receipt of the vaccine. Patient demonstrated seizure-like activity again while in the ED. Patient received lorazepam 1 mg IV, diphenhydramine 50 mg IV, Lactated Ringers 500 ml IV bolus, NS 1000 ml bolus, potassium bicarbonate 25 mEq. Patient ED visit 0852 until 1404. Patient responded well to treatment and was discharged in stable condition.
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| 40 | 2021-01-05 | nausea |
Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), ...
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Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), symptoms improved after 32 hours. Loss of voice at 42 hours but has since came back.
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| 40 | 2021-01-05 | nausea |
dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; diz...
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dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: ej1685) for the first dose via an unspecified route of administration in the right arm on 29Dec2020 09:00 for covid-19 immunization. Medical history included diabetes, anxiety/depression, obesity and allergies to penicillin (PCN). Concomitant medications included metformin hydrochloride (MEFORMIN), glipizide, insulin glargine (TOUJEO), dulaglutide (TRULICITY), gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3, event onset date reported as 29Dec2020 09:15. The events were reported as non-serious. No treatment was received for the event. The outcome of the events was not recovered.
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| 40 | 2021-01-05 | nausea |
left arm hurting; nauseous; UTI; whole body is hot; This is a spontaneous report from a contactable ...
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left arm hurting; nauseous; UTI; whole body is hot; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the left arm, on 19Dec2020 at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she took the vaccine on 19Dec2020. On an unspecified date, patient stated that she had no side effects only her arm was hurting. She stated that her whole body is hot. Stated that she has no temperature and is a little nauseous. Stated that whererever she lays down at one can feel the heat. She stated that it was Pfizer BioNTech Covid 19 vaccine EUA is concerned. She stated that she went to the ER and they thought it was because she was taking a medication for urinary tract infection (UTI) and that she was having a reaction. She stated that her doctor told her that the second day she would have had side effects to UTI medicine. She stated that the doctor is stating that it is due to the vaccine. She wanted to know if she should go back to the ER. She stated that her doctor told her to call the place where the vaccine was received for them to monitor her. She stated that she went through her job off site and that this was her first shot. She clarified that she received the shot in her left arm and it was hurting. Outcome of the events was unknown. Information on lot/batch number has been requested.
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| 40 | 2021-01-06 | nausea |
After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flash...
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After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flashes and nausea, pain in left hip. Got really sleepy. Had problems with left hip, problem getting out of car very stiff. Couldn't stand on the left leg. Had stinging with every step. Burning sensation in the hip. Right arm started having nagging pain with tingling, took Tylenol. Tried to get out of bed, left hip felt like something was poking with fire. Saw bumps on hip, left back. Upper arm was still having tinge. Took Benadryl. Next morning woke up with lesions on left hip, some ruptured that felt like acid and then form a scab. The right arm started with the lesions. Went to urgent care. Dr. diagnosed patient with shingles. Patient questions the Shingles at her age. Pt was given Valtrex for the shingles.
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| 40 | 2021-01-06 | abdominal discomfort |
GI upset with lower abdominal cramping and pain the two mornings after receiving the vaccine. Worse...
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GI upset with lower abdominal cramping and pain the two mornings after receiving the vaccine. Worse on day 2. Improved with eating.
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| 40 | 2021-01-06 | vomiting, nausea | HEADACHE FEVER CHILLS NAUSEA VOMITING WEAKNESS BODY ACHE |
| 40 | 2021-01-06 | abdominal pain upper | Headache and severe stomach pain lasting 2 days |
| 40 | 2021-01-06 | nausea, vomiting | Headache, chills, body-ache, fever, nausea, vomiting, and weakness. |
| 40 | 2021-01-06 | abdominal discomfort, diarrhea |
I received the vaccine at 0930 am 1/6, about 6 hours later I started feeling extreme fatigue and a s...
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I received the vaccine at 0930 am 1/6, about 6 hours later I started feeling extreme fatigue and a slight sore throat. I left work early at that time. When I got home I couldn't stay awake and fell asleep around 6pm. Then starting having GI distress cramping, pain and diarrhea around 9pm-11pm. At 2 am I woke up with chills and fever, I took a Tylenol around 3-4 m and then broke out if huge sweat, then finally fell asleep. 1/7/21 I mostly have soreness, headache and fatigue now.
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| 40 | 2021-01-06 | diarrhea |
Sedation, Myalgia, Diarrhea, pain and chills also reported Narrative: Employee notes approximately ...
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Sedation, Myalgia, Diarrhea, pain and chills also reported Narrative: Employee notes approximately 48 hours of COVID like symptoms, similar but milder than what they experienced with the infection. Noted extreme fatigue, pain, diarrhea, chills and muscle aches with resolved after approximately 48 hours.
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| 40 | 2021-01-07 | nausea, vomiting |
0920 VAC. ; 0930: AFTER VAC. SHOT- NAUSEA/VOMITING, "FOGGY FEELING"; 0930: VS: BP: 145/90, P:...
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0920 VAC. ; 0930: AFTER VAC. SHOT- NAUSEA/VOMITING, "FOGGY FEELING"; 0930: VS: BP: 145/90, P: 89; T: 98.3 DEG. F; 02 SAT: RA: 97%; 0948: VS: BP: 129/82, P: 85, O2 SAT: 98 %R.A.
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| 40 | 2021-01-07 | diarrhea, decreased appetite, abdominal pain upper, vomiting |
Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is alread...
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Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.
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| 40 | 2021-01-07 | diarrhea |
Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a conta...
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Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at the left arm on 31Dec2020 13:00 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness, diarrhea, sore arm, headache, fatigued, and chills on 01Jan2021. The patient did not received any treatment for the evets. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19 via a blood test in Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks. The patient recovered from the events on an unknown date in Jan2021.
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| 40 | 2021-01-07 | nausea, diarrhea |
Headache started at 1pm and was gone by 7:30pm Very sore arm Then the nausea and diarrhea started a...
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Headache started at 1pm and was gone by 7:30pm Very sore arm Then the nausea and diarrhea started and lasted until 5am Then chills started from 3:00am until 7:00am Then fatigue continued throughout the day- I slept for 15hours
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| 40 | 2021-01-07 | difficulty swallowing, diarrhea |
Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and righ...
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Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and right side facial tingling with difficulty to swallow occurred 45 minutes after receiving the vaccine. Patient took 50 mg of Benadryl after 10 minutes there was improvement and after 30 minutes it completely resolved. She woke up the next morning with HA and diarrhea she took Tylenol and will monitor.
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| 40 | 2021-01-07 | diarrhea, decreased appetite |
Severe body aches, chills, headache, fever, joint pain, back pain, fatigue, brain fog, diarrhea, los...
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Severe body aches, chills, headache, fever, joint pain, back pain, fatigue, brain fog, diarrhea, loss of appetite
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| 40 | 2021-01-07 | nausea | Severe headache about 12 hours , severe nausea 18 hours |
| 40 | 2021-01-07 | nausea |
Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right ...
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Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic
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| 40 | 2021-01-07 | nausea, vomiting |
bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; ...
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bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; intense migraine; nauseous stomach; I have not been this sick; This is a spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2, Lot number: Ek5730, intramuscular on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 24Dec2020 03:00, the patient experienced intense migraine and nauseous stomach. On 24Dec2020 07:00, she started throwing up, chills, legs shaky and her symptoms had lasted from Christmas Eve until 29Dec2020. On 27Dec2020, patient's tongue was burning and two days later she had a bloody tongue. She stated, "I have not been this sick as far as I can remember it was awful. I am a healthy person I get the flu shot and any vaccine/shot necessary and have never been sick like this". Since the vaccination, the patient had been tested for COVID-19. She had a nasal swab and SARS cov 2 RNA for which she had a negative result on 29Dec2020. Stated that the test came back negative so these reactions had to be her body fighting off the vaccine. She stated she is no longer puking, no longer shaky or chills but faithfully at 3 am she woke up and had an intense migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. The outcome of the events "chills", "legs shaky" and "throwing up/puking" was recovered on 29Dec2020. The outcome of the other events was recovering.
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| 40 | 2021-01-07 | nausea |
fatigue, headache, nausea, dizziness, body aches which started on 01/08/2021 at 0730 am, took advil ...
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fatigue, headache, nausea, dizziness, body aches which started on 01/08/2021 at 0730 am, took advil at 230 pm and tylenol at 330 pm on 01/08/2021. Pt. states that she is feeling much better after tylenol.
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| 40 | 2021-01-08 | nausea |
1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pa...
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1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.
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| 40 | 2021-01-08 | nausea | Nausea, headache and arm pain |
| 40 | 2021-01-08 | nausea, vomiting | Shaking chills, nausea/vomiting, headache, palpitations. No symptoms with initial vaccine. |
| 40 | 2021-01-09 | nausea, abdominal pain |
12 hr after injection: headache myalgia, arthralgia, fever, abdominal pain, severe nausea started an...
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12 hr after injection: headache myalgia, arthralgia, fever, abdominal pain, severe nausea started and lasted for 12 more hours. Conservative management at home with oral fluid hydration, acetaminophen and ibuprofen helped improved symptoms. Headache is still present on 1/10 at 0200 am, over 24 hr after injection.
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| 40 | 2021-01-09 | nausea | Fever, chills, body aches, nausea, headache |
| 40 | 2021-01-10 | nausea |
0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started ...
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0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal
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| 40 | 2021-01-10 | vomiting |
Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; conf...
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Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-10 | nausea |
C/o headaches onset 12/26 x4 days; Nausea chills onset 12/30 x 2 days; Body aches onset 1/1/21 x 4 d...
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C/o headaches onset 12/26 x4 days; Nausea chills onset 12/30 x 2 days; Body aches onset 1/1/21 x 4 days. Visited urgent care 1/2/21 - labs done & released w/ return to work 2-5 days.
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| 40 | 2021-01-10 | nausea |
This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient r...
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This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.
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| 40 | 2021-01-10 | abdominal discomfort | Tiredness Gastrointestinal effects |
| 40 | 2021-01-10 | vomiting, nausea |
Vaccine recipient received vaccine on 1/8/2021. At the end of her 15 minute observation had a vasova...
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Vaccine recipient received vaccine on 1/8/2021. At the end of her 15 minute observation had a vasovagal episode with diaphoresis, lightheadedness and dizziness. She was sent to the ED for further observation and had experienced nausea and vomiting. She was given Zofran. She was stable and discharged from the ED.
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| 40 | 2021-01-11 | nausea |
Fever; chills; head ache; severe joint pain; nausea; congestion; severe weakness; This is a spontane...
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Fever; chills; head ache; severe joint pain; nausea; congestion; severe weakness; This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 05Jan2021 07:45AM at a single dose for COVID-19 immunization. The patient's medical history included hypothyroid and ADD (Attention Deficit Hyperactivity Disorder), both from an unknown date and unknown if ongoing. The patient had known allergies to PCN. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Concomitant medications included unspecified/ other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jan2021 09:00 AM, the patient experienced fever, chills head ache, severe joint pain, nausea, congestion, and severe weakness. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. Outcome of the events was unknown. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect. Information about lot/batch number is requested.
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| 40 | 2021-01-11 | nausea, diarrhea, vomiting |
Headache- severe x 4 days High Fever (103) (6 hours post injection begain, lasted 1. 5 days) Myalgia...
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Headache- severe x 4 days High Fever (103) (6 hours post injection begain, lasted 1. 5 days) Myalgia Pain - bone, and muscle Vomiting Nausea Agitation Diarrhea Inflammation, edema, heat firm induration at injection site
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| 40 | 2021-01-11 | diarrhea |
about 12 hours after receiving the 2nd dose of vaccine patient started with Chills, Body Aches, Feve...
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about 12 hours after receiving the 2nd dose of vaccine patient started with Chills, Body Aches, Fever, Headache. Stated that a few hours later she started with diarrhea
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| 40 | 2021-01-11 | nausea |
severe shaking chills; fever; muscle/bone aches; muscle/bone aches; headaches; nausea; significant w...
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severe shaking chills; fever; muscle/bone aches; muscle/bone aches; headaches; nausea; significant weakness; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 40-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via unspecified route on left arm at single dose for COVID-19 immunization on 04Jan2021, 07:45 AM, at 40-year-old. No relevant medical history. No allergies to medications, food, or other products. No concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 04Jan2021, 08:00 PM, 12 hours after vaccine, the patient developed severe shaking chills, fever, muscle/bone aches, headaches, nausea, and significant weakness (this lasted about 8 hours). No treatment was received. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.
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| 40 | 2021-01-12 | nausea | Fever Body aches Headache Chills Shaking Nausea |
| 40 | 2021-01-12 | diarrhea, vomiting |
Following day patient developed fever 103, chills, vomiting, 48 hours after vaccine patient develope...
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Following day patient developed fever 103, chills, vomiting, 48 hours after vaccine patient developed diarrhea which lasted 2 days. She was covid tested 1/9/2021 which was negative.
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| 40 | 2021-01-12 | vomiting, nausea, diarrhea | Nausea, Vomiting, lethargy, pain, loose stools. |
| 40 | 2021-01-12 | nausea |
Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flus...
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Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flushing, nausea, headache, dizziness, near syncope, and bouts of being tachycardia. acetaminophen 1gm q6 hours x 4 doses for 2 days ondansetron 4mg x 1 dose
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| 40 | 2021-01-12 | nausea |
This is a 40 y/o woman with a past history of re-entry supraventricular tachycardia who is s/p ablat...
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This is a 40 y/o woman with a past history of re-entry supraventricular tachycardia who is s/p ablation in October, 2020 who presented to our Emergency Room on 1/12/21 due to the abrupt onset of left sided chest discomfort and diaphoresis. The patient awoke from sleep with this sensation. Chest pain was sharp, unchanged since onset, without ameliorating/exacerbating factor or activity. Participated in physical fitness training on day prior to presentation without unusual exertion or activity. Mild nausea on day of presentation. Obtained COVID-19 vaccine the day prior. No history of adverse reaction to vaccines in past. Normal labs/troponin and patient was sent home. Normal ECG. Following ablation in October, Following ablation in Oct, 2020, the patient reports no return of symptoms.
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| 40 | 2021-01-12 | diarrhea, abdominal discomfort |
about 12 hours out had severe body aches, shaking chills, headache and temp of 100. those symptoms ...
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about 12 hours out had severe body aches, shaking chills, headache and temp of 100. those symptoms resolved 48 hours post injection but had upset stomach and loose stool which persisted. 1st injection just had soreness at site and a mild headache
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| 40 | 2021-01-12 | abdominal pain |
heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that we...
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heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that went down from her neck to her abdomen; pain that went down from her neck to her abdomen; injection pain on left arm.; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1686, expiration date not reported), intramuscular on the left arm on 05Jan2021 at 15:00 to 05Jan2021 15:00 at SINGLE DOSE for Covid-19 vaccine. Medical history included allergies, gallbladder problems, and had a little diarrhea. Concomitant medications included famotidine (PEPCID) for any potential allergic reaction, and diphenhydramine hydrochloride (BENADRYL) for allergies, all are ongoing. On 05Jan2021, the patient experienced left ear pain, left side of tongue is sore, pain that went down from her neck to her abdomen, injection pain on left arm, and on 06Jan2021, heaviness in one/left side of the body. The patient is most concerned with the pain she is experiencing. The patient was calling about Covid vaccine and got her first shot yesterday, on 05Jan2021, around 3pm. The patient stated that they had her stay about 30 minutes to make sure no major side effects. She had gone home and noticed that her tongue on left side was swollen and persisted into the evening and had a little diarrhea. She was experiencing left ear pain and decided to lay down. She stated that when she laid down noticed that she had pain that went down from her neck to abdomen, that when she woke up this morning that she had pressure on left side of her body and everything else had gotten better. She clarified that it was not swollen but sore. She stated that the diarrhea is not related to the Covid vaccine but is because she had gallbladder problems, her gallbladder was taken out before the vaccine. She stated not pressure just heavy and that the arm was regular injection pain. She stated that the shooting pain in ears is continuous like she was getting an ear infection. She stated that the symptoms are all on her left side, she clarified pressure on left side as heaviness. Stated that the allergies were diagnosed way before Covid vaccine. The patient wanted to know if other people have experienced these side effects. She stated that left side of tongue swollen resolved overnight because she did not wake up with it. Later she clarified that her left tongue was sore. Resolved completely. She stated left ear pain started last evening, that it comes and goes. Stated that the pain that went from neck to her abdomen started yesterday evening and stopped yesterday evening. Stated her left arm is sore. Stated it is sore if she touches it and is okay if she is just sitting there. She stated that she took diphenhydramine hydrochloride 25mg in case her tongue was swollen and she was having a reaction. Stated that she took two acetaminophen (TYLENOL) before she went to bed. The outcome of the events of left ear pain and injection pain in left arm was not recovered, while pain that went down from her neck to abdomen recovered on 05Jan2021, heaviness in one side of the body recovered on 06Jan2021, the rest of the events recovered on an unspecified date. The seriousness of left arm injection pain was not provided, reporter assessed other events as non-serious. The causality for the event of injection pain to left arm was related to the suspect drug, causality for other events was unknown.
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| 40 | 2021-01-13 | vomiting |
Currently 32 weeks pregnant, delivery date of March 14,2021. The next morning I had a sore arm that...
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Currently 32 weeks pregnant, delivery date of March 14,2021. The next morning I had a sore arm that lasted 2 days. A couple days of fatigue. I had on episode of vomiting, I believe it was the 12/31 or 1/1/.
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| 40 | 2021-01-13 | vomiting |
Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting....
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Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting. Unable to walk due to pain and weakness for 24 hrs
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| 40 | 2021-01-13 | nausea |
Patient describes gastro problems, body aches and headache, lymph nodes are swollen and slight naus...
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Patient describes gastro problems, body aches and headache, lymph nodes are swollen and slight nausea
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| 40 | 2021-01-13 | nausea, vomiting |
Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/visio...
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Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/vision changes, tachycardia-Medium
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| 40 | 2021-01-13 | vomiting, nausea |
onset 01/12/21 at approximately 1:00pm began with report of aching, muscle aches, feverish feeling w...
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onset 01/12/21 at approximately 1:00pm began with report of aching, muscle aches, feverish feeling with chills. Went home at that time. Later that day around 4:00pm developed worsening fever/chills, body aches, nausea. Temp reported 101.8 oral. 01/12/21 around 6:00pm developed vomiting, muscle weakness, fatigue, joint aches, knee pain. During the night reported night sweats. AM 01/13/21 reported temp of 102.5 and new onset of skin sensitivity with touch to include clothing, water with bathing and continued symptoms of all symtpoms reported above. 01/14/21 continues with muscle weakness, body aches, fatigue, chills without temp, new onset of axillary pain right arm and reported chest tightness that began on 01/13/21. Denies difficultly with breathing, just chest tightness. Symptoms are improving each day, just reports lingering today, 01/14/21.
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| 40 | 2021-01-14 | nausea |
1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/...
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1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response
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| 40 | 2021-01-14 | nausea |
HA, fatigue, pain at the injection site and nausea. Treatment include: Tylenol, hydration and tums ...
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HA, fatigue, pain at the injection site and nausea. Treatment include: Tylenol, hydration and tums the next day. Outcome complete resolution of symptoms on day 3.
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| 40 | 2021-01-14 | nausea |
Headache, Acetaminophen and rest, 24+ hours Nausea, no treatment, 24+ hours Fatigue, rest, 24+ hours...
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Headache, Acetaminophen and rest, 24+ hours Nausea, no treatment, 24+ hours Fatigue, rest, 24+ hours Chills, blanket, intermittent over 24+ hours
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| 40 | 2021-01-14 | abdominal pain upper |
Heart palp. started about hour after inj. BP was up and down. Pulse was very high. Tired, stomach c...
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Heart palp. started about hour after inj. BP was up and down. Pulse was very high. Tired, stomach cramps.
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| 40 | 2021-01-14 | difficulty swallowing |
I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing...
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I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing felt slightly off however, I was not aspirated secretions. My throat felt slightly thick and I had the sensation of wanting to clear my throat. I took a deep breath and I could breath. It started to feel like my throat was getting sore or irritated. I felt slightly warmer. I decided to wait the full 30 minutes. When I went to stand had a moment of dizziness that passed but then I felt lightheadedness for about 2 hours after the injection. My ear felt like it was warm and there was slight pressure there. My throat continued to feel irritated and still feels lightly irritated after 4 days. After about 3 hours it felt like something lifted and I felt better. That night I was really fatigued and tired. Maybe slightly cold. The next day felt fine except for the throat irritation that still persists today. The side where I received the injection my arm, shoulder, and chest area felt affected for two days after receiving injection.
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| 40 | 2021-01-14 | nausea, vomiting |
muscle aches; fever; nausea; Vomiting; This is a spontaneous report from a contactable other healthc...
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muscle aches; fever; nausea; Vomiting; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, intramuscular right arm from 08Jan2021 to 08Jan2021 as single dose for COVID-19 immunisation. Historical vaccine includes first dose of BNT162B2 via intramuscular from 18Dec2020 to 18Dec2020 with lot number: EJ1685 on right arm. Medical history included allergies to sulfa drugs. Concomitant medication included metronidazole. The patient previously took Ciprofloxacin and Codeine and experienced allergies. On Saturday, 09Jan2021 at 07:00 AM, the patient developed fever, muscle aches, nausea, and vomiting. The outcome of the events was recovered on Jan2021. No treatment was given for the events. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-01-14 | nausea |
within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nause...
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within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nausea. within 12 hours i had body aches and chills which resolved. after five days i have still been experiencing migraine headaches
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| 40 | 2021-01-15 | nausea, vomiting |
Started with a headache approx 16 hours after injection. Felt fatigued so went to bed and slept for ...
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Started with a headache approx 16 hours after injection. Felt fatigued so went to bed and slept for a little bit. Woke up to eat around 6pm on 1/13/21 and started to get chills and not feeling well along with the headache and fatigue so decided to lie back down. Woke up 1:30am on 1/14/2021 soaked in sweat and nauseous still having all the other symptoms. Took oral temp and was 101.4 shortly after vomited and started having some body aches and went back to bed. Woke back up 5am on 1/14/2021 fever had broke, still had headache, fatigue, and some chills and went to work, took imitrex to help with headache. 1/15/2021 woke up at 4:30am with slight headache feeling much better and by 1/16/21 most symptoms have subsided or gotten extremely better.
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| 40 | 2021-01-16 | nausea | Dizziness, weakness, injection site pain, tiredness, headache, chills, joint pain, nausea. |
| 40 | 2021-01-16 | nausea |
Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post in...
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Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post injection (12/25/20). Mild to minimal nausea off and on the day after injection. Extreme left arm pain from that injection day through the 4th day post injection (12/27/20). After 2nd dose - bruised arm at injection site. Left arm pain not as severe as 1st injection. Headache more mild.najsea a bit more noticeable off and on. Wheezing and nasally. Muscle aches.
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| 40 | 2021-01-16 | diarrhea, nausea | Nausea, diarrhea 7+ days |
| 40 | 2021-01-17 | nausea |
1/7/2021 - NAUSEA, LEG PAIN, CHILLS, FEVER (100); 1/8/2021 - CHEST TIGHTNESS; VA HOSPITAL ED @3PM. G...
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1/7/2021 - NAUSEA, LEG PAIN, CHILLS, FEVER (100); 1/8/2021 - CHEST TIGHTNESS; VA HOSPITAL ED @3PM. GOT AN EKG, XRAY, BLOOD TEST. FEVER UNTIL 8PM (101 F); BODY ACHES.
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| 40 | 2021-01-17 | vomiting, nausea |
Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint ...
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Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint pain, chills, low grade temperature, diaphoresis, lethargy confusion (day 1 only) headache- symptoms last 4 days with height at 24-48 hours
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| 40 | 2021-01-17 | diarrhea |
Starting the evening January 14th I experienced a high fever of 102.3 which responded to Tylenol how...
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Starting the evening January 14th I experienced a high fever of 102.3 which responded to Tylenol however, was persistent for 48hours; in conjunction I experienced significant body aches, migraines, diarrhea, chills, and fatigue. Fever broke by Sunday morning however continuance of body aches and fatigue lasted through the weekend.
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| 40 | 2021-01-18 | nausea |
I woke up at 2am (about 12 hrs after vaccine) with fever and sweats. Took acetaminophen and went bac...
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I woke up at 2am (about 12 hrs after vaccine) with fever and sweats. Took acetaminophen and went back to bed. Up at 6am feeling very fatigued and exhausted. Fever again. Got a shower but couldn't stand up that long too exhausted, dizzy and naseau. Went back to bed and called in sick to work. Took IBU 800mg. Back to sleep. Up at 9m more Tylenol. This continued all day trying to keep fever down. 48hrs later still taking acetaminophen to manage symptoms (back to work) still feeling tried and low grade fever.
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| 40 | 2021-01-18 | nausea |
Sore throat; Headache/has had an off and on headache since this morning; Nausea; Sore arm/had a sore...
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Sore throat; Headache/has had an off and on headache since this morning; Nausea; Sore arm/had a sore right arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140, expiry date: Mar2021), via an unspecified route of administration on the right arm on 04Jan2021 (between 16:00- 16:15) at a single dose for COVID-19 immunization. Medical history included ongoing Hashimoto's disease about 7-8 years ago. She said she doesn't take medication all the time for the condition. Concomitant medication included azithromycin (Z-PAK), bifidobacterium infantis (ALIGN). Patient had nausea since 06Jan2021. Her sore arm started at around 3:00 AM on 05Jan2021 and lasted only one day. The caller asked if the nausea could be caused by the COVID-19 Vaccine, and if so, should she get the second dose of the COVID-19 vaccine. Reported the nausea is more of an annoyance, and she doesn't feel like she is going to throw up. Her nausea has been persisting since it started on 06Jan2021, but had worsened from 07Jan2021, to 08Jan2021. She said she woke up the morning of 08Jan2021 with a sore throat, and has had an off and on headache since the morning. Outcome of the event sore arm was recovered on 05Jan2021, for the remaining events was not recovered No prior vaccinations within 4 weeks. The reporter considered the event non-serious.
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| 40 | 2021-01-18 | vomiting |
Sore throat; congestion; headache; she will vomit; This is a spontaneous report from a contactable c...
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Sore throat; congestion; headache; she will vomit; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program: Pfizer First Connect. A 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730, exp date: 31Mar2021), via an unspecified route of administration on 19Dec2020 for COVID-19 immunization. Medical history included being COVID positive on 16Nov2020. The patient had no other relevant history. There were no concomitant medications (no other products). She was working at a doctor's office. The patient mentioned she was due to receive the 2nd dose of the vaccine on 09Jan2021 at 9 am but currently has a sore throat, congestion and a headache (onset date: 05Jan2021). Her symptoms worsened. It started as just a headache. With the congestion now when she blows her nose, sometimes she will vomit (onset date: Jan2021). She was asking if it was okay for her to take the vaccine tomorrow and for any recommendations. She was tested for COVID the day of reporting (08Jan2021) but had no results with her; she hasn't received the COVID test result back (unknown). No investigation assessment performed. The outcome of she will vomit was unknown while the other events had not recovered.
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| 40 | 2021-01-18 | decreased appetite |
after first dose developed fever 101, shaking chills, anorexia, malaise, and myalgias. Lasted 2.5 da...
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after first dose developed fever 101, shaking chills, anorexia, malaise, and myalgias. Lasted 2.5 days. Eye pain and pressure
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| 40 | 2021-01-19 | nausea |
Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 08Jan2021; Mi...
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Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 08Jan2021; Mild fever; Nausea; Headache; Pain in the muscles and joints; Pain in the muscles and joints; This is a spontaneous report from a contactable consumer reporting for her sister. A 40-years-old female patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 08Jan2021 at single dose for COVID 19 immunization via an unspecified route of administration from 21Dec2020 to 21Dec2020 at SINGLE DOSE for an unspecified indication . The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 21Dec2020. On 08Jan2021 about 12 hours after the administration of the vaccine, the patient experienced mild fever, nausea, headache, pain in the muscles and joints. The outcome of all the reported events was recovering. The patient received the second dose before the day 21. Information on the lot/batch number has been requested.
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| 40 | 2021-01-19 | nausea |
Employee received the 2nd dose of the COVID-19 vaccine at 2:30 PM on 1/11. The next morning (1/12/21...
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Employee received the 2nd dose of the COVID-19 vaccine at 2:30 PM on 1/11. The next morning (1/12/21), she began to have numbness and tingling in the right arm and right side of face and developed dizziness, headache, nausea, and fatigue. Advised by employee COVID hotline to report to the ED.
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| 40 | 2021-01-19 | diarrhea |
Fever; chills; lightheaded; muscle aches; joint pain; diarrhea; lethargy; This is a spontaneous repo...
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Fever; chills; lightheaded; muscle aches; joint pain; diarrhea; lethargy; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date not reported), intramuscular in the left arm on 08Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: EK5730, expiry date not reported), intramuscular in the left arm on 18Dec2020 12:00 at single dose for COVID-19 immunisation. The patient previously took cefalexin (KEFLEX), clindamycin and codeine and experienced drug allergies. On 09Jan2021 12:00, the patient experienced fever, chills, was lightheaded, muscle aches, joint pain, diarrhea and lethargy. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.
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| 40 | 2021-01-19 | nausea, diarrhea | Rash, swelling, nausea, headache, diarrhea, muscle pain, fever, chills |
| 40 | 2021-01-20 | vomiting |
Arm mildly sore; headache and vomiting after 12 midnight. Headache was positional . Lasted about 3...
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Arm mildly sore; headache and vomiting after 12 midnight. Headache was positional . Lasted about 36 hours. Ibuprofen
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| 40 | 2021-01-20 | nausea |
I woke up at 2:45am with chills, a bad headache, sore arm at test site and nausea. I took extra stre...
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I woke up at 2:45am with chills, a bad headache, sore arm at test site and nausea. I took extra strength Tylenol and went back to sleep. The following day, I continued to have the headache and fatigue. I took Tylenol and/or Advil all day to keep the headache at bay and also needed a nap. Today, I feel much better.
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| 40 | 2021-01-20 | retching, retching, retching |
My left arm was sore with any movement for almost 48 hours. The afternoon after my vaccine I didn't...
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My left arm was sore with any movement for almost 48 hours. The afternoon after my vaccine I didn't feel great then I developed tachycardia, dry heaves and broke into a cold sweat. The event lasted between 1.5-2 hours.
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| 40 | 2021-01-20 | decreased appetite |
Throbbing pain; tingling fingers in left arm; pain going up the neck of left side; fever; chills; jo...
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Throbbing pain; tingling fingers in left arm; pain going up the neck of left side; fever; chills; joint pain (both shoulders, low back, hips, and knee); loss of appetite; fatigue; weakness; headache; muscle pain; This is a spontaneous report from a contactable Other HCP (patient). This 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 08Jan2021 on Arm left at single dose (Lot # 3249) for covid-19 immunisation. Medical history included Osteoporosis, vitamin D deficient. No known allergies. No other vaccine in four weeks. Concomitant medications included other medications in two weeks. She experienced throbbing pain and tingling fingers in left arm, pain going up the neck of left side. Also experience typical side effects: fever, chills, joint pain (both shoulders, low back, hips, and knee), loss of appetite, fatigue, weakness, headache, and muscle pain on 09Jan2021. No Covid prior vaccination. No covid tested post vaccination. No treatments received. Outcome of the events was recovering.
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| 40 | 2021-01-20 | nausea | Vertigo, dizziness nausea |
| 40 | 2021-01-21 | nausea, abdominal discomfort |
A few minutes after receiving the vaccine I started feeling very dizzy. I then felt nauseous. In abo...
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A few minutes after receiving the vaccine I started feeling very dizzy. I then felt nauseous. In about thirty minutes the dizziness improved but several hours later I still feel residual dizziness and minor problems in GI tract. I slept after returning home, drank water and took Pepcid prescribed to me for my IBS
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| 40 | 2021-01-21 | vomiting, abdominal pain upper, nausea | Body ache headache stiff neck stomach pain nausea vomiting arm swelling |
| 40 | 2021-01-22 | abdominal pain upper |
Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak...
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Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak Lightheadedness Dizzy Loss of balance Tingling in lips Swollen throat
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| 40 | 2021-01-23 | nausea | Body aches, chills fever and nausea |
| 40 | 2021-01-24 | nausea |
Headache and nausea 20 minutes after vaccine given - baseline history of nausea. Resolved after lyin...
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Headache and nausea 20 minutes after vaccine given - baseline history of nausea. Resolved after lying supine and a glass of water.
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| 40 | 2021-01-24 | vomiting |
Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nyst...
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Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.
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| 40 | 2021-01-24 | nausea |
beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea,...
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beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea, feeling warm -- temp of 100.7; chills, fever, and nausea all morning of 1/21/21; fever and chills continued through 1/22/21 around 11am. Treated with Tylenol and Zofran. On 1/22/21 noticed lymph node swelling on arm where vaccine given. Neuropathy 1/22/21. Treated wtih ibuprofen 600mg TID. Lymph node remains swollen as of 1/25/21. Lymph node is hard.
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| 40 | 2021-01-25 | nausea |
1. ALL started around 4:00pm on 1/24/21-Severe muscle aches, fever (100.8), severe headache, chills,...
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1. ALL started around 4:00pm on 1/24/21-Severe muscle aches, fever (100.8), severe headache, chills, sore throat, nausea 2. Noticed rash on 1/15/21-Rash on right side on stomach, side, and around back
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| 40 | 2021-01-25 | nausea | 15 hours post vaccination, I am experiencing headache, nausea, fever, and body aches |
| 40 | 2021-01-25 | nausea |
I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I ...
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I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I developed arm pain at the injection site. Since there were no other side effects in the morning, I returned to work for my regularly scheduled shift on 01/05/2021 at 0545. At approximately 0615 I began to get body aches and restlessness. At approximately 0725 in addition to the body aches and restlessness, I began to get severe nausea, weakness, light-headedness, headache, profuse sweating, and severe chest pain and shortness of breath. Because of the severity of my symptoms my manager immediately told me to go to the ED and a fellow co-worked brought me down via wheelchair. In the emergency department I was assessed and worked up and after several tests and xrays I was given a diagnosis of adverse reaction to drug/vaccine. I was discharged to home at approximately 1130 on 01/05/2021. Upon arriving home I continued to have body aches, and then developed chills, shaking and fever of 101.00. All of this combined became unbearable and I had to take 500mg of Tylenol at 2230 on 01/05/2021. On 01/06/2021 I still felt horrible with body aches, fever, nausea and fatigue. My weakness, fatigue are still present today 01/07/2021 at 0945.
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| 40 | 2021-01-25 | retching, nausea |
On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and starte...
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On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and started having intense, crushing pain in my CTL back (with the worst of it being in my thoracic and lumbar areas). *The nausea and subsequent dry heaving subsided within 6-8 hours with prescribed anti nausea. *The back pain only intensified, with me finally calling my doctor who recommended contacting ONE Parkview. This back pain continues today (1/26/2021). On 1/21/2021, in the early hours of the morning, I woke to hives over my entire trunk, left arm (injection site), and left thigh. *This subsided in maybe 10 or so hours with antihistamines. On 1/23/2021, at approximately 1100, I felt heat in my left arm. This coincided with a heavy feeling in my left arm. When examined, I noted that my upper arm was slightly swollen, blotchy, and had a reddened rash approximately 4x4 inches. Minor itching. *The swelling subsided by 1/25/2021, but the heat and reddened rash continues today (1/26/2021).
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| 40 | 2021-01-25 | diarrhea, abdominal discomfort |
Severe body aches; Chills; Headache; Temp 100; GI upset; diarrhea; This is a spontaneous report from...
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Severe body aches; Chills; Headache; Temp 100; GI upset; diarrhea; This is a spontaneous report from a contactable physician (patient) reported that a 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 11Jan2021 09:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL), ibuprofen and biotin, cyanocobalamin, folic acid (MVI 3). The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 21Dec2020 07:15 on the right arm for COVID-19 immunization. On 11Jan2021 21:30 (reported as 'after 12 hours'), the patient experienced severe body aches, chills, headache and temp 100, then after 48 hours (Jan2021) those symptoms resolved, but had GI upset and diarrhea. The patient underwent lab tests and procedures which included body temperature: 100 (no unit reported) on 11Jan2021. The outcome the events severe body aches, chills, headache and temp 100 was recovered on Jan2021 (reported as after 48 hours those symptoms resolved) while GI upset and diarrhea was recovering. The patient did not received any treatment for the reported events.
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| 40 | 2021-01-25 | nausea |
headache; chills; tiredness; nausea; feeling unwell; This is a spontaneous report received from a co...
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headache; chills; tiredness; nausea; feeling unwell; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 40-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), intramuscular in left arm, on 11Jan2021 00:00 (reported as 12:00AM), at single dose, for COVID-19 immunization, in workplace clinic. There was no medical history. Concomitant medication was not reported. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination. The patient did not receive other vaccines in four weeks. The patient is not pregnant. The patient experienced headache, chills, tiredness, nausea and was feeling unwell all on 11Jan2021 14:30. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The outcome of the events was recovering.
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| 40 | 2021-01-26 | vomiting |
36 hours after the injection I developed large red, warm and painful area at the injection site. 24 ...
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36 hours after the injection I developed large red, warm and painful area at the injection site. 24 hours after that I was experiencing fever and chills again. I also started to vomit
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| 40 | 2021-01-26 | nausea |
Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and sync...
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Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and syncope. Symptoms progressed over time until she seemed almost catatonic at times including delayed responses, staring straight ahead (later she closed her eyes), slurred speech. She kept repeating, "I feel like jelly" and that she was very tired. Pharmacist gave her 25 mg diphenhydramine at 10:55 am. Around 11:10 the facilities administer called 911 at the request of (PharmD).
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| 40 | 2021-01-26 | nausea, vomiting |
Dizziness, fatigue, nausea and vomiting, fever of 102. Felt very weak for 24. Dizziness remained aft...
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Dizziness, fatigue, nausea and vomiting, fever of 102. Felt very weak for 24. Dizziness remained after other symptoms resolved.
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| 40 | 2021-01-26 | nausea | Fatigue, headache, body ache, chills, nausea Started in the morning, faded in the evening |
| 40 | 2021-01-26 | abdominal pain | Following administration of vaccine patient c/o pain on right side of abdomen. Pain 2 on 1/10 scale. |
| 40 | 2021-01-26 | nausea, vomiting |
RECEIVED VACCINE IN THE AM. IN THE EVENING I STARTED TO FEEL FATIGUED AND BEGAN TO HAVE CHILLS. AR...
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RECEIVED VACCINE IN THE AM. IN THE EVENING I STARTED TO FEEL FATIGUED AND BEGAN TO HAVE CHILLS. AROUND 2AM I WOKE UP WITH A FEVER (99F), CHILLS, BODY ACHES, SORENESS IN LEFT ARM AND LEFT SIDE OF NECK, HEADACHE, NAUSEA & VOMITTING. I TOOK 4 X 200MG IBUPROFEN. I FINALLY WAS ABLE TO SLEEP AGAIN AROUND 7AM. I HAD A HEADACHE, BODY ACHES, NAUSEA AND FATIGUE THROUGH THE REST OF THE DAY. I SLEPT MOST OF THE DAY. AFTER 48 HOURS MOST SIDE EFFECTS WERE GONE, EXCEPT FATIGUE AND SORENESS IN LEFT ARM AND SIDE OF NECK.
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| 40 | 2021-01-26 | nausea | fever 102.5 chills sweating body aches nausea fatigue |
| 40 | 2021-01-27 | vomiting, nausea |
Headache; fatigue; chills; nausea; vomiting; fever up to 101.4; sweating; This is a spontaneous repo...
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Headache; fatigue; chills; nausea; vomiting; fever up to 101.4; sweating; This is a spontaneous report from a contactable other hcp. A 40-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported) via an unspecified route of administration on the right arm on 12Jan2021 03:45 at single dose for COVID-19 immunization. Medical history included migraine and acid reflux from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medication included pantoprazole for acid reflux. The patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685, expiry date not reported) on 22Dec2020 on the right arm for COVID-19 immunization. The patient experienced headache, fatigue, chills, nausea, vomiting, fever up to 101.4 and sweating on 13Jan2021 12:00. The patient underwent lab tests and procedures which included body temperature: 101.4 on 13Jan2021. The patient recovered from the events on an unspecified date. No treatment was given in response to the events. The patient had no COVID prior to vaccination and has not COVID tested post vaccination.
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| 40 | 2021-01-27 | diarrhea |
diarrhea that self resolved 18hrs after injection. diarrhea exactly 7 days from injection that also...
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diarrhea that self resolved 18hrs after injection. diarrhea exactly 7 days from injection that also self resolved.
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| 40 | 2021-01-27 | nausea |
employee became light headed, dizzy and nauseous. 10-15 min after vaccine. 0956 vitals were taken a...
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employee became light headed, dizzy and nauseous. 10-15 min after vaccine. 0956 vitals were taken and employee was asked to lay down on cot (vitals 143/83 p 90) 1003 employee began to have seizure like activity a rapid response was called at 1008. Employee refused to go to ED , husband notified. 1020 Benadryl was given per MD continued monitoring until 1135 employee was recommended to go to ED by MD , she refused stated she was ok just tired. Assisted to vehicle with husband at 1140
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| 40 | 2021-01-27 | nausea, vomiting, diarrhea |
weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy;...
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weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient). This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event. No follow up attempts are possible; information about lot/batch number cannot be obtained.
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| 40 | 2021-01-28 | nausea |
Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Too...
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Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Took Tylenol, fluids, Benadryl, and rest.
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| 40 | 2021-01-28 | nausea |
I received 2 dose on 1/26 at 8:40 a.m. About 4:30 p.m. I start feeling a throbbing pain at injectio...
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I received 2 dose on 1/26 at 8:40 a.m. About 4:30 p.m. I start feeling a throbbing pain at injection site. I around home about 6:00 p.m. immediately I start having chills, fever, muscle ache , nausea , and headaches. I could not sleep all night I was back and forth with chills and fever up to 102 for two days. On third day I felt better but headache and nausea linger still.
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| 40 | 2021-01-28 | nausea |
Vaccine taken at 6:30 am. Soreness in left arm started around 8-8:30. Felt tired all day but after a...
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Vaccine taken at 6:30 am. Soreness in left arm started around 8-8:30. Felt tired all day but after a nap around 11:30ish felt nauseous, ate to try and calm it but it got worse throughout the day especially at night around 9pm finally relaxed enough to fall asleep, woke up at 7am feeling more nauseous than yesterday with a bad headache located in the front of my head not throbbed but constant. Laying down just felt really sick so I called my doctor around 9:15am.
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| 40 | 2021-01-28 | vomiting | fever 38.7, vomiting x2, chills, body ache, headache, swelling of left arm for the next three days. |
| 40 | 2021-01-29 | nausea |
Patient c/o slight numbenss at the injection site and to the back side of the arm along with feeling...
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Patient c/o slight numbenss at the injection site and to the back side of the arm along with feelings of queasiness. Ears were flush, no redness noted at the injection site or arm after fifteen minutes. Pt was able to lift her arm and hold it without any difficulty. Pt reported not eating anything this morning before recieving the vaccine. Pt allowed to lie down and monitored for 15 more minutes. Pt verbalized that she felt better after the additional 15 minutes, ears were with in normal color.
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| 40 | 2021-01-31 | difficulty swallowing |
Patient administered 2nd dose of Pfizer COVID vaccine on 1/25/2020. Six days later the patient de...
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Patient administered 2nd dose of Pfizer COVID vaccine on 1/25/2020. Six days later the patient developed generalized hives treated with over the counter antihistamine (benadryl). The next day patient again had hives, trouble swallowing, and difficulty breathing. She presented to an Emergency Department and was treated with epi IM and oral antihistamines (H1 and H2). Discharged to home on prednisone 40 mg PO QD x 3 days and then 20 mg PO QD x 2 days. Patient again had trouble breathing 2/1/2020 and returned to the ED. Patient 10 weeks pregnant.
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| 40 | 2021-01-31 | nausea |
Several hours after getting 2nd dose, left arm very painful. The next morning she woke up and had in...
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Several hours after getting 2nd dose, left arm very painful. The next morning she woke up and had increase in arm pain, not able to move it, body aches, chills, nausea, and fatigue. symptoms remain today.
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| 40 | 2021-02-01 | nausea |
I felt extremely hot/cold sensation in a claustrophobic; I felt extremely hot/cold sensation in a cl...
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I felt extremely hot/cold sensation in a claustrophobic; I felt extremely hot/cold sensation in a claustrophobic; nauseous; Dizzy; headache; fatigue/I'm just exhausted 72 hours later; fever kept rising; I started violently projectile vomiting for a few hours; I got the chills; I was sore; felt "hungover"; the arm soreness; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) on her right arm, intramuscular on 16Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included anxiety, acid reflux and cholecystectomy. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), clonazepam (CLONAPAM) and an unspecified antacid. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 as first dose. It was reported that 12 hours later after vaccination, the patient felt really hot and nauseous, dizzy, headache and fatigue. But then 24 hours later her fever kept rising. She felt extremely hot/cold sensation in a claustrophobic. At peak of her fever, 100F, she started violently projectile vomiting for a few hours. Then she got the chills. Felt nauseous still. But no more vomiting, fever went down on its own. The next day 48 hours later, she was sore and felt "hungover". This time the arm soreness dissipated twice as fast. Now she just exhausted 72 hours later; all events occurred on 17Jan2021 at 02:00. No treatment was received for the events. The outcome of the events was recovered with sequel.
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| 40 | 2021-02-01 | diarrhea, vomiting | Vomiting, diarrhea, fever, generalized intense pain. Fatigue still experiencing at this time |
| 40 | 2021-02-03 | vomiting |
Dizziness; extreme fatigue (unable to drive and doze off during conversations); headache; muscle ach...
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Dizziness; extreme fatigue (unable to drive and doze off during conversations); headache; muscle aches; vomiting still after 8 days.; This is a spontaneous report from a contactable healthcare professional (patient herself). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the right arm on 12Jan2021 09:00 at single dose for COVID-19 immunisation. Medical history included bipolar disorder and ovarian cyst. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included trazodone, desvenlafaxine succinate (PRISTIQ), and oxcarbazepine (TRILEPTAL). The patient previously took morphine sulfate and experienced allergies. On 12Jan2021 19:00, the patient experienced dizziness, extreme fatigue (unable to drive and doze off during conversations), headache, muscle aches and vomiting still after 8 days. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 12Jan2021. No treatment was received for the adverse events. Clinical outcome of the events was not recovered.
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| 40 | 2021-02-03 | nausea |
nausea; severe headache; This is a spontaneous report from a contactable physician (patient). A 40-y...
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nausea; severe headache; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3249, expiration date not reported) via an unspecified route of administration on the left arm on 16Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) and sertraline. On 17Jan2021 05:00 AM, the patient experienced nausea and severe headache. The facility where the vaccine was administered was the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Patient was not pregnant. Therapeutic measures were taken as a result of the events which included naproxen and acetaminophen (TYLENOL). Outcome of the events was not recovered.
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| 40 | 2021-02-04 | nausea |
45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and fe...
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45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and feet, progressing to the knees. Injection site warm, BP 132/96. On exam, oropharynx mild erythema - no edema and no stridor. Lungs CTA. Cor - S1 S2 slightly rapid. Abd soft, non-tender, positive BS. No rashes. Gave Benadryl 50 mg and prednisone 20 mg. BP 110/72. HR 72. O2 Sat 98%. Temp 98.3F.
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| 40 | 2021-02-04 | abdominal distension |
A few days after the vaccination I begin having mild symptoms as if I had COVID so I went and got te...
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A few days after the vaccination I begin having mild symptoms as if I had COVID so I went and got tested on 12/24 and was positive for covid. I was experiencing SOB so I had a virtual Urgent Care and was prescribed a weeks worth of Deckadron and antibiotic and all symptoms cleared up. I also experienced extended abdominal distenstion for an extended period of time.
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| 40 | 2021-02-04 | abdominal pain upper, abdominal pain |
A few hours after taking the vaccine I began having severe abdominal cramps in my upper to mid-abdom...
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A few hours after taking the vaccine I began having severe abdominal cramps in my upper to mid-abdomen. It?s been about 48 hours since the vaccine was administered and the abdominal cramps are still present. Also, when I eat food it hurts my stomach. Since this vaccine is so no I wasn?t sure who to contact. I have been waiting to see if the symptoms will subside. If the problem persists, I will seek medical care. I plan to speak with a doctor regarding the matter on Monday.
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| 40 | 2021-02-04 | abdominal distension |
Shortly after the vaccination I was still having the abdominal distention so I called to see if I co...
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Shortly after the vaccination I was still having the abdominal distention so I called to see if I could defer the 2nd vaccine because I wasnt feeling well and still experiencing AE from the 1st dose. I was advised I still had to get the vaccine so I did and by 2:30pm I begin to have severe facial swelling causing asymmetrical shaping of my face, my head was hurting extremely bad, fatigued and felt really bad. I had to lay down because my head was hurting, felt like I had pressure on the top of my head, neck and back. The pain was so bad I was transported to the ER and was isolated d/t previous COVID infection and all while there the my body felt as if it was steady swelling. I was hurting so bad I couldnt stand to be touched. I was given another round of steroids. I was advised I had COVID pnemonia and was given IM decadron, IM regalin and a subQ injection of immatrex for the headaches and administered ibuprophen and tynenol for the headache as well. I was discharged with a prescription of regalin and decadron. The ER dr. states I shouldnt have taken the 2nd vaccine because I was still suffering from COVID-19. The abdominal distention had dissolved but the congestion just will not clear up even after 3 rounds of steroids. Asoumedrol was prescribed by my ENT but it didnt help either so I have a CT Scan scheduled for next week with my ENT and has not been able to return to work since the 1st dose 12/22. I have be retested for COVID-19 on both 1/15 and 1/25 and both results are still positive for COVID.
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| 40 | 2021-02-04 | abdominal pain upper, diarrhea |
felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was...
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felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was standing and felt dizzy, like she was going to black out; she was standing and felt dizzy, like she was going to black out; heart was racing; pale; sweating/drenched her clothes in sweat; felt so weak she could not get back to my bed; breathing was rapid; stomach pain; diarrhea; patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142), via an unspecified route of administration in the left arm, on 14Jan2021 15:15 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020. Then, it was about 12 hours later (15Jan2021 at 04:00), when she stood up to use the bathroom. She felt like she was running a fever and didn't feel well: she was standing and felt dizzy, like she was going to black out, her heart was racing, and she had to lie down. She was pale and sweating; and felt so weak she could not get back to bed. Patient's husband had to help her. These feelings lasted for about 25 minutes. Patient drenched her clothes in sweat and her breathing was rapid. Then she got stomach pain and diarrhea. The outcome of events was recovered on Jan2021. The patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 40 | 2021-02-07 | difficulty swallowing |
25 minutes after her vaccine, patient's tongue and lips started tingling. She said they were not swo...
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25 minutes after her vaccine, patient's tongue and lips started tingling. She said they were not swollen but she definitely had a tingling feeling. She felt as if she had difficulty swallowing and had some hives on her back. These symptoms all resolved after 3 hours. She never had trouble breathing and was able to eat her dinner.
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| 40 | 2021-02-07 | nausea | 8 DAYS ONGOING, NAUSEA, BODY ACHES, NECK MUSCLE TIGHTNESS, LOW GRADE FEVER, DIAPHRESIS, HEADACHES |
| 40 | 2021-02-07 | vomiting, nausea | Nausea, vomiting, dizziness, chills, body aches, hives on right leg |
| 40 | 2021-02-07 | nausea |
inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were ...
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inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were swollen; both legs were tingly; dizzy; very weak; shaky; This is a spontaneous report from a non-contactable consumer (patient). A 40-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included asthma, mitral valve, Known allergies: Sulfa, Shellfish, sulfide. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR) and Asthma inhalers. 6 hrs after vaccinated I became dizzy, very weak and shaky. Next day was nauseated all day, felt shaky, by 3 pm temp was 102, had heart rate in 150's. Both my knees were swollen, both legs were tingly. I took Motrin and Tylenol and most symptoms resolved by morning. Friday morning, I still felt weak but other symptoms resolved. I was not expecting the inflammatory response which is why I am letting y'all know. The patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: negative on 21Jan2021. The outcome of the event Very weak not recovered, inflammatory response was unknown and of the rest events was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
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| 40 | 2021-02-08 | difficulty swallowing |
hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she f...
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hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.
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| 40 | 2021-02-08 | vomiting, diarrhea |
on the morning on 2/6/2021 at 6am, swollen lymph nodes under left arm, migraine, vomiting and diarrh...
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on the morning on 2/6/2021 at 6am, swollen lymph nodes under left arm, migraine, vomiting and diarrhea, fever 99.8. Did not feel well through 2/8/2021.
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| 40 | 2021-02-11 | nausea, vomiting |
About 12 hours after the vaccine I developed headache, fever 100.5, nausea and vomiting, and red ra...
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About 12 hours after the vaccine I developed headache, fever 100.5, nausea and vomiting, and red rash across my chest up to my neck and under both breasts. All symptoms but the rash improved the following day. I went to have my 8 week pregnancy US 6 days after this second vaccine dose and there was no fetal heart rate. The baby measured 8.7mm and there should be a heart rate when the baby measures >7mm. I had all of my pregnancy symptoms up through the day of the vaccine and then they disappeared the day my vaccine symptoms improved. I do not have a history of miscarriage.
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| 40 | 2021-02-14 | nausea, decreased appetite, diarrhea |
red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the w...
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red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient
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| 40 | 2021-02-16 | nausea, vomiting |
Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of brea...
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Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of breath. Within 30 minutes she had nausea, emesis and a strange feeling in her mouth/throat. Patient was monitored and did not require EpiPen. She was given Benadryl. She was recommended to not have a second injection due to immediate allergic reaction. She did
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| 40 | 2021-02-17 | vomiting |
tired; headache; faint; vomit; This is a spontaneous report from a contactable consumer reported for...
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tired; headache; faint; vomit; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female received the first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via intramuscular on 04Feb2021 18:00 into left arm at a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT). On 05Feb2021 5:30, the patient experienced faint and vomit and on 16: 00, more vomit, tired and headache all day. No treatment received for the events. Since the vaccination, the patient has not tested for COVID 19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 40 | 2021-02-21 | nausea | fatigue low grade fever 100.9 chills nausea lasted for 24 hours |
| 40 | 2021-02-21 | nausea, diarrhea |
malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to ...
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malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to focus, and fatigue - day 3-6 chills- day 7 tingling in legs and feet/hands - day 4 and continue off an off for past 2.5 weeks after vaccine headaches- continued off and off for past 2.5 weeks
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| 40 | 2021-02-22 | nausea |
Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (pat...
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Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea
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| 40 | 2021-02-22 | nausea, diarrhea |
Evening of vaccine starting around 3 pm I had Diarrhea, Nausea, Headache, & Fatigue. Over night I ha...
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Evening of vaccine starting around 3 pm I had Diarrhea, Nausea, Headache, & Fatigue. Over night I had chills so possible fever but I did not check it. Next morning woke up with Full Body Aches, Very Fatigued, Headache, Injection Site Pain and Swelling.
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| 40 | 2021-02-22 | nausea |
Excess gas after 2 hours of injection and nausea. 20 hours - lower abdominal pain with feeling of ...
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Excess gas after 2 hours of injection and nausea. 20 hours - lower abdominal pain with feeling of having to use the bathroom
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| 40 | 2021-02-22 | nausea |
Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminoph...
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Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminophen, I felt very dizzy, nauseous, stay up, couldn't talk, after I drank cold water, I started with profuse sweating followed by chills, also had lower abdominal pain and pain on the left side of the chest. I went to the bathroom and did not have diarrhea. I was finally able to get up with help from my wife. Slow walking. The event lasted about 15 minutes. Since then I've take acetaminophen every 4 hrs.
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| 40 | 2021-02-25 | vomiting | Headache, fatigue, vomiting, fainting, muscle soreness, digestive issues. |
| 40 | 2021-02-25 | appendicitis, diarrhea, abdominal pain, vomiting |
Patient noted onset of diffuse abdominal pain on 2/25/21. This was accompanied with urgency with lo...
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Patient noted onset of diffuse abdominal pain on 2/25/21. This was accompanied with urgency with loose stools. Subsequently, the patient had persistent vomiting throughout the night. She denies fevers or chills. She has never had similar symptoms in the past. She reports that the abdominal pain localized to the right lower quadrant.
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| 40 | 2021-02-28 | abdominal pain upper |
On January 22nd, I began to develop left upper quadrant pain. I was started on Cipro and Flagyl and ...
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On January 22nd, I began to develop left upper quadrant pain. I was started on Cipro and Flagyl and took that for 7 days. After a couple days I was no better, pain was worse. I underwent a CT scan of abd/pelvis and was found to have Colitis. I have no history of this. I still was not improving so I was started on steroids (prednisone). Pain improved somewhat, but did not resolve. I then underwent a colonoscopy that demonstrated active and focal colitis in multiple areas of my colon. Again, I have no history of this. I spoke with my PCP who recommended that I not take the second dose, and report this to CDC as a possible hyper immune response.
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| 40 | 2021-02-28 | abdominal distension, nausea, diarrhea, decreased appetite |
Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, ...
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Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, then burping that tasted and smelled sulfur-like. Around 4am 3/1/21 woke up to nausea and diarrhea. Did not go to work. Slept on and off . Drank water and ate crackers. Took Immodium and it helped for a few hours. As on 7:30pm 3/1/21, I am still nauseated and have diarrhea . No energy to do any daily activities. Been laying down the entire day. Exhausted and out of breath going up the stairs to bedroom.
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| 40 | 2021-02-28 | nausea |
arm pain; fever; chills; headache; muscle aches; nausea; This is a spontaneous report from a contact...
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arm pain; fever; chills; headache; muscle aches; nausea; This is a spontaneous report from a contactable other HCP. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in right arm on 26Jan2021 at a single dose for COVID-19 immunization. There were no relevant medical history was not reported. there were no known allergies.Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received the first dose ofbnt162b2 on 06Jan2021 in right arm and experienced arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. After the 2nd vaccine, the patient experienced arm pain, fever, chills, headache, muscle aches and nausea on an unspecified date. there outcome of the events was recovering. There was no treatment for the events. The patient was not tested for COVID-19 prior and after the vaccination. Information on the lot/batch number has been requested.
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| 40 | 2021-03-01 | difficulty swallowing, decreased appetite |
Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath,...
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Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath, rapid heart beat, flush feeling, intense shaking (especially in legs), pain in chest, lightheadedness, dizziness (ruled anxiety) and was monitored for 40 minutes. Was given orange juice and water and allowed to remove mask to catch breath. Almost everyday since this event, the same event keeps repeating it self (almost daily for 3 weeks). I am unable to control these episodes. Emergency department (ED) has been called and I have gone to see my nurse practitioner. Been trying to make an appointment with my doctor for this week. I have lost 5 pounds (down to 105 lbs. so I can't afford to loose more weight) since this first happened and I have also lost my appetite and unable to function normally.
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| 40 | 2021-03-02 | nausea |
chills; fatigue; migraine-like headaches; dizziness; nausea; migraine-like headache and fatigue seve...
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chills; fatigue; migraine-like headaches; dizziness; nausea; migraine-like headache and fatigue severe enough to prevent normal activity; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), intramuscularly into the left arm on 28Jan2021 14:15 at a single dose for COVID-19 immunisation. Medical history included Polycystic ovarian syndrome (PCOS), depression, obesity and allergies to latex. Patient was not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), bupropion hydrochloride (WELLBUTRIN), colecalciferol (VITAMIN D) and cyanocobalamin (VITAMIN B12). The patient previously took tetracycline and experienced drug allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscularly into the right arm on 06Jan2021 03:15 PM at a single dose for COVID-19 immunisation. On 28Jan2021 20:00, patient experienced chills, fatigue, migraine-like headaches, dizziness, nausea and migraine-like headache and fatigue severe enough to prevent normal activity. The events were reported as non-serious. The patient did not receive any treatment for the events reported. Outcome of events was unknown.
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| 40 | 2021-03-03 | indigestion |
After 1st dose, had some hearing loss due to fullness in ears, took 2 weeks for symptoms to subside....
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After 1st dose, had some hearing loss due to fullness in ears, took 2 weeks for symptoms to subside. Since 1st dose, have had 4 HSV1 cold sores come about. After 2nd dose experiencing severe heartburn. Also continue to have HSV1 cold sore outbreaks.
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| 40 | 2021-03-03 | nausea |
Chills, sweats, fever 102.5+ for about 18 hours, body aches/pains (including bottoms of feet and pal...
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Chills, sweats, fever 102.5+ for about 18 hours, body aches/pains (including bottoms of feet and palms of hands), headaches, nausea.
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| 40 | 2021-03-04 | difficulty swallowing, nausea |
At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating a...
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At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating and very anxious. She quickly became pale and fainted. At 0925 she was awoken using a cold pack to her face and chest. Her vital signs were taken and stable. She continued to feel anxious, her nausea went away. She still felt dizzy and her fingers were tingling, at approximately 0934 she felt it difficult to swallow and like something was "swollen/tight" in her throat. Lungs were clear, she was swallowing normally. At 0940 she felt her neck still "swollen", upon assessment her submandibular nodes were enlarged to palpation. Benadryl 25 mg orally x1 was given at 0945, vital signs remained stable. She began to feel better at approximately 10:00 am, she recovered and was able to ambulate. A co-worker took her home at 10:51 am.
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| 40 | 2021-03-07 | diarrhea, nausea |
Severe Fatigue; moderate nausea; severe headache; moderate muscle aches; mild diarrhea; This is a sp...
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Severe Fatigue; moderate nausea; severe headache; moderate muscle aches; mild diarrhea; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 03Feb2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN (hypertension), depression, anxiety, RLS (Restless leg syndrome) and insomnia. Patient was not pregnant at the time of vaccination. Concomitant medication included lisinopril, trazodone, clozapine, pramipexole dihydrochloride (MIRAPEX), duloxetine hydrochloride (DULOXEE). The patient experienced severe fatigue, moderate nausea, mild diarrhea, severe headache, moderate muscle aches on 03Feb2021 10:00 with outcome of recovering. No treatment was received. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination. Information on the lot/batch number has been requested.
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| 40 | 2021-03-07 | vomiting, nausea |
chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous...
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chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.
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| 40 | 2021-03-14 | appendicitis |
a female patient at the hospital with appendicitis; This is a spontaneous report from a contactable ...
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a female patient at the hospital with appendicitis; This is a spontaneous report from a contactable physician. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , batch/lot and expiry unknown), via an unspecified route of administration on 22Feb2021 at a single dose for covid prevention. The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of Covid vaccine on 03Feb2021 (40 years) for Covid-19 immunisation. 4 days after getting her second dose of the Pfizer COVID Vaccine, patient was in the hospital with appendicitis on 26Feb2021. Patient was hospitalized, and he believes the patient was heading into the operating room (OR) now. It was confirmed that the patient had no other vaccines on the same day as both her COVID vaccine doses. The causality was reported as "unrelated". Information on the Lot/batch number has been requested.; Sender's Comments: In agreement with the reporting physician, the company considers that the event appendicitis is unrelated to suspect vaccine BNT162B2. Appendicitis is most likely an intercurrent condition. There is no plausible mechanism implicating BNT162B2 to the reported event based on the drug known safety profile.
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| 40 | 2021-03-28 | nausea, vomiting |
On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/202...
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On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/2021 Additional hearing muffled was was noticeable 3/16/2021: severe migraine, throwing up, nauseous 3/17/2021: facial rash prominent **hearing loss deemed permanent, ringing continuous
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| 40 | 2021-04-01 | nausea, diarrhea, decreased appetite, abdominal pain upper |
1/19/2021 vaccination. Felt flu like symptoms, body aches, feverish. I reported to every day on hea...
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1/19/2021 vaccination. Felt flu like symptoms, body aches, feverish. I reported to every day on health check-in. Muscle spasms, diarrhea, could not keep down water, HA, fatigue, lethargic. I thought I was dying. 1/21 0400am ER 1/22 ER 1/23 ER 1/24 ER; admitted inpatient to hospital. 11 Days inpatient. Nausea, vomiting, diarrhea, feverish, malaise, gastric spasms, HA, *12/2020 Gastrectomy *Symptoms lasted whole duration in hospital. Could not keep any liquids down.
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| 40 | 2021-04-06 | nausea |
dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, ...
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dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, chills the first night, pain and swelling in neck and spine only at night for 2 nights , very slight headache, slight fatigue and nausea and weakness after naps, then fine by day 3 then suddenly this morning I had slight chest pain (pressure) and severe vertigo and fell in the bathroom, bp normal, temperature normal, spo2 nornal, normal hr, i had no choice but to report to work or i would lose my job (teaching in private school)
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| 40 | 2021-04-12 | difficulty swallowing |
had swelling of cheeks, lips, cough , trouble swallowing about 30 minutes after vaccine administrati...
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had swelling of cheeks, lips, cough , trouble swallowing about 30 minutes after vaccine administration
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| 40 | 2021-04-15 | difficulty swallowing |
About 2-5 minutes after shot, I couldn?t swallow. My throat muscles just wouldn?t work, but it was ...
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About 2-5 minutes after shot, I couldn?t swallow. My throat muscles just wouldn?t work, but it was really sporadic like once or twice every 30 seconds-2 minutes I was not able to swallow. After 30 minutes of no worsening and waiting at vaccine site, my throat became itchy on my drive home and i had to clear it often. Rarely this happens to me if I eat honeydew melon or drink soymilk. I went to Urgent Care, throat looked open and they told me to take Benadryl. I?m curious if you?ve had reports like this of sporadic throat inoperation and if it will happen worse with the second dose.
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| 40 | 2021-04-20 | nausea |
At 1400, nausea and yea he started. By 1800, started to become tachycardic. Took Bystolic as order...
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At 1400, nausea and yea he started. By 1800, started to become tachycardic. Took Bystolic as ordered. The morning of 2/2/2021 awoke at 0600 with shortness of breath, tachycardia, hypoxia, headache, body ache, chills, nausea, and dizziness. VO2 max took a noticeable drop per garmin vivoactive 3. PCP was notified and instructed to monitor. Cardiologist and neurology were consulted and prednisone taper given on 03/05/2021. Shortness of breath and tachycardia slowly changed to only on exertion improved until finally ending 3/21/2021. Continued to have palpitations, headache, and body aches until about 04/07/2021.
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| 40 | 2021-04-24 | vomiting, nausea |
Diminished ovarian reserve/diminished reserve; fever; chills; hot flashes; nausea; vomiting; migrain...
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Diminished ovarian reserve/diminished reserve; fever; chills; hot flashes; nausea; vomiting; migraine headache; vertigo; weakness; They obtained an FSH level and it had skyrocketed from previous values not long before; my ovaries had shrunk in size by approximately half; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), first dose via intramuscular, administered in right arm on 19Dec2020 09:30 at a single dose (lot number and expiry date were not reported); and then received the second dose on 02Jan2021 09:30 (lot number and expiry date not reported), intramuscularly administered in right arm as a single dose; for COVID-19 immunisation. Medical history included eosinophilic esophagitis and asthma. The patient had no known allergies. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications which were taken in two weeks prior to vaccination included bupropion hydrochloride (WELLBUTRIN) and ethinylestradiol, norethisterone acetate (LOESTRIN), taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. On 19Dec2020, the patient experienced diminished ovarian reserve. Patient stated that she was extremely symptomatic after both vaccines and starting on 19Dec2020 had experienced fever, chills, hot flashes, nausea, vomiting, migraine headache, vertigo and weakness. The hot flashes persisted and worsened after each subsequent vaccine, prompting her to go to my MD. They obtained an FSH level on 19Dec2020 and it had skyrocketed from previous values (dates unspecified; unknown results) not long before. An ultrasound on 19Dec2020, showed that her ovaries had shrunk in size by approximately half and she had diminished reserve. Patient was now on supplemental hormones and will be for many years to come as she was only 40. Patient know the vaccine caused this. It was too great of a coincidence. Adverse events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. As a result of the events reported patient was now on hormonal replacement therapy. The patient was tested for covid post vaccination which included nasal swab/Covid test on 14Mar2021 as negative. The outcome of the events reported was not recovered. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded, for events fever, chills, hot flashes, nausea, vomiting, migraine headache, vertigo and weakness, conversely the suspect drug is considered very unlikely related for other gynecological disturbances. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
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| 40 | 2021-04-24 | diarrhea, nausea |
Severe GI cramping; diarrhea; nausea; This is a spontaneous report from a contactable nurse, the pat...
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Severe GI cramping; diarrhea; nausea; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 10Feb2021 12:15 (Batch/Lot Number: EN6201) (at the age of 40-years-old) as single dose for covid-19 immunisation. The patient medical history included none. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm Right on 20Jan2021 11:00 (Batch/Lot Number: EL-9261) (at the age of 40-years-old) for covid-19 immunisation. On 12Feb2021 03:00, the patient experienced severe GI cramping, diarrhea and nausea. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events included 2 litres of fluids, IV, IM and po medications. The outcome of the events was recovering.; Sender's Comments: Based on temporal association and know drug profile a contributory role of BNT162B2 to the reported severe GI cramping, diarrhea and nausea cannot be totally excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-04-24 | abdominal pain |
diverticulitis; perforated colon; it caused an abdominal infection and inflammation; she is still ha...
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diverticulitis; perforated colon; it caused an abdominal infection and inflammation; she is still having a little bit of pain in her abdomen/she was in a lot of pain but is mostly better; This is a spontaneous report from a contactable consumer (pateint) via a Pfizer-sponsored program COVAX Support. A 40-year-old female patient received the first dose of bnt162b2, via an unspecified route of administration, administered in right arm on 17Mar2021 10:00 (Lot number was not reported) as single dose for covid-19 immunisation. The patient and concomitant medications were not reported. The patient experienced diverticulitis, perforated colon, abdominal infection and inflammation on 30Mar2021; she is still having a little bit of pain in her abdomen/she was in a lot of pain but is mostly better on an unspecified date. The patient was hospitalized for diverticulitis, perforated colon, abdominal infection and inflammation from 30Mar2021 to 01Apr2021. The all events were resulted in Emergency Room and Physician Office. Patient was due for second dose of Pfizer BioNTech Covid vaccine tomorrow (08Apr2021) but was hopitalized last week for diverticulitis and a perforated colon. She was released from the hospital last Thursday and is currently taking Metronidazole 500mg three times a day and ciprofloxacin 500mg1 tablet by mouth every 12 hours. At her follow up today (07Apr2021) the doctor was unsure of a recommendation. She lost her vaccination card. She mentioned that she will be having the 2nd dose tomorrow 08Apr2021 and she wants to know if possible since she doesn't have the card. She mentioned that she got hospitalized last week and she is under medication due to abdominal infection and she is taking antibiotics until next 2 weeks. She was in the hospital for diverticulitis and a perforated colon two nights last week and was pumped with a ton of antibiotics and is currently on antibiotics. It caused an abdominal infection and inflammation and she received five bags of antibiotics and was sent home with two different antibiotics, one for 2 weeks and one for 3 weeks. She is essentially from tomorrow to two weeks on antibiotics and didn't know if it would be an issue with getting the vaccine. She asked her family physician and he said he would probably wait because there is a chance it would counteract with the vaccine. Caller states her daughter lost her vaccination card and asks if this is going to be an issue as long as she goes to the same place she went to get her second shot, states this must have happened to other people. During that time at the hospital she had a total of five bags of antibiotics. She was still having a little bit of pain in her abdomen and probably why she was on antibiotics for two weeks. She was in a lot of pain but is mostly better. About the treatment, patient stated she was on morphine while in the hospital and they did a CT scan with dye. Patient stated all her blood work came back healthy. The outcome of the event abdominal pain was recovering, other events was unknown. Information on the lot/batch number has been requested.
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| 40 | 2021-04-24 | nausea |
lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries wi...
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lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries with my lip and teeth; injuries with my lip and teeth; chills; headache; nausea; injection site pain; muscle pain; unwell; This is a spontaneous report from a contactable consumer. A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06Apr2021 17:30 (Batch/Lot Number: EW0151) as single dose (at the age of 40 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, dose 1, (lot number=EN6204), on 13Mar2021 04:00 PM, administered on left arm for COVID-19 immunisation. The patient stated, "I got various symptoms such as chills, headache, nausea, injection site pain, muscle pain, unwell, and one day after getting the shot (on 06Apr2021 20:00) and on 07Apr2021, I lost my consciousness and fell down to the front on floor and it caused injuries with my lip and teeth. My upper front teeth was broken". The patient received no treatment. The patient was rushed to the emergency room and physician was visited. The outcome of the events was not recovered.
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| 41 | 2020-12-31 | nausea | Migraine x 4 days, nausea off and on x 3 days, itching arms and stomach x 2 hours, fatigue x 2days |
| 41 | 2020-12-31 | nausea | Moderate to severe nausea for the past 6 days. |
| 41 | 2020-12-31 | nausea |
Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followe...
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Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followed, observed by hospital staff for approximately 45mins then taken to ER, discharged with 90mins. Body aches and chills for 1-2days. dizziness, nausea, lightheaded for 4-5 days to follow.
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| 41 | 2021-01-01 | decreased appetite |
Day after vaccine experienced weakness, chills fatigue. Day four felt better went snowboarding and b...
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Day after vaccine experienced weakness, chills fatigue. Day four felt better went snowboarding and balance was off and fell several times. Body aches and pain continued. 12/29/2020 at 8 pm had fever of 100. 12/30 fever 103f chills, slept almost all day loss of appetite. 12/31 no fever in the morning but acting different than normal. In after non could not tell my husband child?s name went to the ED where I was admitted for altered mental status. Discharge today with altered mental status, unspecified. Wife still has headache but normal level of consciousness.
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| 41 | 2021-01-02 | diarrhea | Sore arm, diarrhea, low grade fever. No treatment. |
| 41 | 2021-01-03 | vomiting, nausea |
12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, ...
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12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.
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| 41 | 2021-01-03 | abdominal pain upper, nausea | Fever, Headache, Nausea, stomach cramping, vivid dreams |
| 41 | 2021-01-04 | difficulty swallowing |
20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP ...
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20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP chest heavy face and nose itchy @ 3:15 pm Benadryl 25 mg IM + difficulty swallowing.
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| 41 | 2021-01-04 | nausea, vomiting |
Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Na...
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Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Nausea; Vomiting; Worsening headache w/ photophobia; Subjective fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=59267-1000-1 /EH9899), via intramuscular on 28Dec2020 09:45 at single dose on her right arm for Covid-19 immunization. Medical history included psoriasis. The patient had no known allergies. Allergies to medications, food, or other products was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that 6h after administration on 28Dec2020 16:00, the patient experienced fatigue, myalgia, injection site pain; 10h after (in addition to above) on 28Dec2020, the patient experienced headache (frontal), joint pain, chills and 12-28h after (in addition to above) in Dec2020, the patient experienced nausea, vomiting, worsening headache w/ photophobia, subjective fever, joint pain. The patient was not received any treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 41 | 2021-01-04 | nausea, diarrhea |
I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on t...
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I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on the 25th of December, then I started having symptoms at 3:30 am on December 29th I went and got tested that morning and the test was positive for covid-19. I then went home to quarantine. I have experienced fever, body aches, headaches, nausea, diarrhea, sinus pressure, chills, loss of taste and smell, weakness and fatigue. But have been able to continue to recover at home.
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| 41 | 2021-01-04 | nausea |
Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash ...
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Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen
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| 41 | 2021-01-04 | vomiting, nausea |
On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and...
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On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and headaches, with nausea and vomiting and a tight chest sensation. The doctor gave the order of solumedrol 80mg IV, TORADOL 30MG IV, TORADOL 30MG Im, Zofran 4 IV and .9 NSS 500mL IV. Afterwards the patient was discharged from the emergency room.
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| 41 | 2021-01-04 | nausea, vomiting |
episode of vertigo; vomiting; nausea; This is a spontaneous report from contactable physicians (one ...
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episode of vertigo; vomiting; nausea; This is a spontaneous report from contactable physicians (one is the patient). A 41-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EJ1685), via an unspecified route of administration on the left arm on 22Dec2020 at 12:45 at a single dose for immunization. Medical history included benign paroxysmal positional vertigo, but the patient has not had a flare of this condition in 3.5 years. The patient has no allergies to medications, food, or other products. Concomitant medications were not reported. The patient who has a history of Benign Paroxysmal Positional Vertigo (BPPV) had not had a flare of this condition in 3.5 years. Previously, it has only been brought on by scuba diving, then she woke up the day after receiving the Pfizer COVID 19 vaccine, on 23Dec2020 at 06:30 with an episode of vertigo consistent with prior episodes of BPPV. She has associated nausea and vomiting, and her symptoms mostly resolve with doing home exercises, rest and time. On 29Dec2020, that is day 7 after the vaccine and she still have mild vertigo. She has no fevers, chills, or myalgias. She stated that perhaps it was a coincidence but thought it might be worth reporting, and she fully intend to get the second Pfizer vaccine when available. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and no other medications were received by the patient within 2 weeks of vaccination. The events nausea and vomiting resolved in 2020 while the rest of the events was resolving.
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| 41 | 2021-01-04 | diarrhea, abdominal discomfort, nausea |
nausea; diarrhea; upset stomach; This is a spontaneous report from a contactable nurse (patient hers...
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nausea; diarrhea; upset stomach; This is a spontaneous report from a contactable nurse (patient herself). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EH9899, expiration date: unknown), intramuscularly on the right arm on 21Dec2020 at 07:15 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included asthma. The patient had no known allergies; no allergies to medications, food, or other products. Concomitant medications included montelukast sodium (SINGULAIR) and budesonide, formoterol fumarate (SYMBICORT). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Dec2020 at 06:00, the patient experienced nausea, diarrhea, and upset stomach, which were assessed as non-serious. The patient did not receive treatment for the adverse events. The patient was recovering from the events "nausea, diarrhea, and upset stomach."
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| 41 | 2021-01-04 | vomiting, diarrhea |
very sick; chills; fever; diarrhea; vomiting; This is a spontaneous report from a contactable other ...
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very sick; chills; fever; diarrhea; vomiting; This is a spontaneous report from a contactable other hcp. A 41-year-old female patient received bnt162b2 (lot number: EH9899), intramuscularly at arm left, first dose on 22Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got the vaccination yesterday (22Dec2020) and she has been very sick, chills, fever, diarrhea and vomiting. Didn't come to work today and she claims is getting worse. The event was unwitnessed by staff and the reported by client employer. Age at vaccination is 41 years old. Adverse event started on 23Dec2020. The event was reported as non-serious. The outcome of the events was unknown.
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| 41 | 2021-01-05 | difficulty swallowing |
mild supraglottic swelling of my aryepiglottic folds; feel difficulty swallowing (globus); allergic ...
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mild supraglottic swelling of my aryepiglottic folds; feel difficulty swallowing (globus); allergic response; This is a spontaneous report from a contactable physician. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 23Dec2020 12:30 at single dose for COVID-19 immunisation. Medical history included allergies to medications, food, or other products: Penicillin. There were no concomitant medications. The patient previously took benzoyl peroxide and experienced allergies. The patient experienced stated that on 23Dec2020 12:31, "I am an ENT surgeon. I received the first dose of the vaccine at 12:30pm. Within 1-2 minutes I started to feel difficulty swallowing (globus). I reported this to the nurse and she offered me ginger ale. My symptoms worsened and then stabilized after 10 minutes. I went upstairs and got the residents to perform a fiberoptic nasoendoscopy and this demonstrated mild supraglottic swelling of my aryepiglottic folds. I choose not to receive treatment as I did not want to dampen my allergic response and as an ENT surgeon manage airways on a daily basis. I stayed at the hospital for a further 6 hours and continued to work. My symptoms resolved after 9 hours". The outcome of the events was recovered on 23Dec2020.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event laryngeal oedema cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-06 | nausea, diarrhea |
24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site...
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24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site, 48-96 nausea and diarrhea X24hrs, severe migraine, improving fatigue and hives. treated with rest, advil , and Benadryl
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| 41 | 2021-01-06 | nausea | Fever 104, chills, nauseas, swollen lymph's armpits, severe headaches |
| 41 | 2021-01-06 | abdominal pain, nausea, vomiting |
Fever, chills, body aches, ( muscle and joint pain), pain at injection site, nausea, 1 episode of vo...
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Fever, chills, body aches, ( muscle and joint pain), pain at injection site, nausea, 1 episode of vomiting, abdominal pain
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| 41 | 2021-01-06 | nausea |
Moderate joint aches and nausea. Started 18 hours after the vaccine and lasted 24 hours. Very sore ...
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Moderate joint aches and nausea. Started 18 hours after the vaccine and lasted 24 hours. Very sore right arm lasting about 72 hours.
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| 41 | 2021-01-06 | vomiting | Vomiting, diaphoresis |
| 41 | 2021-01-06 | diarrhea, nausea |
site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and...
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site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and neck side of injection 24-96hrs. Treated with rest, advil, Benadryl
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| 41 | 2021-01-06 | nausea |
woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F...
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woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F. Fever did not respond to 600 mg ibuprofen. Later that day developed headache and body aches. Pain at injection site present as well.
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| 41 | 2021-01-07 | abdominal pain, diarrhea |
Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General ache...
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Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General aches; fatigue; This is a spontaneous report from a contactable healthcare profess. A 41-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), intramuscular on 29Dec2020 14:45 at a single dose for Covid-19 immunization. Medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), calcium D, sertraline hydrochloride (ZOLOFT), and probiotics. The patient previously took ampicillin sodium (OMNIPEN) and BACTRIM DS and experienced allergies. On 30Dec2020, at 04:45 PM, the patient experienced abdominal cramping and diarrhea on pm overnight, injection site soreness/arm pain, general aches and fatigue. The patient did not receive any treatment for the events. The patient has no Covid prior to vaccination and did not take Covid test post vaccination. The outcome of the events was recovering.
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| 41 | 2021-01-07 | diarrhea, nausea | Diarrhea, nausea, and fatigue |
| 41 | 2021-01-07 | diarrhea, vomiting |
Fever; Chills; Vomiting; Diarrhea; This is a spontaneous report from a contactable other healthcare ...
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Fever; Chills; Vomiting; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm from 02Jan2021 08:00 to 02Jan2021 08:00 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 03Jan2021 03:30, the patient experienced fever, chills, vomiting, and diarrhea. The patient underwent lab tests and procedures which included Sars-cov-2 (Nasal Swab) test on Jan2021: with negative result post vaccination. The outcome of the events was recovering. No treatment was given for the events. No follow-up attempts are possible, information about batch number cannot be obtained.
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| 41 | 2021-01-07 | nausea, vomiting | Headache and vomiting nausea and gastro problems |
| 41 | 2021-01-07 | nausea, vomiting |
NauseaVomiting,HYPERtension & HYPERglycemia Narrative: Employee received vaccine. Seven minutes late...
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NauseaVomiting,HYPERtension & HYPERglycemia Narrative: Employee received vaccine. Seven minutes later, she began experiencing nausea and vomiting. She vomited, and a STAT team was called and we transported her to ER for evaluation. In ER, she had BP of 157/106, and blood glucose of 288. Other vitals were O2 saturation of 100%. She is diabetic and states her fingerstick glucose right before lunch at 12N was 120. After about 30 minutes observation in ER she was released, nausea subsided and she did not require antiemetic medication.
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| 41 | 2021-01-07 | nausea |
Patient felt chilled and light headed. She was brought to a room and laid in a bed. She complained o...
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Patient felt chilled and light headed. She was brought to a room and laid in a bed. She complained of nausea and dizziness with standing. Vital signs were monitored. Oxygen saturation remained at 100%. BP 120s-130s/80s. She did not complain of any shortness of breath or wheezing. She did not complain of any itching. No skin or mucocutaneous findings. She was monitored for 4 hours and given 1L of IV fluids, zofran and ativan. She returned to baseline over the monitoring period.
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| 41 | 2021-01-07 | nausea |
Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something...
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Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something in throat". Vital signs obtained at 1853 175/96, HR 68, temp 98.3 and o2 sat 99%. Repeat VS at 1903 167/103, HR 78, O2 sat 100%. Having pulse ox desaturations while speaking. Patient transported to ED in stable condition. Patient monitored in ED with resolution of symptoms and was discharged.
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| 41 | 2021-01-07 | retching, nausea |
Sore arm Headache- all over pain like a sinus infection body sweats nausea weakness dry heaves fatig...
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Sore arm Headache- all over pain like a sinus infection body sweats nausea weakness dry heaves fatigue
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| 41 | 2021-01-07 | nausea | body aches, fever, nausea, sore arm, up all night |
| 41 | 2021-01-07 | diarrhea | chest tightness arm pain nausea diarrhea body aches fatigue lost work two days |
| 41 | 2021-01-07 | nausea |
felt a strange feeling in the right-side of the neck that ended around the base of the head/Since th...
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felt a strange feeling in the right-side of the neck that ended around the base of the head/Since then, it just doesn't feel right; felt a strange feeling in the right-side of the neck that ended around the base of the head/Since then, it just doesn't feel right; nausea; Since then, it just doesn't feel right; since the vaccine have stiffness when turning my neck; a few headaches; This is a spontaneous report from a contactable nurse (patient) A 41-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, intramuscularly on 21-DEC-2020 09:30 (at the age of 41-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was none. The patient did not have allergies to medications, food, or other products. Concomitant medication included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Soon after receiving the vaccine in my right arm, she felt a strange feeling in the right-side of the neck that ended around the base of the head and nausea on 21Dec2020. Since then, it just doesn't feel right and still have the nausea and since the vaccine have stiffness when turning my neck on 21Dec2020. "I can't really describe it much more than it feels strange and hasn't gotten better". The patient had a few headaches on 21Dec2020 but am unsure if that's related to the vaccine as they didn't occur immediately after receiving it. The events felt a strange feeling in the right-side of the neck that ended around the base of the head, nausea, Since then, it just doesn't feel right, since the vaccine have stiffness when turning my neck and a few headaches did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. Outcome of the events felt a strange feeling in the right-side of the neck that ended around the base of the head, nausea, Since then, it just doesn't feel right, since the vaccine have stiffness when turning my neck and a few headaches was recovering. Since the vaccination, the patient has not been tested for COVID-19.
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| 41 | 2021-01-07 | nausea | headache, sore throat, light headed, nauseous, fatigue, cold and sweaty-no fever |
| 41 | 2021-01-08 | diarrhea, nausea, vomiting |
Depression, Dizziness, Headache, Myalgia, Diarrhea & NauseaVomiting Narrative: On 12/28/20 continue...
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Depression, Dizziness, Headache, Myalgia, Diarrhea & NauseaVomiting Narrative: On 12/28/20 continue with headache, abdominal malaise, Dizziness. But referred is improving.
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| 41 | 2021-01-08 | nausea |
Had chill soon after the injection and about 5 minutes later had slight nausea, I was told to stay ...
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Had chill soon after the injection and about 5 minutes later had slight nausea, I was told to stay 15 more minutes for observation . About 30 minutes or so after the injection, I had sever nausea. The person at the observation sent me to ER for close monitoring . After couple hours of sever nausea My body started itchy for few hours without hives. In ER, prescribed zofran but didn?t take it. Stayed ER for few hours and I was released
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| 41 | 2021-01-08 | nausea | Nausea, chills, fatigue for 12 hours. Treated with Advil at home, resolved. |
| 41 | 2021-01-08 | vomiting, nausea | NauseaVomiting, HYPERtension & HYPERglycemia |
| 41 | 2021-01-08 | decreased appetite, nausea |
Pfizer-BioNTech COVID-19 Vaccine- Woke up at 01:30 with extreme chills, body aches & fever 101.8. To...
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Pfizer-BioNTech COVID-19 Vaccine- Woke up at 01:30 with extreme chills, body aches & fever 101.8. Took 2 Tylenol & woke up at 0400 with a fever of 102.6, chills, body aches & horrible headache. I also had no appetite, nausea & developed fever blisters on lower lip. Lasted until Tuesday 12/29 & ended up going to the ER because the headache was so horrible & would not go away.
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| 41 | 2021-01-09 | diarrhea | Fever(low grade) , body aches, headaches, dirrhea, chills |
| 41 | 2021-01-09 | diarrhea |
I was exposed to a covid positive person on 12/15/2020, 13 days before receiving my first dose on 12...
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I was exposed to a covid positive person on 12/15/2020, 13 days before receiving my first dose on 12/29/2020. I started feeling unwell on 12/31/20. On 1/1/2021, chills and body aches started for two days. I continue to have daily headaches and off and on chills and body aches. Other symptoms are congestion, running nose and diarrhea.
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| 41 | 2021-01-09 | nausea |
Nausea, body aches, fever (100.1 max), headache, extreme fatigue. Fever one day, body aches, extreme...
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Nausea, body aches, fever (100.1 max), headache, extreme fatigue. Fever one day, body aches, extreme fatigue and headaches 2 days, normal fatigue and nausea about a week.
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| 41 | 2021-01-09 | nausea |
Nausea, headache, fatigue, muscle aches, fever (100.3) fever day one and 3. Headache muscle ache ...
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Nausea, headache, fatigue, muscle aches, fever (100.3) fever day one and 3. Headache muscle ache nausea and fatigue everyday so far.
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| 41 | 2021-01-10 | nausea |
12 hours after the inj had chills, myalgia, headache low grade fever and nausea. Developed pain in e...
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12 hours after the inj had chills, myalgia, headache low grade fever and nausea. Developed pain in external genitalia, Had ulcerations with bruising on 1/9/21. (Lesions)
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| 41 | 2021-01-10 | abdominal pain |
Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-...
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Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-- fever 101.3, body aches, chills, extreme fatigue, sore throat, dizziness, sinus congestion , abdominal pain, tender lymph nodes in neck HA and pain at injection site.
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| 41 | 2021-01-10 | abdominal pain upper, diarrhea |
Rectal bleeding; Stomach ache; Diarrhea; sick; This is a spontaneous report from a contactable consu...
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Rectal bleeding; Stomach ache; Diarrhea; sick; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program Pfizer First Connect. A 41-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right arm on 20Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. On 01Jan2021, the patient experienced: rectal bleeding, stomachache, diarrhea, sick; all assessed as medically significant. The clinical course was reported as follows: The patient received the first dose of the COVID-19 vaccine on 20Dec2020; as she was at high risk due to working with COVID patients in the hospital. The patient became sick on 01Jan2021. The patient experienced a stomach-ache, diarrhea, and rectal bleeding. When these events occurred, the patient went to the emergency room (ER). A doctor there prescribed the patient the antibiotics metronidazole 500 mg and cefdinir 300 mg. The patient was also scheduled to follow up with a gastrointestinal (GI) doctor. The patient called asking if she should get the second dose since she was taking antibiotics. The patient was scheduled for the second dose on 08Jan2020.The patient reported she had improved. The symptoms, at the time of the report, were not that bad. Therapeutic measures were taken as a result of rectal bleeding, stomachache, diarrhea, and sick. The clinical outcome of the events was recovering.
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| 41 | 2021-01-10 | difficulty swallowing |
palms of hands started to swell and itch. diaphoretic, then neck started to itch. extended to thro...
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palms of hands started to swell and itch. diaphoretic, then neck started to itch. extended to throat leading to difficulty swallowing
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| 41 | 2021-01-11 | abdominal pain | Body aches, fever 103, headaches, abdominal pain for 28 hours |
| 41 | 2021-01-11 | diarrhea, nausea |
Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot fla...
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Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; This is a spontaneous report from a contactable Nurse (patient). This 41-Year-old female Nurse (no pregnant) received first dose of BNT162B2 (Lot number: EJ1685) on 04Jan2021 09:00 AM on Left arm for COVID-19 immunization. Medical history was migraines. Concomitant drug was not reported. Known allergies: amoxicillin, cefaclor (CECLOR), ciprofloxacin hydrochloride (CIPRO), erythromycin, Zithromax. Patient experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days following injection on 05Jan2021 00:30 (reported as 04Jan2021 12:30 PM) with outcome was recovering. Treatment: Medication for nausea (zofran). Covid test post vaccination on 06Jan2021, result unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Follow-up attempt are not possible. No expected further information.
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| 41 | 2021-01-11 | nausea |
Onset of "kaleidoscope vision" at 10:50 AM, followed by headache, nausea, light sensitivity, and dif...
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Onset of "kaleidoscope vision" at 10:50 AM, followed by headache, nausea, light sensitivity, and difficulty focusing eyes (symptoms of ocular migraine). Severe symptoms lasted 5 hours, mild symptoms lasted through the evening and next day (today I still have a mild headache and nausea). I have previously had 1 migraine (~5 yrs prior) in the setting of repeated fume exposure during a renovation at my workplace, no other history of migraine.
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| 41 | 2021-01-11 | indigestion | Recipient reported heartburn sensation, and fatigue. |
| 41 | 2021-01-11 | abdominal distension |
a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin;...
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a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; This is a spontaneous report from a contactable consumer. A 41-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown) via an unspecified route of administration at Left arm on 04Jan2021 09:30 at SINGLE DOSE for covid-19 immunization. Medical history included irritable bowel syndrome. Concomitant medication included amoxicillin, ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C), colecalciferol (VITAMIN D), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). No other vaccine in four weeks. The patient had allergies to ciprofloxacin(CIPRO). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19.Since the patient got the vaccine, she had been experiencing a huge amount of gas and bloating as well acid and burning sensation in her throat and neck and chin on 04Jan2021 15:00. The outcome of the events was not recovered. No treatment received for the events. Information about Lot/Batch number is requested.
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| 41 | 2021-01-12 | nausea | 103 Fever 24 hrs chills 48 hrs tired 48 hrs nausea 72 hrs sweating 72 hrs headache 72 hrs |
| 41 | 2021-01-12 | nausea |
Employee received first vaccine 12/22/21. Developed hives on neck and face later that day. Took Bena...
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Employee received first vaccine 12/22/21. Developed hives on neck and face later that day. Took Benadryl routinely and Prednisone 10mg daily for three days with resolution of symptoms. Patient has a history of hives after flu vaccine, antibiotics, and childhood vaccines. Had second COVID vaccine 1/12/21. Developed hives on neck, arms, chest, and back. Also had a mild headache and nausea on 1/12/21 which have resolved. Is again taking Prednisone and Benadryl. Patient did not seek medical help. She has Prednisone on hand for these reactions since they are common for her.
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| 41 | 2021-01-12 | vomiting, nausea | Excruciating headache, dry mouth and eyes, Nausea and vomiting |
| 41 | 2021-01-12 | diarrhea, abdominal discomfort |
Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swellin...
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Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swelling with pain from forearm to shoulder. Woke on Saturday, 1/9/21 with enlarged/swollen lymph nodes under left arm, had headaches throughout the weekend. By Monday, 1/11/21 most symptoms had resolved with the exception of some arm soreness.
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| 41 | 2021-01-12 | nausea |
So within a few minutes I had numbness and coldness in the entire arm and a headache. Then maybe 10 ...
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So within a few minutes I had numbness and coldness in the entire arm and a headache. Then maybe 10 hrs later, nausea, numbness, body aches, joint pain, headache and fatigue.
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| 41 | 2021-01-12 | decreased appetite | fever loss of appetite headache/migraine body aches muscle cramps, rash |
| 41 | 2021-01-13 | abdominal discomfort |
01/08/21 reported around 3:30pm sick to stomach, 01/09/21 04:00am noted redness to right arm at inje...
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01/08/21 reported around 3:30pm sick to stomach, 01/09/21 04:00am noted redness to right arm at injection site.
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| 41 | 2021-01-13 | nausea |
10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days....
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10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days. 3rd day post injection nausea continued and started experiencing back/flank pain. 4 and 5th day post injection still have nausea/back pain and chest pain, headache. Overall tiredness and weakness. I was also tested for Covid and it was negative.
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| 41 | 2021-01-13 | nausea |
Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and no...
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Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot. This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.
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| 41 | 2021-01-13 | nausea |
Dizziness and nausea within 2 mins of the vaccine. Dizziness went away after 10 mins but nausea has ...
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Dizziness and nausea within 2 mins of the vaccine. Dizziness went away after 10 mins but nausea has remained for over 24hours.
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| 41 | 2021-01-13 | nausea | Fatigued, nausea, chills |
| 41 | 2021-01-13 | nausea |
I was approached by a person in the center at approx 1000 stating she had an employee that received...
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I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.
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| 41 | 2021-01-13 | nausea | Persistent Nausea Cough, post nasal drip Mild Headache, Neck and body ache, fatigue |
| 41 | 2021-01-13 | nausea |
Same night that I got the vaccine I got a headache and on the second day I started getting nauseas I...
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Same night that I got the vaccine I got a headache and on the second day I started getting nauseas I was aching I had a fever 102.8 I had chills, body aches, my muscles where hurting, I also felt the pins & needles on my feet everything lasted about 36hrs. The headache lasted about 3 days.
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| 41 | 2021-01-13 | vomiting, nausea, abdominal pain upper, diarrhea |
Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigu...
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Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigue, skin sensitivity. Treated with Tylenol and CBD lotion. Mostly resolved within 36 hours of onset.
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| 41 | 2021-01-13 | nausea, diarrhea |
not feeling well overall; nausea; diarrhea; chills; This is a spontaneous report from a contactable ...
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not feeling well overall; nausea; diarrhea; chills; This is a spontaneous report from a contactable Pharmacist (patient). This 41-Year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL0140), via an unspecified route of administration, on 06Jan2021 at 01:30 PM at single dose for COVID-19 immunisation. Vaccine location was Left arm. The patient was vaccinated at hospital, age at vaccination was 41-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included sambucus nigra (ELDERBERRY), colecalciferol (VITAMIN D), camellia sinensis (GREEN TEA). On 08Jan2021 at 12:00 AM, the patient experienced nausea, diarrhea, chills, not feeling well overall. The events were reported as non-serious. The patient was tested for Covid post vaccination however it was also reported that she was not tested (to be clarified). Outcome was recovering. No treatment was received for the events.
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| 41 | 2021-01-13 | nausea |
within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over for...
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within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over forty minutes to include hypertension, nape of neck "fullness", weakness, and tingling hands. HR in '70's initially then progressed to tachycardia in 130's. EMS called for ED transport.
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| 41 | 2021-01-14 | abdominal discomfort, nausea |
Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sic...
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Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sick to the stomach. When driving home from work, she instantly felt really hot and had a lot of flushing that felt like a hot flash. Hot all over. Had to pull over and take off layers of clothes. Sat with the air on in the car. Burning sensation when she got home felt like brillo pad was used on face. Burning sensation on cheek all the way down to chin. Face was really on fire. Today, the burning sensation have gotten better, but her cheeks still have prickly, tight sensation. Headache at 8pm yesterday when she was trying to go to bed at the back of the head. Felt like a lot of pressure.
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| 41 | 2021-01-14 | nausea |
Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, ext...
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Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, extremely high resting heart rate (over 100-usually under 60)
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| 41 | 2021-01-14 | vomiting |
I vomited several times; Severe headache; Muscle aches; Chills; Joint pain; Tiredness; Fever; This i...
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I vomited several times; Severe headache; Muscle aches; Chills; Joint pain; Tiredness; Fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration from 07Jan2021 10:00 at left arm, at single dose for covid-19 immunization. Medical history included COVID 19 positive 12Dec2020, the patient was diagnosed with COVID-19 prior to vaccination. Allergies to medications, food, or other products was reported no. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient received vaccine at 07Han2021 10:00PM (as reported). 4 hours after receiving the vaccine 07Jan2021 14:00 the patient vomited several times, the patient had and still have severe headache, muscle aches, chills, joint pain, tiredness and fever. The patient realized that these are side effects and not adverse reactions but she felt that they were quite severe and she thought it was due to the fact that she so recently had COVID 19. OTC meds were received for all events. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
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| 41 | 2021-01-14 | nausea |
Nausea; dizziness; fever; This is a spontaneous report from a contactable other healthcare professio...
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Nausea; dizziness; fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283), via an unspecified route of administration in the left arm on 08Jan2021 08:00 at a single dose for COVID-19 immunization. The patient's medical history included migraine and seasonal allergies. The patient was not pregnant at the time of vaccination. The patient have no known allergies to medications, food, or other products. Concomitant medications included melatonin and levocetirizine dihydrochloride (XYZAL). The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), intramuscular in the left arm on 18Dec2020 at the age of 41-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 08Jan2021 09:30, the patient experienced nausea, dizziness, fever. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious by the reporter.
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| 41 | 2021-01-14 | abdominal pain upper |
On 1/12 at about 6:30 AM, I felt muscle tightness on the left side. The whole right ring finger was...
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On 1/12 at about 6:30 AM, I felt muscle tightness on the left side. The whole right ring finger was numb and lock. Within minutes, I felt tingling sensations along all my fingers and thumbs. Then numbness at the tips. Then, both my hands were very cold. At about 2- 3, I fell groggy, tired. Then came the chill and fever, also light headaches. The numbness was gone. 1/13 I hit my right funny bone and my pinky, ring, and middle fingers were locked up tight. I tried to uncurl them. But they stayed locked. It lasted about 1-2 minutes. I got stomach pain around 5. 1/14 I have excessive phlegm at around 3pm and currently still have excessive phlegm. Then at around 10 pm, I had bad warped vertigo.
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| 41 | 2021-01-14 | nausea |
Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At app...
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Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At approximately 0400 + chills, HA, body aches, and nausea without emesis. + fever (Tmax 100.3), Patient reports yesterday took motrin/tylenol around the clock. Today (1/15), Patient reports no fever today but ?brain fog? and feelings of fatigue. Patient reports last dose of motrin 600 mg at 08:00. Patient reports she called off work yesterday due to not feeling well. Last day of work and shift - ?Tuesday, January 12th Home remedies? - Tylenol, motrin, rest Any improvement? ? mild improvement Recommendation? Patient encouraged to take ibuprofen and acetaminophen as outlined in the TCH Medical Directive. Patient encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. Patient reports she called out of work yesterday, next scheduled shift Monday (1/18). Patient educated to manage her RTW according to the TCH Illness in the Workplace policy. Patient verbalized back understanding and denied further questions at this time.
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| 41 | 2021-01-14 | nausea | lethargy, body aches, dizziness, numbness in arms, dizziness, nausea, high pulse rate |
| 41 | 2021-01-16 | difficulty swallowing |
Vax injection at 4:05 pm, Symptoms started at 4:10 pm. burning throat, difficulty swallowing, tight...
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Vax injection at 4:05 pm, Symptoms started at 4:10 pm. burning throat, difficulty swallowing, tightness in chest. 25 mg benadryl given with a little improvement. Symptoms return and worsen- 25 mg benadryl given and rapid response called. Taken to ED and admitted. Given 125 mg of solu-medrol IV and albuterol inhaler. Symptoms eased and discharged to go home. 01-15-2021- 4:30am woke with burning in throat mild difficulty swallowing. Took 50 mg benadryl and inhaler. Symptoms eased. 01-16-2021- felt better 01-17-2021- 5:00 pm- noticed onset of tightness in throat, feeling of something caught at back of throat and start of mucus drainage. Continued clearing of throat. Took 25 mg of benadryl and inhaler.
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| 41 | 2021-01-17 | vomiting |
COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had ch...
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COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had chest pain and sinus tachycardia. Received first COVID vaccine 12/18/20.Developed continuous vomiting 1.5 hours later then muscle aches and cramps as the day went on. Symptoms were gone later the next day except site soreness. Developed SOB and wheezing on 12/24/20. Went to ER - no treatment. Called her pulmonologist and increased diltiazem for the weekend. Called cardiologist 12/28/20 and was put on Corlanor. Took care of acute issues, but still had some SOB and palpitations.
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| 41 | 2021-01-17 | nausea, vomiting |
Fever of 102-103 F. Nausea, Vomiting, weakness, cough and post nasal drip. Inflammation of lymph nod...
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Fever of 102-103 F. Nausea, Vomiting, weakness, cough and post nasal drip. Inflammation of lymph nodes left upper extremity , head and neck. Began to feel difficulty swelling due to inflamed lymph nodes Treatment: Intravenous fluids, anti-inflammatory medication, sought treatment at an urgent care center. Ultrasound of left arm, axillary and neck and chest area for enlarged lymph nodes. Outcome- all symptoms resolved by 1/14 except some fatigue
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| 41 | 2021-01-17 | vomiting |
I became very weak, lethargic, vomiting, sore...flu like symptoms. Sent home. Lasted for two to thre...
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I became very weak, lethargic, vomiting, sore...flu like symptoms. Sent home. Lasted for two to three days. I was told that if symptoms got worse to go to ER, but they started getting better with time.
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| 41 | 2021-01-17 | vomiting, nausea |
I developed lightheadedness within 2 minutes of receiving covid 19 vaccine. I did not faint. I deve...
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I developed lightheadedness within 2 minutes of receiving covid 19 vaccine. I did not faint. I developed labored breathing around the same time as the lightheadedness. I was evaluated in the emergency room and diagnosed with a vasovagal event. The evening of the vaccine, I developed mild body aches, especially in the legs. The morning after the vaccine, I developed headache ,nausea and vomited once.
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| 41 | 2021-01-17 | abdominal distension |
tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloa...
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tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
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| 41 | 2021-01-18 | nausea | Body aches/fever/chills/headache/nausea. Arm soreness |
| 41 | 2021-01-18 | nausea, vomiting |
Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Sym...
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Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Symptoms gone by next day except residual site soreness. Asthma has worsened and is using Albuterol inhaler 1-2 times daily since second dose. Woke up 1/19/21 at 3am. Developed temperature then was diaphoretic. Vomited. Developed SOB, tachycardia, and wheezing.
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| 41 | 2021-01-18 | nausea | palpitations, chest heaviness, numbness in fingers and toes, fatigue, nausea lasting 1+ week |
| 41 | 2021-01-18 | nausea |
severe chills; severe nausea (no vomiting); headache; neck aches; This is a spontaneous report from ...
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severe chills; severe nausea (no vomiting); headache; neck aches; This is a spontaneous report from a contactable physician (reported for herself). A 41-year-old female patient (Pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el3248), via an unspecified route of administration on 10Jan2021 08:30 at single dose for COVID-19 immunization. The patient's medical history included Allergies to amoxicillin. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (lot number: ek9231) on 22Dec2020 21:45 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe chills, severe nausea (no vomiting), neck aches, headache on 10Jan2021 20:30. Treatment received for the adverse events included tylenol 1g x3 doses. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered in Jan2021.
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| 41 | 2021-01-19 | nausea |
Chills/sweats/fever/aches for about 5-6 hours. Then left with aches and mild headache. Occasional n...
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Chills/sweats/fever/aches for about 5-6 hours. Then left with aches and mild headache. Occasional nausea throughout the day and fatigue.
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| 41 | 2021-01-19 | diarrhea, nausea |
On Jan 12, the patient developed positional vertigo and nausea as well as sore arm. Vertigo resolve...
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On Jan 12, the patient developed positional vertigo and nausea as well as sore arm. Vertigo resolved when she fell asleep. Vertigo returned on Jan 16 and17. Diarrhea occurred 6 times on Jan 17. The patient noticed significant diffuse loss of hair from January 16 to 19. She continues to have some nausea.
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| 41 | 2021-01-19 | diarrhea |
at 6:00 pm I had diarrhea and the pain in my left arm started and I tooke tylenos 350mlg. I had a he...
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at 6:00 pm I had diarrhea and the pain in my left arm started and I tooke tylenos 350mlg. I had a headache in the middle of the night. today i woke up with a lot of pain non my left arm and shoulder and iI put Cbd pain cream all over my arm and tooke paracetamol 650 mlg for pain.
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| 41 | 2021-01-20 | difficulty swallowing |
Employee c/o fullness in throat with difficulty swallowing. No SOB. Given 25 mg of Benadryl IM. Symp...
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Employee c/o fullness in throat with difficulty swallowing. No SOB. Given 25 mg of Benadryl IM. Symptoms resolve within a half hour and patient was released to return to work
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| 41 | 2021-01-20 | vomiting, diarrhea |
I have had a severe headache since the day of vaccination, weakness, fatigue, dizziness, vomiting an...
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I have had a severe headache since the day of vaccination, weakness, fatigue, dizziness, vomiting and diarrhea.
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| 41 | 2021-01-20 | retching |
Sudden onset of tachycardia 220 beats, faint, week, sweating, clammy, hot, cold, dry heaving, feel...
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Sudden onset of tachycardia 220 beats, faint, week, sweating, clammy, hot, cold, dry heaving, feeling like going to pass out
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| 41 | 2021-01-20 | nausea |
general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spo...
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general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spontaneous report from a contactable consumer (patient's sister). A 41-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration on Jan2021 at the age of 41-year-old at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had no covid prior vaccination. Patient previously received first dose BNT162B2 on Dec2020 at single dose for covid-19 immunisation. She had received her second dose of vaccine and it "hit her like a bus", she experienced general body pain, migraine, nausea, and a low grade fever of 99 on Jan2021. Outcome of events was unknown. Information on lot/batch number has been requested.
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| 41 | 2021-01-21 | abdominal pain | I had eye pain and drainage, body aches, abdominal pain, headache and joint pain. |
| 41 | 2021-01-21 | nausea |
Immediate nausea and dizziness followed by increasing fatigue, brain fog and cognitive difficulties ...
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Immediate nausea and dizziness followed by increasing fatigue, brain fog and cognitive difficulties (I.e. driving and returning to work after) especially involving quick movements, tracking and concentrating. Moderate Arm soreness increased from the time of shot continuing beyond 24 hours and making it difficult to lift or move the arm
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| 41 | 2021-01-22 | vomiting, nausea |
About 17 hours after receiving the vaccination, I had vertigo. I woke up at 4:30 AM half an hour bef...
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About 17 hours after receiving the vaccination, I had vertigo. I woke up at 4:30 AM half an hour before my usual wake-up time, and the room was spinning and I had a headache. I had nausea at the time. I was unsteady for about 30-60 minutes, until I took Dramamine, which resolved the issue that day. Then about 24 hours after I received the vaccination, I developed chills and fatigue ( I didn't check by temp). I have been having vertigo daily and a headache upon waking up in the morning (today is 5 days post vaccination), and today, this was associated with an episode of emesis without nausea or abdominal pain. I did not have these issues previously.
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| 41 | 2021-01-22 | nausea, vomiting |
Nausea, vomiting, and body aches within 3 hrs of injection. Swelling and pain at injection site. Cel...
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Nausea, vomiting, and body aches within 3 hrs of injection. Swelling and pain at injection site. Cellulitis at injection site, L armpit, L breast, lymph nodes, L shoulder. Prescribed antibiotics and instructed to take OTC NSAIDS and Anti-hystamimes. If symptoms don't abade seek further treatment, possibly IV antibiotics.
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| 41 | 2021-01-23 | difficulty swallowing, nausea |
Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbe...
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Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.
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| 41 | 2021-01-24 | diarrhea |
Status post vaccine #2 Pfizer covid vaccine. R arm r preast started itching approx 7:45 . 8:16 T...
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Status post vaccine #2 Pfizer covid vaccine. R arm r preast started itching approx 7:45 . 8:16 Took own allegra, increased pruritis 8:40 called 9111 employee taken to clinic treated with benadryl and zyrtec, MD next day told to take allegra and Pepcid. 1/14 employee returned to work. Started Diarrhea on 1/15. Had intermittent diarrhea since then, still has pruritis. all over. Taking allegra and pepcid. benadryl at night. Employee Advised to contact allergist for appointment. Advised to contact MD again because of the persistent itching.
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| 41 | 2021-01-24 | difficulty swallowing |
This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immun...
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This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immunization, she appropriately stayed in the waiting area for the 30 minutes. She then got in car and 15 minutes after, she noticed that her tongue was feeling full/swollen and that was experiencing neck swelling. These symptoms persisted and resembled a prior allergic response to Tetracycline and Aleve. Wheezing and breathing difficulty ensued and EMS was activated. On arrival to the emergency department she was found to have wheezing with stridor. A dose of epinephrine was administered and she was monitored in the emergency department with an initial improvement in symptoms. Approximately one hour and 30 minutes after initial epinephrine administration patient reported that she was having continued difficulty swallowing and she was starting to feel a little worse. At this point a second dose of IM epinephrine was administered. The patient was subsequently admitted to inpatient medicine team for further monitoring.
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| 41 | 2021-01-24 | vomiting, nausea |
body aches, headache, nausea, vomiting, fever, chills, elevated pulse, generalized weakness and dizz...
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body aches, headache, nausea, vomiting, fever, chills, elevated pulse, generalized weakness and dizziness. Pain to left arm
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| 41 | 2021-01-24 | nausea |
following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose...
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following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose on 1/19/2021- swelling and pain at injection side, right axilla severe pain, flu like symptoms, nausea, headache. migrane developed on day 3, on day 4 hives and pruritus all over the body, swelling of hands and feet, on day 5 the symptoms worsened despite medicating with OTC benadryl 50mg every 6hrs. Contacted PCP and was prescribed prednisone 20mg daily with some improvement. day 6- today rash still present, pruritus present, weakness, dizziness, shaky. unable to work or drive.
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| 41 | 2021-01-25 | abdominal pain |
Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially ...
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Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially associate with the injection, 30 mins post injection after obs period I felt dizziness. Chills within an hour, accompanied by sweating. Continued to work through it because otherwise felt okay. Dizziness subsided shortly after additional antihistamine and Pepcid. Approximatley around 7 pm my face start burning and itching, I had a diffuse red rash all over my face and my torso. I took 50 mg of Benadryl and rash resolved. It was not hives, almost appeared as flushing, Over the weekend I had fevers, chills but nothing that prevented me from my daily life. I however, have felt since my 2nd vaccine throat irritation, and itching, sweating. I am just continue my Zyrtec and regimen I took several years ago when I had this type of immune response. I didn't bother with MD, I left a message with nurse.
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| 41 | 2021-01-25 | vomiting | Chills, body aches, vomiting |
| 41 | 2021-01-25 | decreased appetite |
Developed fever 100.4-101 lasting 48 hours. Extreme dizziness for 2 days to the point where I had di...
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Developed fever 100.4-101 lasting 48 hours. Extreme dizziness for 2 days to the point where I had difficulty standing. This lingered for an additional 3 days, but not as severe. Muscle pain especially in hips and back, weakness, fatigue, headache and loss of appetite.
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| 41 | 2021-01-26 | vomiting, diarrhea, nausea |
Fever; chills; body pains; headache; diarrhea; nausea; vomiting; weakness; This is a spontaneous rep...
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Fever; chills; body pains; headache; diarrhea; nausea; vomiting; weakness; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142, expiration date not reported) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin, shellfish, seafood. The patient's concomitant medications were not reported. The patient experienced fever, chills, body pains, headache followed by diarrhea, nausea, vomiting and weakness on 07Jan2021 10:00 pm. Treatment was received for the events (unspecified). The events resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included Nasal Swab on 09Jan2021: Negative. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 41 | 2021-01-26 | nausea | I had motion sickness , dizzy, and nausea. |
| 41 | 2021-01-26 | nausea |
headache runny nose Nausea severe muscle aches fever 102 degrees chills muscle fatigue shortness of ...
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headache runny nose Nausea severe muscle aches fever 102 degrees chills muscle fatigue shortness of breath cough congestion
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| 41 | 2021-01-26 | nausea |
seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss o...
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seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss of hearing; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; loss of the onion ability to stand up or walk; loss of the onion ability to stand up or walk; This is a spontaneous report from a contactable other health professional (patient), a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm on 14Jan2021 08:30 AM at single dose for covid-19 immunization in a public health facility. Medical history was none. Allergies to medications, food, or other products was No. Patient was not pregnant at the time of vaccination. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included amphetamine salts 15 mg. Patient woke up in the middle of the night got out of bed walk down a set of stairs started seeing gray spots room started spinning felt nauseous collapsed on the table. Had to call her husband to carry her back up the stairs. she had loss of vision loss of hearing and the onion ability to stand up or walk. He laid her back in bed to pick up his phone and call emergency services within five minutes everything had gone back to normal. adverse event start date was 15Jan2021 03:00 AM. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The final outcome of the events was unknown (if patient recovered: Unknown). It was reported as non-serious. Seriousness criteria Results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-26 | nausea, vomiting |
weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding...
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weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 41 | 2021-01-27 | decreased appetite |
All symtoms were for 45 hours Fever 102 Resting heart rate 125-130 Severe Headache Back Pain Chest p...
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All symtoms were for 45 hours Fever 102 Resting heart rate 125-130 Severe Headache Back Pain Chest pain on inspiration Mild shortness of breath Weakness Loss of appitite
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| 41 | 2021-01-27 | decreased appetite, nausea |
All the following symptoms lasted for 45 hours Fever 102, resting HR 125-130, severe headache, sever...
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All the following symptoms lasted for 45 hours Fever 102, resting HR 125-130, severe headache, severe back pain, muscle aches, chest pain on inspiration, weakness, mild nausea with loss of appitite.
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| 41 | 2021-01-28 | nausea |
"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove h...
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"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove home and at 4:00 p.m. face, forehead, and neck turned bright red, facial tightness, feeling like face was on fire. Heart rate recorded between 112bpm and 115 bpm and began having shortness of breath. Then began feeling nauseous, eyes were itchy and had a headache. Took 10 ml Benedryl @ 4:40 p.m. and drank some water. 7:00 p.m. still have slight facial and neck redness and headache.
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| 41 | 2021-01-28 | abdominal pain |
245 pm Rash on lower arm 600 chills 700 leg cramps significant to make muscle fasciculations 900 bow...
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245 pm Rash on lower arm 600 chills 700 leg cramps significant to make muscle fasciculations 900 bowel dysfunction Following day, flu like symptoms, chills, aches, etc Rash still has not gone away I have had abdominal cramping and significant pain. It has worsened to resemble the pain I had prior to my hysterectomy and endometriosis ablation/scar tissue removal.
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| 41 | 2021-01-28 | nausea |
It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches a...
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It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches and pain and a little trouble breathing. They started to subside four days after vaccine was administered.
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| 41 | 2021-01-28 | vomiting, nausea |
Saturday morning. Whole body aches and chills. Severe headache all day. Nausea and eventually vomiti...
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Saturday morning. Whole body aches and chills. Severe headache all day. Nausea and eventually vomiting twice in the evening. Very exhausted. Tried tylenol, cold packs, hot packs, ginger ale - none were helpful. Took long hot shower and bath after vomiting and felt a little relief. These symptoms lasted 12 hours or so and then I felt fine besides being exhausted. By Sunday evening I was completely back to normal.
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| 41 | 2021-01-28 | nausea |
This is a spontaneous report from a contactable consumer. A 41-year-old female patient received her ...
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This is a spontaneous report from a contactable consumer. A 41-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) on her left arm, via an unspecified route of administration on 08Jan2021 11:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included spironolactone, loratadine (CLARITIN) and fish oil. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (first dose). The patient experienced severe chills with body shaking for 6 hours, excruciating headache, fever, sore throat, nausea and excessively high resting heart rate (over 100- usually under 60); all on 08Jan2021 20:30. No treatment was received for the events. The outcome of the events was recovered on 09Jan2021 02:30.
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| 41 | 2021-01-29 | abdominal pain, decreased appetite |
Elevated blood pressure, fever, malaise, headache, dizziness, loss of appetite, abdominal pain. all ...
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Elevated blood pressure, fever, malaise, headache, dizziness, loss of appetite, abdominal pain. all of these symptoms came on gradually and worsened 20 hrs after vaccination. symptoms lasted a full 48hrs for me and slowly dissipated over the following days. Itching at injection site started 72hrs after and has now ceased
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| 41 | 2021-01-29 | nausea | Severe chills, sweating, low grade fever, nausea, dizziness, headache |
| 41 | 2021-01-30 | vomiting |
Fever and chills, fatigue, body aches, headache, weakness, vomiting, pain at injection site and back...
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Fever and chills, fatigue, body aches, headache, weakness, vomiting, pain at injection site and back pain, joint pain, that started approximately 10 hours post injection and lasted for approximately 36 hours.
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| 41 | 2021-01-30 | abdominal pain upper, diarrhea | diarrhea and stomach cramping |
| 41 | 2021-01-31 | difficulty swallowing |
Allergic reaction; Throat swelling; tightness; difficulty swallowing; This is a spontaneous report f...
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Allergic reaction; Throat swelling; tightness; difficulty swallowing; This is a spontaneous report from a contactable Other Health Professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. The patient medical history reported no current heath issue like no "acute" (not clarified) current she got but she had got "bulging" (not clarified) disc and "effects" in the past, no "aplasia" (not clarified) nothing, no and she was "marina" (not clarified)." There were no concomitant medications. The reporter reported a patient that had an allergic reaction to the Pfizer Covid vaccine. Nurse stated that when she was "admitted" (not clarified) she was in the ER being monitored she got "admitted" (not clarified) first day today 7:45 not clarified (15Jan2021). The patient experienced allergic reaction, included "Throat swelling, tightness, difficulty swallowing." The reporter gave the patient "Api" (not clarified) 0.3 milligram and then also she had "Dimedrol" (not clarified) 125 and then she had CAPCID 20mg IV "piggy back" (not clarified). She had Benadryl 50 milligrams." The outcome of the events was unknown. Information on the batch number and lot number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of allergic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-01-31 | nausea | Fever, Nausea, Body Aches, Headache |
| 41 | 2021-01-31 | nausea, vomiting |
Starting the day after the injection she began having a fever as high as 102.4, severe chills, joint...
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Starting the day after the injection she began having a fever as high as 102.4, severe chills, joint pain, headache, nausea, vomiting, body aches
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| 41 | 2021-01-31 | abdominal pain |
Two hours post injection, developed numbness, tingling, extreme cold in hands and feet with fatigue....
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Two hours post injection, developed numbness, tingling, extreme cold in hands and feet with fatigue. Slept for 3 hours, awoke feeling better. 14 hours post injection developed severe body aches, chills, fever, numbness in hands and feet, severe abdominal pain and cramping, and a rash on arms and abdomen.
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| 41 | 2021-01-31 | abdominal discomfort |
have limited use in my L hand; numbness down the L side of my body into my L foot; experiencing a ma...
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have limited use in my L hand; numbness down the L side of my body into my L foot; experiencing a major flare-up of my condition; low-grade fever (between 99-100); severe muscle & joint pain; severe muscle & joint pain; existing nerve impingement affecting the left (L) side of my body & both sides of my face; decreased concentration & executive functioning; GI upset; anticipated some inflammation response to the vaccine; feel sick; This is a spontaneous report from a contactable other-HCP (patient). A 41-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 30Dec2020 at 18:00 at single dose in right arm for covid-19 immunization. Medical history included Ehlers-Danlos syndrome hypermobility type, IgA deficiency, cervical radiculopathy, spondylosis of cervical region, chronic hypertension, fibromyalgia, androgenic alopecia, seasonal allergies, and known allergies: gold, nickel. The patient's concomitant medications were not reported. The patient previously took prednisone and experienced allergies. The patient reported that she anticipated some inflammation response to the vaccine from 04Jan2021. Briefly, she started to feel sick around 04Jan2021, by 10Jan2021 was experiencing a major flare-up of her condition requiring additional medication and time off from work. She had had a low-grade fever (between 99-100) from 04Jan2021 for 7 days, severe muscle and joint pain from 04Jan2021. She had existing nerve impingement affecting the left (L) side of her body and both sides of her face from 04Jan2021. Beginning 12Jan2021 she had limited use in her L hand, numbness down the L side of her body into her L foot. This was most likely due to significantly increased levels of inflammation as a result of the vaccine. She had also had GI upset, decreased concentration & executive functioning from 04Jan2021. It was unknown if the patient received treatment for the events. The outcome of the events was not resolved. The events resulted in doctor or other healthcare professional office/clinic visit.
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| 41 | 2021-02-01 | nausea |
high platelets; fatigue; sharp muscle pains in hands and elbows; Headaches; nausea; Canker sore on m...
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high platelets; fatigue; sharp muscle pains in hands and elbows; Headaches; nausea; Canker sore on my tongue; had a sizable bruise; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 09Jan2021 11:45 AM at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient is not pregnant. Patient previously took the first dose of BNT162B2 at single dose for COVID-19 immunization. Patient have had a lot of fatigue, sharp muscle pains in hands and elbows at day 9 post injection (17Jan2021). Patient was now developing a Canker sore on her tongue as a fellow coworker had the same reaction (Jan2021). Patient have high platelets and have had a sizable bruise for 9 days. Headaches and nausea were present at three hours post injection (09Jan2021). AE resulted in doctor or other healthcare professional office/clinic visit. No COVID prior vaccination. No COVID tested post vaccination. covid test type post vaccination included Nasal Swab on 12Jan2021 with test result of Negative. No treatment received for the events. Outcome of the events was unknown. Information on the Lot/batch number has been requested.
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| 41 | 2021-02-03 | vomiting, nausea |
Both times I received the vaccine on the third day I my migraine was triggered and I experienced se...
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Both times I received the vaccine on the third day I my migraine was triggered and I experienced severe migraines, nausea and vomiting with extreme pain and sensitivity to light and sound. I also experienced severe body pain after both shots. I did not see my physician who I listed but she has notes about my history or migraines. It was suggested on the CDC tracking app to report here too since my reactions were severe.
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| 41 | 2021-02-03 | decreased appetite |
Pt. stated that she received the COVID vaccine on 1/20/21. On 1/21/21 she felt tired, had loss of a...
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Pt. stated that she received the COVID vaccine on 1/20/21. On 1/21/21 she felt tired, had loss of appetite. She reported that she went to a store, and apparently "passed out." Employees of the store told her that she had a seizure. Pt. was transported to local ER, where she states that she had a CT of brain, blood work and was told "everything is normal." Stated that she had COVID testing both in the ER and at work, both reportedly negative. This clinic, has thus far been unable to obtain the individuals medical records from the ER. When seen in our clinic on 2/3/21, pt. stated that she is feeling better, but fatigued. No other loss of consciousness reported by pt.
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| 41 | 2021-02-04 | nausea |
Soreness of arm ,The following day I woke up and felt fine and cup of coffer I felt nauseated , head...
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Soreness of arm ,The following day I woke up and felt fine and cup of coffer I felt nauseated , headache, Took Advil and headache was worse.. The following day I still had a really bad headache and felt nauseated .
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| 41 | 2021-02-04 | nausea |
Temporary nausea, significant fatigue, Muscle pain, Joint pain Redness, pain and swelling still rem...
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Temporary nausea, significant fatigue, Muscle pain, Joint pain Redness, pain and swelling still remains at site of injection Pain on top of head, but not necessarily a fullbown headache
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| 41 | 2021-02-04 | diarrhea, vomiting |
pt states that she started running fever 99.8 with chills, headache, body aches, vomiting and diarr...
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pt states that she started running fever 99.8 with chills, headache, body aches, vomiting and diarrhea later on the day of the vax. Next day she only had body aches. She stated that today 2/5/2021 she has body aches, headache and dizziness. Pt has not contacted her PCP at this time.
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| 41 | 2021-02-05 | nausea, vomiting |
After receiving 2nd dose of vaccine on 1-25-2021 at 11:20, I had spiked a fever of 104.00, nausea, b...
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After receiving 2nd dose of vaccine on 1-25-2021 at 11:20, I had spiked a fever of 104.00, nausea, body chills, lethargy, vomiting, head ache and arm pain. Took 50 hours to get out of bed and feel half normal. Thought I was on the road to recovery when the arm pain started to increase. No rash or swelling occurred at the sight. It presents with pain more nerve like pain in my shoulder, elbow and radiated to fingers. On Feb 5th the pain was so bad I went to see a shoulder specialist and are trying to figure out what is going on. My right arm remains painful to move with nerve issues. The specialist advise I report. In the meantime, I will follow up Monday with another specialist and also undergo some nerve testing.
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| 41 | 2021-02-08 | nausea |
I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness a...
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I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.
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| 41 | 2021-02-16 | nausea, vomiting |
Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; ...
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Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-02-17 | nausea |
trouble lifting my arm; Pain in arm; Nauseous; Chills; Urge to cry; This is a spontaneous report fro...
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trouble lifting my arm; Pain in arm; Nauseous; Chills; Urge to cry; This is a spontaneous report from a contactable consumer who reported for herself . This 41-years-old no pregnant female patient received first dose of bnt162b2 (BNT162B2) from LOT# E19262, on 03Feb2021 17:30 on right arm at SINGLE DOSE for covid-19 immunisation .Age at vaccination:41 years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine . The patient received other medications within 2 weeks of vaccination .Medical history included :Allergy to adhesive, ADHD, high blood pressure (HBP), depression, anxiety, gerd. On 04Feb2021 20:00 the patient experienced chills, urge to cry, trouble lifting in arm , pain in arm and she was Nauseous. Events reported as non serious .No treatment received. Outcome was not recovered. Prior to vaccination the patient was not diagnosed with COVID-19Since the vaccination, the patient has not been tested for COVID-19
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| 41 | 2021-02-22 | nausea, diarrhea |
Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache....
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Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.
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| 41 | 2021-02-22 | nausea |
Started with achiness just before midnight (after having sore arm all day, but not troubling), woke ...
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Started with achiness just before midnight (after having sore arm all day, but not troubling), woke with fever/chills/headache about 1am and unable to sleep well 1-6am, slight nausea 4-8am, still ongoing achiness all over body and just ill-feeling and fatigue (currently 11am day-after vaccine)
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| 41 | 2021-02-22 | vomiting | Vomiting fainting fever |
| 41 | 2021-02-22 | nausea |
Woke at 3am with severe body aches, headache, fever of 101.3 and nausea. Symptoms persisted througho...
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Woke at 3am with severe body aches, headache, fever of 101.3 and nausea. Symptoms persisted throughout the day with max temp of 103. Also had swelling at injection site with redness the size of a baseball and extreme tenderness to upper arm.
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| 41 | 2021-02-24 | diarrhea |
On 1/12/2021 around 2 am I started feeling, chills, body aches, headaches, diarrhea & fatigue. They ...
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On 1/12/2021 around 2 am I started feeling, chills, body aches, headaches, diarrhea & fatigue. They lasted 50 48-72 hours. I took Tylenol for my symptoms. I did have Covid-19 on May 2020.
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| 41 | 2021-02-27 | nausea |
Numbness in tongue and lips six hours after taking the vaccine. I took a Benadryl and the symptoms s...
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Numbness in tongue and lips six hours after taking the vaccine. I took a Benadryl and the symptoms subsided after 60 minutes. I also experienced dizziness and weakness right after taking the vaccine, which lasted for 24 hours. Other symptoms include tiredness, headache, muscle pain, chills, low-grade fever, and nausea, which have lasted for 24 hours and continue now.
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| 41 | 2021-02-28 | vomiting, abdominal pain |
About 16 hours after shot some soreness/pain up my spine, still could do daily activities- took some...
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About 16 hours after shot some soreness/pain up my spine, still could do daily activities- took some ibuprofen as needed. But after 24 hours abdominal pain, still able to do daily activities but during that evening's sleep the pain went up and felt like the early stages of labor through till the morning-- then I took ibuprofen. This abdominal cramping was steady in the night and did not easy for many hours and caused me to vomit. Due to pain and vomiting I was not able to go in to work for the day but was able to recover by lunch time with ibuprofen and rest and so I could return to work the following day.
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| 41 | 2021-02-28 | vomiting |
Friday at 4pm I experience severe unquenchable thirst and mild injection site soreness. Saturday mor...
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Friday at 4pm I experience severe unquenchable thirst and mild injection site soreness. Saturday morning was restless sleep and headache with severe joint pain and thirst. All Saturday same. Skin hurt to touch and knees and finger knuckles hurt to touch. Vomiting. Throbbing injection arm pain and the urge to constantly stretch all limbs. Sunday all subsided except the throbbing arm pain. Sunday evening at 8 pm throbbing arm worse and headache. Monday 3am restless sleep and miserable comfortableness. Throbbing arm and restless painful shockwaves through entire body. Skin severely hurt to touch. Went to the ER. Treated with Atavan and prescription Motrin.
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| 41 | 2021-02-28 | vomiting, diarrhea |
Headache daily in the morning. On 2/26/21 developed a migraine with vomiting and went to ER. Today o...
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Headache daily in the morning. On 2/26/21 developed a migraine with vomiting and went to ER. Today on 3/1/21 continues to have headache every morning but not as severe and today has had 3 loose, watery stools.
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| 41 | 2021-02-28 | diarrhea |
MRI showing inflammatory lesion of the Pons/Single lesion appearing inflammatory in nature found in ...
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MRI showing inflammatory lesion of the Pons/Single lesion appearing inflammatory in nature found in the pons at origin of cranial nerve 6; single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6; Development of double vision/double vision with right gaze and head turning; mild chills; headache; significant diarrhea; vision noted to be off; This is a spontaneous report from a contactable other health care professional, the patient. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 14Jan2021 at 01:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included spontaneous coronary artery dissection with stenting (reported as "five years ago") and complex migraines from an unspecified date. The patient is allergic to Tramadol, Codeine and Novocaine. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899) on 23Dec2020 at 01:15 AM as a single dose in the left arm for COVID-19 immunization.The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diltiazem (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN).The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported the development of double vision on 25Jan2021 at 06:00. She was hospitalized and remained hospitalized for three days. She reports having had an MRI (date not specified) which showed an inflammatory lesion of the Pons. She further described the events as follows: Initially mild chills and headache "the day after" developing into significant diarrhea for four days and on and off diarrhea for several weeks. One week after vaccine vision noted to be off but no official work up developing into double vision with right gaze and head turning three weeks after vaccine. She also stated that there was a single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6. Treatment received included Solumedrol and Pepcid infusion. Lab data included an MRI on an unspecified date which showed inflammatory lesion of the Pons and COVD-19 testing as follows: SARS-CoV-2 Nasal Swab PCR test on 20Jan2021 and on 11Feb2021 both of which were negative. The clinical outcomes of brain inflammation, double vision, chills, headache, diarrhea, vision decreased and cranial nerve disorder were reported as recovering. No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-02-28 | nausea |
fever (102.3), sore arm, sore arm pits, headache, brain fog, chills, body ache, food aversion, nause...
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fever (102.3), sore arm, sore arm pits, headache, brain fog, chills, body ache, food aversion, nausea, fatigue
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| 41 | 2021-03-01 | abdominal pain, nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vac...
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Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.
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| 41 | 2021-03-02 | decreased appetite |
Fever last night of 102.3; cold chills; aches; extreme fatigue; loss of appetite; This is a spontane...
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Fever last night of 102.3; cold chills; aches; extreme fatigue; loss of appetite; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 24Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included valaciclovir hydrochloride (VALTREX). The patient previously took acetylsalicylic acid (ASPIRIN) and hydrocododone and experienced allergies. The patient experienced cold chills and aches, extreme fatigue, loss of appetite on 26Jan2021 10:00 AM. At days 5-7, my symptoms went from to strongly moderate. Fever last night (30Jan2021) of 102.3. No treatment was received for the events. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 41 | 2021-03-02 | nausea |
Shakes, chills, mild temperature (100), insomnia, nausea, exhausted, weak. Entire left side hurt, l...
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Shakes, chills, mild temperature (100), insomnia, nausea, exhausted, weak. Entire left side hurt, lymph node under arm - near breast on side of vaccination swollen for 4 days. Headache Onset of chills began at 1am. Around 5am I started shaking and nauseous and I had not been able to fall back to sleep. 5am 2/25 until I woke up for the day 2/26 at 6am, I had the nausea, chills, weak. Lymph node swollen stayed for 4 days. I felt very confused, like I couldn't hold a full thought. No reaction to 1st vaccine except a sore arm
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| 41 | 2021-03-02 | difficulty swallowing |
Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. o...
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Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. onset within 30 minutes of vaccines. taken to Urgent care, received epinephrine injection, then transferred by ambulance to Hospital ER. given IV diphenhydramine and IV decadron. chest pain. normal ECG and troponin. They did not check tryptase.
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| 41 | 2021-03-02 | nausea |
face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really...
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face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.
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| 41 | 2021-03-03 | nausea |
After receiving the vaccine, patient experienced nausea with an episode of syncope. SBP 60 mmHg prio...
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After receiving the vaccine, patient experienced nausea with an episode of syncope. SBP 60 mmHg prior to syncope. Patient was given epinephrine 0.3 mg IM x1 dose. Patient was difficult to arouse and a second epinephrine 0.3 mg IM was administered! EMS was called on seen and patient was taken to the ER where patient received fluids and zofran and was discharged. Husband confirmed the patient has phobia for shot/needles.
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| 41 | 2021-03-04 | nausea |
About an hour after the Covid vaccine was given I experienced heart racing very rapidly, wave of nau...
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About an hour after the Covid vaccine was given I experienced heart racing very rapidly, wave of nausea, feeling faint, knot in throat, this last about 5-10 minutes then passed, had knot in throat x 2 days.
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| 41 | 2021-03-04 | difficulty swallowing |
Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes th...
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Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes there was an increasing feeling of throat tightness. It started on the right side of throat, then the left a few minutes later. Eventually a feeling of pressure behind eardrums and a little trouble swallowing. Epi was given approximately 20 minutes after vaccine was administered, then a dose of Benadryl. Paramedics were called, transported to ED for observation for 4 hours. Symptom of tightness in throat improved within minutes of Epi, returned after a few hours with less severity. That feeling took a few days to completely subside.
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| 41 | 2021-03-04 | nausea |
Progress Notes (Nurse Practitioner) Pt called to follow up s/p covid-19 vaccine done on 02/24/21....
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Progress Notes (Nurse Practitioner) Pt called to follow up s/p covid-19 vaccine done on 02/24/21. She reports she took a nap yesterday after getting home and felt better afterwards. Today she feels well. Denies any other questions or concerns. She is appreciative of the phone call. Progress Notes at 2/28/2021 7:34 AM Expand AllCollapse All VACCINE CLINIC 2/24/2021 Subjective Patient is a 41 y.o. female who was seen at SVH COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness, headache, nausea, tingling lips and a metallic taste in her mouth. She denied rash, difficulty breathing, difficulty swallowing, throat tightness, facial swelling and lip swelling. She does mention having a history of anxiety and did take her duloxetine and Wellbutrin today. Denies use of her Ativan recently. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness and headaches Patient denies chills, facial swelling, chest tightness, shortness of breath and wheezing +nausea and metallic taste in mouth: Previous Reactions: Denies Objective Vitals Vitals: 02/24/21 1427 02/24/21 1434 BP: 126/70 112/68 Pulse: 81 80 SpO2: 99% 96% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: Tylenol and water Follow up response to treatment: good. She noted some lightheadedness prior to discharge but other symptoms were improved. I walked patient around the bay area and she was feeling okay. Her vitals were stable. Pt was escorted out of the facility. Patient discharge: Stable to go home and follow up with PCP. Electronically Signed 2/24/2021 2:43 PM
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| 41 | 2021-03-07 | nausea, vomiting | Extreme Migraine, nausea, puking, |
| 41 | 2021-03-07 | nausea, abdominal pain upper, diarrhea |
Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; swea...
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Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given), the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
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| 41 | 2021-03-17 | nausea |
sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough;...
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sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 07Jan2021, 15:00 (lot number: EL3246), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in the hospital. The patient's medical history included Covid-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient experienced sore throat, nausea, palpitations, headaches, dizziness, fatigue, faint, cough, body aches and myalgia on 08Jan2021, 19:00. The adverse events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient received treatment including antibiotics (did not help); pain medications for myalgia. The patient was underwent COVID-19 (Nasal Swab) on 15Jan2021 which was negative, and PCR and Flu (nasal swab) test on 20Jan2021 which was negative. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 41 | 2021-03-31 | abdominal pain |
Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sens...
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Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM. Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.
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| 41 | 2021-04-12 | abdominal pain, appendicitis |
Developed abdominal pain 4/7. Diagnosed with acute appendicitis 4/9 and underwent laparoscopic appen...
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Developed abdominal pain 4/7. Diagnosed with acute appendicitis 4/9 and underwent laparoscopic appendectomy 4/9. Also incidentally noted to have complex cystic pancreatic tail mass up to 8.3 cm with 7mm and 4mm RLL subsolid lung nodules. Patient has been discharged after appendectomy, and further workup of the pancreatic mass is planned. The appendicitis AE is resolved, but the pancreatic mass and lung nodules (likely not related to vaccine) are ongoing at this time.
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| 41 | 2021-04-19 | nausea |
Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that...
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Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that went up to 102.1 followed by chills and body ache, light headed ness and headache. Rashes occurred 10-12hrs after vaccine and got worse till was treated at a medical clinic and er. Had heavy heart rate of 120+ IV administered with diphenhydramine which is continued even now as slight rashes still exists and prednisone was given on Sunday April 19 2021 at 11:50am Later since rashes still persisted was advised by the urgent clinic to go to ER where hydroxyzine was given
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| 41 | 2021-04-21 | nausea |
- Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -...
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- Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -Rapid heartbeat 5-10 minutes after injection, along with dizziness, rapid pulse and nausea that lasted approximately 5 minutes -After than, body aches, nausea, arm pain and tiredness -Nausea, exhaustion, arm pain and body aches for 48 hours following injection -Started monthly period early, 4 days following vaccine, period started heavier than normal (started my period 1 week early which is VERY unusual for me) -Some of my vaccine reactions felt exactly like a condensed and much stronger version of PMS
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| 41 | 2021-04-24 | nausea |
Fainting; Nausea; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (Pati...
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Fainting; Nausea; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Lot number: EW0162) via unspecified route of administration on arm left at a single dose on 08Apr2021 17:00 for COVID-19 immunization. The patient medical history. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Apr2021 at 17:15 patient experienced nausea, fainting, dizziness and fatigue. The outcome of the events was recovered on an unspecified 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 41 | 2021-04-24 | nausea |
hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme majo...
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hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme major; I broke out with multiple sores all over the left Breast; a strange Blister was on my left breast; Pain; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient has no medical history. Concomitant medication(s) included alprazolam (XANAX). On 08Mar2021 21:00, the patient became sick 11 hours after first dose and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left Breast and still am and was diagnosed with Erythema multiforme major from an autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then, I started bleeding again only 14 days after my period ended again. The pain and bleeding are as intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021 covid test type post vaccination=Nasal Swab, covid Test name post vaccination=Pi xel by lab, covid test date=31Mar2021, covid test result=Negative. The patient did not receive treatment for the events. The outcome of the events hemorraging, Erythema multiforme major, I broke out with multiple sores all over the left Breast, a strange Blister was on my left breast was not recovered, while recovering for the events nausea, fatigue, and headache, and unknown for the rest of the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. I was in good health before receiving the vaccine and never had skin issues or irregular or painful periods with this much bleeding.
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| 41 | 2021-04-27 | decreased appetite |
asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic react...
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asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic reaction; felt itching of her throat; fingertip started turning purple; coughing a lot; hard time breathing; hot feeling around her arms and left side of body; it has been three days since she has been really sick; she is easily tired.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 21Mar2021 around 16:15 (Batch/Lot Number: ER2613) (at the age of 41-year-old) as single dose for covid-19 immunisation. Medical history included allergic to shellfish, ongoing systemic scleroderma, ongoing raynaud's syndrome (6 years ago) and interstitial lung disease (6 years ago). Concomitant medications included amlodipine besilate (NORVASC), at 5mg three times a day, prednisone (MANUFACTURER UNKNOWN) via oral at 5mg once a day; mycophenolate mofetil (CELLCEPT) at 1000 mg twice a day, hydroxychloroquine phosphate (PLAQUENIL) at 200mg twice a day, omeprazole (PROTONIX) at 40mg twice a day, sildenafil citrate (MANUFACTURER UNKNOWN) at 20mg three times a day, atorvastatin (LIPITOR) at 40mg once a day, gabapentin (MANUFACTURER UNKNOWN) at 300mg once a day; all are ongoing and taken for systemic scleroderma. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect was none. On 21Mar2021, the patient experienced anaphylactic reaction and was rushed into to the emergency room after 25 minutes of receiving the vaccine. The patient stated she called the CDC they recommend not to take vaccine of the second dose. The patient stated now she just called and it has been three days since she has been really sick and they told her to call us because doctor at the emergency room at the hospital and specialist because she has an underlying disease (Scleroderma) and told her to double check if she does not take booster of Pfizer vaccine what is the effect in her body? patient stated they are giving her advice that if she does not take it can she can take the J&J. The patient explained after she was administered the vaccine, she went to the waiting area where they told her she should be held for 30 minutes then in about 15 minutes she started getting a hot feeling around her arms and left side of her body so she took off her sweater thinking that would make her comfortable because she was uncomfortable. The patient stated 25 minutes after sitting there the nurse asked if she was ok, so she went out for fresh air that day it was not hot in the hospital but the temperature was around 60 on Sunday so it was really nice weather and she went outside for a fresh breath of air for 5 minutes, stayed took off mask, and felt relieved. The patient went back inside of the room and felt itching of her throat, 25 minutes receiving the vaccine and it stopped when she received the epi pen. The patient stated she thinks she recovered from because since Sunday she has had different effects. Then coughing started 25 minutes so probably roughly around 4:45pm on 21Mar2021 and stated when they administered epi pen not sure time but probably after an hour was when she was reviving in the ER. The patient experienced fingertip started turning purple and this started 30 to 45 minutes when she was rushed to emergency room and because of everything going on she does not remember when it stopped. The patient stated the doctor gave her a shot of epi pen and hooked her up. They did a lot of things in the emergency room that she does not remember. She only remembers her whole hand was purple and they gave her the epi shot. The doctor asked does she know what he was holding, she responded an epi pen, and the doctor said yes. She confirmed she has never used an epi pen before since she has not had any other allergic life-threatening reaction from a vaccine. The doctor said he was going to administer it right now because she cannot breathe. At this time, she was conscious and had a hard time breathing, but was listening. The doctor administered the shot and the hard time breathing and coughing stopped like 30 seconds after. However, she is still having a hard time to breathe. The patient stated the purple hands probably wore off after an hour but since she has Raynaud's disease it was hard for her to recover from circulation of oxygen in body. The patient had hard time breathing because Tuesday she still felt like asthma attack so around Tuesday still having hard time of breathing and still coughing a lot. The patient stated on Wednesday (on 24Mar2021) coughing was regulated a little bit and every time she was walking, she would cough. The patient commented she was discharged from the hospital Sunday. Later confirmed she was not actually admitted, just in the emergency room. The patient stated after the anaphylaxis reaction she was discharged at 9:30 in the evening and the following day she emailed her specialists and then replied and gave her advice that they could give and that she needed to call CDC vaccine and then they check on her. The patient confirmed she did actually go to her physician's office. On 22Mar2021, the patient felt weak she was lying in her house the whole Monday and lying-in bed week and had no appetite. The patient had an asthmatic reaction on Tuesday (on 23Mar2021), like hard time breathing, and she called her pulmonologist, and it was not like emergency and she knows that because she has an underlying lung disease, so she used nebulizer every 6 hours and also used inhaler albuterol inhaler. The patient had hard time walking and stated on Monday and Tuesday she did not get up from bed only just to go to the bathroom and to clean herself but yesterday she started walking around the house and it was hard for her because she was still coughing but today, she was walking already. The patient stated yesterday she was ok but had a hard time if walking it was hard for her to get up from bed and she can walk but she is easily tired. The patient underwent lab tests and procedures which included CT exam as part of her diagnosis for medical condition on an unspecified date and results are unknown. The patient stated she did not have an exam in the emergency room. Therapeutic measures were taken as a result of events anaphylactic reaction, felt itching of her throat, coughing a lot, fingertip started turning purple, hard time breathing, asthmatic reaction like hard time breathing included Epi Pen, Benadryl, she had an IV and the medicine administered through IV was a steroid combination of Benadryl pepa something, and stated she did not know the spelling, but it was a steroid mix that she received in the emergency room. The patient stated when she was home, on Tuesday, she had taken a nebulizer albuterol every 6 hours. She mentioned she just took Tylenol one time Tuesday night because she felt she was getting a fever. Her temperature was 99, not yet fever, but temperature was 99. The outcome of the events asthmatic reaction like hard time breathing was recovered on 24Mar2021, it has been three days since she has been really sick and she is easily tired was unknown and all other events were recovering. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
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| 41 | 2021-04-28 | nausea |
Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing lo...
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Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing loudly; Pale; Vasovagal response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), on the left arm on 14Apr2021 (15:15) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, allergies and sulfa allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID). On 13Apr2021 (15:15), the patient had a feeling of blacking out; nauseous/nausea; light headed; vision was clouded over; ears had started ringing loudly; was pale; and had vasovagal response. The events had resulted in doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care. The patient had received an anti-nausea medication, fluids and antacids as treatment for the reported events. The patient's bloodwork was fine and vitals were good, both on 13Apr2021. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.
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| 42 | 2020-12-31 | nausea |
Dizziness, nausea, diaphoresis, syncope/fall. Totally blacked out and fell. Helped back to bed, co...
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Dizziness, nausea, diaphoresis, syncope/fall. Totally blacked out and fell. Helped back to bed, covered in sweat. No fever. Layed in bed until next morning around 10am, still dizzy and nauseated.
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| 42 | 2021-01-01 | nausea |
pfizer-Biotech/Covid-19 vaccine flu like symptoms- nausea, light headed, trouble focusing, stuffy n...
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pfizer-Biotech/Covid-19 vaccine flu like symptoms- nausea, light headed, trouble focusing, stuffy nose, body aches, fever and chills but no actual fever- body just felt really warm. problems breathing at times (like a panic attack), headache, stiff neck, fatigue-- I fell asleep in my car because I was so tired. sore arm, irritability, When trying to lie down, I could not get comfortable, I found myself lying on the floor since it was cold, this is not normal behavior. i felt super sick. I was crawling on the floor because of how dizzy and tired i felt. It felt like a really bad drunk or hangover. noises were too loud, it felt horrible. I don't know if it is done.
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| 42 | 2021-01-03 | nausea |
Few minutes after receiving the vaccine I have noticed slight shortness of breath, then after 45 min...
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Few minutes after receiving the vaccine I have noticed slight shortness of breath, then after 45 minutes, I developed a headache. These symptoms worsen as the day progressed. The severe headache and increased shortness of breath lasted 14 days along with dangerously elevated blood pressure, fatigue, and nausea.
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| 42 | 2021-01-03 | vomiting, nausea |
Nausea ,vomiting 48hrs fever 101 maxing out on Tylenol . Body aches Lethargy, Chills. Sore arm. To...
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Nausea ,vomiting 48hrs fever 101 maxing out on Tylenol . Body aches Lethargy, Chills. Sore arm. Took anti nausea meds for 4 days.
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| 42 | 2021-01-03 | vomiting, nausea | Nausea, Vomiting, extreme fatigue, dizzyness |
| 42 | 2021-01-04 | difficulty swallowing |
About 20-30 after injection it became a bit difficult to swallow. Throat felt thicker; heart felt li...
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About 20-30 after injection it became a bit difficult to swallow. Throat felt thicker; heart felt like it was racing. Shivering and Blood pressure was up a little. 14:19 Benadryl 25 mg administered. 14:30 BP 164/92, P-76 R-16 O2 100% Discharged back to work at 16:15.
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| 42 | 2021-01-04 | abdominal discomfort |
About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI...
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About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 28Dec2020 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included the patient had allergies to medications, food, or other products, Bactrim and Sulfa based medications, & food sensitivities. Concomitant medication included birth control. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergies to medications: BACTRIM. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28Dec2020 About 45 minutes after injection, patient got a bloody nose out of nowhere (14:00), then at night at 22:00 (10:00PM) started having gastrointestinal (GI) symptoms & low grade fever. The events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever. Outcome of the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever were recovering. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 42 | 2021-01-04 | nausea |
Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizz...
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Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizziness. The next the morning, she had headache, nausea and strange feeling on the tip of throat and nose. She also had pain and swelling in the injection side, no erythema.
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| 42 | 2021-01-04 | abdominal pain |
Employee received the COVID vaccine on 12/23. She developed abdominal pain on 12/29. Was seen in t...
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Employee received the COVID vaccine on 12/23. She developed abdominal pain on 12/29. Was seen in the ED on 12/30 for an emergency appendectomy. Employee states that the CDC website lists appendectomy as the most common severe adverse event in the COVID vaccine group. Which was numerically higher than in the placebo group.
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| 42 | 2021-01-04 | vomiting, nausea |
Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site ...
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Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site with paresthesias in the lower arm; neck pain on the injection side; severe fatigue; myalgia; Fever; chills; SOB on exertion; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old female patient received 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), via an unspecified route of administration at arm left, on 18Dec2020 at 02:30 PM, at single dose, for COVID-19 immunisation. Medical history included hypertension, obesity, mood disorder, latex allergy. Patient did not experience COVID-19 before vaccination. Concomitant medications included trazodone (unknown manufacturer), escitalopram (unknown manufacturer). On 18Dec2020 at 10:00 PM the patient experienced nausea with outcome of recovering, vomiting with outcome of recovering, pain at injection site with paresthesias with outcome of recovering, neck pain on the injection side with outcome of recovering, severe fatigue with outcome of recovering, myalgia with outcome of recovering, fever with outcome of recovering, chills with outcome of recovering, shortness of breath (SOB) on exertion with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 25Dec2020. No therapeutic measures were taken as a result of the events. The events were considered non serious.
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| 42 | 2021-01-04 | nausea, decreased appetite |
arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills ...
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arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills no fever exhausted no appetite arm pain is 60% better today no redness at injection site mild swelling at injection site mentally foggy weak vision
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| 42 | 2021-01-04 | diarrhea |
itching immediately after injection; then burning; then redness traveling up arm into chest; immedia...
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itching immediately after injection; then burning; then redness traveling up arm into chest; immediate onset of diarrhea; This is a spontaneous report from a contactable nurse(patient). A 42-year-old female non-pregnant patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=el0140), intramuscular on 26Dec2020 09:30 at left arm at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient had no known allergies and no other medical history. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced itching immediately after injection, then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. Adverse event start date was 26Dec2020 09:30 AM. The events result in emergency room/department or urgent care. Treatment of Pepcid, Benadryl and prednisone received. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered in Dec2020.
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| 42 | 2021-01-05 | vomiting, nausea | Headache, Myalgia, NauseaVomiting, chills, pain at injection site Narrative: will report to work |
| 42 | 2021-01-05 | nausea |
she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from ...
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she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from the time she got home, all night. and part of day today; this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose; running a fever; Fatigue/she is tired again; very weak; nauseated; Headache; Her throat didn't feel right; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at half dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. It was reported that the patient previously received INFLUENZA VACCINE for immunization but she gets nauseated and tired. On 29Dec2020, she was very weak, nauseated, had a headache, fatigue and her throat didn't feel right. On 30Dec2020, she was running a fever, it was 100.5 (units unspecified). It was also reported that she could barely walk; further reported as couldn't walk hardly, she was still feeling "cruddy" and she just doesn't feel good at all. The patient reportedly slept from the time she got home, all night and part of day today. After she rests for a while, once she gets up, she is tired again. It was also reported that the patient was told that this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose. She will receive her second dose on 19Jan2021. Outcome of the events "very weak" and "fatigue/she is tired again" was recovering; outcome of events "nauseated", "headache", "her throat didn't feel right" and "running a fever" was not recovered; outcome of the events "could barely walk/couldn't walk hardly", "feeling cruddy/doesn't feel good at all" and "slept from the time she got home, all night and part of day today" was unknown. Information about lot/batch number has been requested.
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| 42 | 2021-01-06 | abdominal pain, diarrhea |
Diarrhea left arm pain; abdominal pain 12/22 - vaccinated 12/23 onset of left arm pain and couldn't ...
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Diarrhea left arm pain; abdominal pain 12/22 - vaccinated 12/23 onset of left arm pain and couldn't lift her arm. 12/24 arm pain improved. 12/25 felt normal and healthy 12/26 stomach sharp pain, diarrhea and felt shaky. 12/30 tested negative for COVID-19. 12/31 - symptoms persisted through today and have improved for the first time today. Left with only mild abdominal ache. Not sure the abdominal symptoms are related to the vaccine. She was advised to seek medical care if symptoms persist or worsen.
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| 42 | 2021-01-06 | diarrhea, nausea | Diarrhea, nausea, Temp 102, body achestx with Ibuprofen with some relief |
| 42 | 2021-01-06 | nausea, vomiting |
Extreme weakness, profuse sweating, severe headache, body aches, Temp 102.4, nausea and vomiting, fa...
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Extreme weakness, profuse sweating, severe headache, body aches, Temp 102.4, nausea and vomiting, fatique
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| 42 | 2021-01-06 | vomiting, nausea | Headache, Myalgia, Arthralgia & Nausea Vomiting |
| 42 | 2021-01-06 | diarrhea, nausea |
I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vacci...
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I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vaccination. After the vaccination, I had a fever for 1.5 days, muscle aches, weakness, nausea, diarrhea, headache, fatigue, cough. I had a rash that appeared after I got COVID-19, the rash never went away. After the vaccination, the rash became redder, enlarged, and spread.
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| 42 | 2021-01-06 | diarrhea | chills, cold sweats, diarrhea, muscle aches |
| 42 | 2021-01-07 | nausea |
3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint...
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3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint pain, chills, shot area is swollen, nausea, lymph nodes swollen and sensitive to touch. Face is tender. SOB with movement and dizziness. Patient is a cancer survivor and she said that it feels like she had a chemo treatment.
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| 42 | 2021-01-07 | vomiting |
After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the wait...
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After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the waiting area to be monitored and my tongue and lip started itching. I then started w/ a red rash to the R side of my neck. My body started to itch all over. I was brought into a treatment room and my vital signs were being taken when I started to have an increase in coughing, shortness of breath and vomiting. I was given an epipen and brought to the emergency room when I received Benadryl 50mg IV, Solumedrol 125mg IV, and Pepcid 20mg IV. Approximately 1 hour after receiving the medication my face again began to itch and I was given an additional dose of 25mg of Benadryl. My reaction resolved and I was discharged home with a prescription for prednisone.
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| 42 | 2021-01-07 | nausea |
Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asth...
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Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-01-07 | nausea |
Headache within 45 min of injection. Nausea and Headache after 24 hours. Currently almost 36 hours l...
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Headache within 45 min of injection. Nausea and Headache after 24 hours. Currently almost 36 hours later I am still nauseous. I took Zofran. And extra strength tylenol. My blood sugars are running a little high despite insulin pump and frequent monitoring. No ketones. Temp is 100.
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| 42 | 2021-01-07 | nausea, vomiting | Headache, nausea and vomiting |
| 42 | 2021-01-07 | nausea |
When I woke up on the 21st to go to work I felt vertigo, nauseated and a terrible headache. I pushed...
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When I woke up on the 21st to go to work I felt vertigo, nauseated and a terrible headache. I pushed through and worked the whole shift. I was off due to the holidays for some days but symptoms did not improve. I had the vertigo and nausea for 11 days and on day 7 it prompted me to seek medical care at the clinic. The headache lasted only 2 days.
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| 42 | 2021-01-07 | nausea |
When I woke up on the 21st to go to work at 5AM I felt Vertigo, nausea, and a slight headache the ve...
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When I woke up on the 21st to go to work at 5AM I felt Vertigo, nausea, and a slight headache the vertigo was the debilitation factor. I went to work because it was too late to call in sick, I managed to stay the whole day and then I was off some days due to the holidays. The nausea and vertigo lasted 11 days the headache lasted 2 days. I decided to go to the walk in clinic (day 7 - 12/29) because the vertigo and nausea would not go away. They run bloodwork all normal. They told me to take OTC meclizine. It took the edge off helped a tiny bit. I woke up 01/01 symptom free.
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| 42 | 2021-01-07 | difficulty swallowing |
immediately after to covid vaccine, client started c/o difficulty swallowing. She was transported to...
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immediately after to covid vaccine, client started c/o difficulty swallowing. She was transported to their emergency care area, vitals were monitored. Approx 10mins after this episode, she told them she has had this problem for the last 2 weeks. She denies shortness of Breathe or chest pain. Client was release to a family member. Her husband said she never had any other problems, except the shot made her "tired and achey". She was referred to her PCP for follow up>
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| 42 | 2021-01-08 | nausea |
2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp w...
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2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp with while alternating Tylenol/Advil q4h, large swollen lump in armpit and below clavicle which are extremely painful (on side of body where vaccine was administered). Stiff neck and jaw, severe headache, mild dizziness (was much worse after the 1st dose), nausea, fatigue.
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| 42 | 2021-01-08 | nausea |
The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the ...
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The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the night with pain. The day after: moderate to severe pain on the left arm that radiates to the neck and back. Took Ibuprofen in the morning. Pain was getting better as the day pass. At night, around 6 pm started to feel that something is not OK. I am not the same as before. My legs are not very strong (feeling it, not a problem that I can?t walk - it feels like). Feeling dizzy at times. Went to bed and pain on the left arm is much better. Two days after the vaccine: woke up with body aches, feeling dizzy at times, weak, nauseous. Not feeling OK. It is now around11:30 am two day after the vaccine and I am starting to get worried. Please contact me for advise. Thanks
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| 42 | 2021-01-09 | difficulty swallowing | I HAD SUDDEN MILD THROAT DISCOMFORT DIFICULTY SWOLLOWING THAT NEVER WENT ALWAY. |
| 42 | 2021-01-10 | decreased appetite |
-day after vaccine, experienced headache, temp of 101, body aches/chills, no appetite. -headache las...
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-day after vaccine, experienced headache, temp of 101, body aches/chills, no appetite. -headache lasted for 24hrs after, body aches chills decreased w/tylenol. Still decreased appetite until 3rd day fever was down to 99-100 w/tylenol
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| 42 | 2021-01-10 | nausea | 5 min - nausea 25 min- Nausea, diaphoretic, wheezing 30 min- Vitals WNL, symptoms resolving. |
| 42 | 2021-01-10 | appendicitis, abdominal pain |
Acute appendicitis; Severe acute abdominal pain; Chills; Fever; This is a spontaneous report from a ...
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Acute appendicitis; Severe acute abdominal pain; Chills; Fever; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiration date Mar2021, incomplete lot number L0140, not sure the first letter it is C or E), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. None medical history. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient experienced a little bit chills and fever she felt coming exactly on the 26th but she expected that and that was all fine but patient ended up in (Incomplete sentence). She went to work on 30th December and had some onset of severe acute abdominal pain and she ended up in an emergency appendectomy by 6 O'clock that evening. So she had an acute appendicitis and she did some research and it says that she can be listed in to the severe complications that the number in the vaccinated group was double back to the procedural group. The 26th it resided and patient felt better until the 30th when she have acute severe abdominal pain onset. She left work went for emergency room and she was in surgery within four hours. The outcome of events chills and fever was recovering, the other events was unknown. Because of the research that is on the website patient cannot help and think that it is related. Patient believed the relatedness of drug to events was related. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 42 | 2021-01-10 | difficulty swallowing |
After 15 minute waiting period, patient returned to work in healthcare system, reported flushing and...
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After 15 minute waiting period, patient returned to work in healthcare system, reported flushing and difficulty swallowing. Patient presented to emergency department.
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| 42 | 2021-01-10 | difficulty swallowing |
After receiving vaccine began to feel dizzy and lightheaded and sat in observation area and develop...
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After receiving vaccine began to feel dizzy and lightheaded and sat in observation area and developed a diffused urticarial rash and was sent to ED. She also C/O of difficulty swallowing. Erythema B/L cheeks, Rash diffused B?L chest and behind left ear Patient given Benadryl 25 mg IV at 11:15, Pepcid 20 mg IV given 11:15, SOLU-MEDROL 125 given at 11:30 13:20 feeling much better and has fontal headache discharged home at 14:20
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| 42 | 2021-01-10 | diarrhea | Arm swelling, Red spot at site of vaccine. Diarrhea, Pain Scalp pain. |
| 42 | 2021-01-10 | difficulty swallowing |
Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 mi...
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Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 minutes without intervention. Remained in the observation room symptom-free for additional 30 minutes. At home, symptoms of shortness of breath and chest tightness returned and worsened. Throat felt tight, able to move air, however had trouble swallowing. Voice was raspy and increased coughing. From past experience with allergy shots, this was my cue to use epi pen. Within 5 minutes after using epi pen, all symptoms were resolved.
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| 42 | 2021-01-11 | diarrhea, vomiting | Dizziness for 4 days vomiting body aches and severe diarrhea |
| 42 | 2021-01-11 | nausea | Flu like symptoms, syncope, lymphadenopathy, nausea, fatigue, weakness. |
| 42 | 2021-01-11 | nausea, vomiting | Headache, nausea, vomiting, dizziness, body aches, pain at injection site, chills,fatigue |
| 42 | 2021-01-11 | nausea | Nausea, dizziness, fatigue, constipation, lower back pain. |
| 42 | 2021-01-11 | nausea |
The day after the vaccine was given, 01/07/2021, I had a headache and nausea around 10:00am. I had ...
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The day after the vaccine was given, 01/07/2021, I had a headache and nausea around 10:00am. I had to leave work early. I fainted when I got home on Thursday. Felt very tired. So I rested the remainder of the day and that night. On Friday 01/08/2021, I felt very tired and had a temperature of 100.6. I slept most of the day. Friday night I fainted again around 8:00pm. Slept all night. Felt much better on Saturday. Felt normal from Sunday on.
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| 42 | 2021-01-11 | nausea |
Vaccine given at 9;55 am and at 10;10 am patient c/o dizziness, nausea, fast heart rate. VS taken ...
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Vaccine given at 9;55 am and at 10;10 am patient c/o dizziness, nausea, fast heart rate. VS taken BP 116/78 HR 105, O2 sats 100. Pt was given water, raised her feet up and monitor her for additional 30 mins. 10:30am pt. states felt much better new VS taken BP 110/70 sats 100% HR 94, she left via walking.
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| 42 | 2021-01-11 | vomiting |
Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush fa...
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Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush face
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| 42 | 2021-01-11 | nausea |
Woke up on 1/9 with major headache. During the day this progressed to nausea, body aches, chills an...
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Woke up on 1/9 with major headache. During the day this progressed to nausea, body aches, chills and fever 100.4.
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| 42 | 2021-01-11 | nausea, vomiting | headache, nausea, vomiting. called in sick to work. |
| 42 | 2021-01-12 | difficulty swallowing |
2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep chok...
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2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.
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| 42 | 2021-01-12 | diarrhea, nausea |
About 20 min after my chest started feeling tight. 3 hours later my stomach started feeling queasy.....
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About 20 min after my chest started feeling tight. 3 hours later my stomach started feeling queasy...later that night I started with loose stools...The queasiness and loose stools lasted through the next day and than were gone. My muscles in my back, jaw, and arms seem to get tight and than release...almost like spasms....it feels like my jaw is trying to lock. ...This started the first night and is still continuing now.
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| 42 | 2021-01-12 | nausea |
Chills; Low grade fever; Nausea; Pain; Swollen lymph nodes in armpit; This is a spontaneous report f...
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Chills; Low grade fever; Nausea; Pain; Swollen lymph nodes in armpit; This is a spontaneous report from a contactable Healthcare Professional (patient).This 42- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EL3246), via an Intramuscular route of administration, on 06Jan2021 09:15AM (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient did not have any allergies to medications, food, or other products. Medical history included: Mitral valve prolapse. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EH9899) via an Intramuscular route of administration, on 18Dec2020 at 03:30 PM (at the age of 42-years-old) as a single dose for COVID-19 vaccination, anatomically located on the right arm. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jan2021 at 01:30 AM, she experienced chills, low grade fever, nausea, pain, and swollen lymph nodes in armpit. The patient did not receive treatment for the events. The clinical outcome of the events chills, low grade fever, nausea, pain, and swollen lymph nodes in armpit was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-01-12 | nausea | Nausea, dizziness, chills, headache |
| 42 | 2021-01-12 | nausea |
Patient reports nausea, very extreme and sudden, chills, mild fever (100.5 degrees) and extreme fati...
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Patient reports nausea, very extreme and sudden, chills, mild fever (100.5 degrees) and extreme fatigue.
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| 42 | 2021-01-12 | nausea |
Sore arm nausea fatigue 24-48 hrs. after vaccine administration. Today 1/13/2021- tested covid posi...
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Sore arm nausea fatigue 24-48 hrs. after vaccine administration. Today 1/13/2021- tested covid positive via PCR swab.
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| 42 | 2021-01-12 | difficulty swallowing |
Was unable to swallow, breathing was not affected. Throat muscles felt weaken. Was given a Benadr...
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Was unable to swallow, breathing was not affected. Throat muscles felt weaken. Was given a Benadryl, symptoms resolved soon after.
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| 42 | 2021-01-12 | nausea | chills, fever,body aches,headace,nausea |
| 42 | 2021-01-12 | nausea |
sudden onset nausea, mild fever (100.5), exhaustion. required 15 hours sleep, chills began 1 hour la...
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sudden onset nausea, mild fever (100.5), exhaustion. required 15 hours sleep, chills began 1 hour later. all considered mild but wanted to report for tracking.
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| 42 | 2021-01-13 | nausea |
1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with e...
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1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with ears flushed 1715 nausea, no vomiting, light headedness, mouth dry, tolerated apple jice and crackers 1830 felt normal
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| 42 | 2021-01-13 | vomiting, nausea |
Exactly 15 hrs post injection I woke with uncontrollable shakes, fever 101.6, vomit x4, nausea, Bone...
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Exactly 15 hrs post injection I woke with uncontrollable shakes, fever 101.6, vomit x4, nausea, Bone pain especially neck, lower back and hips, headache and congestion.
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| 42 | 2021-01-13 | difficulty swallowing |
Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a st...
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Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.
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| 42 | 2021-01-13 | decreased appetite, nausea |
Injection site pain that lasted about three days, day one was the worst. Fever of 100.5F, muscle pai...
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Injection site pain that lasted about three days, day one was the worst. Fever of 100.5F, muscle pain, chills, and joint pain on the third day and lasted around six hours. Loss of appetite and nausea lasted about a week. Tiredness and headache lasted almost two weeks.
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| 42 | 2021-01-13 | vomiting, nausea |
Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when g...
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Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when going to bed. Overnight, I started to experience chills followed by extreme perspiration and weakness to the point that I struggled to open a bottle of water I had by my bed. Tuesday, 1/12/2021: Headache, weak and tired but attempted to work. I had to leave shortly after arriving because my symptoms were becoming progressively worse to the point I almost passed out from standing. Upon arriving home, I started to experience nausea and vomiting x 3. Intense chills followed by the extreme perspiration still existed. Most of these symptoms subsided by 9:30p that evening. Wednesday, 1/13/2021: Intense headache, weakness and dizziness. Of note, my left underarm/armpit (the arm where the vaccine was administered) is sensitive to touch.
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| 42 | 2021-01-13 | difficulty swallowing |
Patient developed tight feeling in throat, difficulty swallowing, diaphoretic, clammy skin and facia...
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Patient developed tight feeling in throat, difficulty swallowing, diaphoretic, clammy skin and facial swelling around eyes.
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| 42 | 2021-01-13 | nausea |
acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling ...
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acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling of first 3 fingers in left hand (median nerve distribution); tingling of first 3 fingers in left hand (median nerve distribution).; significant cervical lymphadenopathy; painful neck; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old adult female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: EJ1686, via an unspecified route of administration, in left arm, on 06Jan2021 at 9:52 am, at 42-years of age, at single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included overweight and no known allergies. Concomitant medications included the second dose of HPV VLP vaccine rL1 4v (yeast) (GARDASIL) received in left arm on 18Dec2020 and ergocalciferol (Vitamin D). On 06Jan2021 by 10:05 the patient experienced acute onset nausea, diaphoresis, presyncope and concomitant left arm weakness/flaccid arm with numbness and tingling of first 3 fingers in left hand (median nerve distribution). The patient informed vaccine staff of symptoms and advised ongoing observation. Flaccid arm/weakness/numbness continued for more than 24 hours, although at the time of the report it was slowly improving. At the time of the report the patient further reported significant cervical lymphadenopathy and painful neck (specific onset date not provided - captured as Jan2021). The events were reported as non-serious. The reporter specified that the injection was not given anywhere near brachial plexus. At the time of the report the events "Left arm weakness" and "Left arm numbness" were resolving, the outcome of the events "Nausea", "Diaphoresis", "Presyncope", "Tingling of first 3 fingers in left hand", "Cervical lymphadenopathy" and "Painful neck" was unknown.
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| 42 | 2021-01-13 | nausea |
headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this o...
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headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-14 | nausea, diarrhea |
-Temperature of 101-102.3 for 36 hours, did not reduce with anti-pyretic medication (Tylenol/Ibuprof...
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-Temperature of 101-102.3 for 36 hours, did not reduce with anti-pyretic medication (Tylenol/Ibuprofen). -Chills with shaking -Nausea/diarrhea -Body aches and joint pain -Fatigue
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| 42 | 2021-01-14 | abdominal pain, nausea, diarrhea, vomiting |
5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Conti...
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5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Continued with paresthesias in lips, mouth, tongue, finger, legs, and toes. 2-3 hours after administration developed lip, face and tongue swelling. Administered Zyrtec and tylenol. Symptoms improved but continued into next day. 18 hours after administering vaccine developed rigors, fever (Tmax 103), severe myalgias, fatigue, nausea, vomiting, diarrhea, abdominal cramping. These symptoms persisted for another 12 hours. Tylenol was given to assist fever and pain.
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| 42 | 2021-01-14 | vomiting, nausea, abdominal pain, diarrhea |
After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Conti...
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After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Continued with paresthesias in lips, tongue, mouth, fingers, legs, and toes. 2-3 hours after administration, developed lip swelling, facial swelling, and swelling of tongue. Zyrtec and tylenol were given. This improved but was still present the next day. At 18 hours following administration, developed rigors, fevers (Tmax 103), severe myalgias, nausea, vomiting, diarrhea, and abdominal pain. These persisted for another 18 hours.
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| 42 | 2021-01-14 | nausea, vomiting |
Chills; body aches; nausea; vomiting; fever between 100 and 102 with Tylenol and Motrin that lasted ...
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Chills; body aches; nausea; vomiting; fever between 100 and 102 with Tylenol and Motrin that lasted 36 hrs; This is spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on the left arm first dose on 16Dec2020 06:00 (lot number: EK57303121) and second dose on 07Jan2021 16:45 (lot number: EL3246) at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. On 08Jan2021 05:00 AM, the patient experienced chills, body aches, nausea, vomiting, fever between 100 and 102 with Tylenol and Motrin that lasted 36 hrs. No treatment was received for the events chills, body aches, nausea, vomiting. The events resulted to a doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies to medications, food, or other products. Outcome of the events was recovering.
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| 42 | 2021-01-14 | nausea |
Nausea and headache the evening of the vaccine. Chills, headache, aches and pains, nausea late that...
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Nausea and headache the evening of the vaccine. Chills, headache, aches and pains, nausea late that night into the early morning. Day 6 after receiving vaccine, lymph nodes swollen. Worsened on day 7 and 8. Day 8 after vaccine noticed hives on back. Still have headache and nausea off and on.
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| 42 | 2021-01-14 | nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA Started to feel ill around 8pm 1/11. Woke up with nausea and h...
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Pfizer-BioNTech COVID-19 Vaccine EUA Started to feel ill around 8pm 1/11. Woke up with nausea and headache around 10am 1/12. Cough and fever developed by 4pm 1/12, cough was mild and fever never exceeded 101 degrees Fahrenheit. Also experienced fatigue and body aches. Nausea successfully treated with promethazine. All symptoms dissipated significantly or gone altogether around 1am 1/13.
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| 42 | 2021-01-14 | nausea |
Symptoms started next day with tiredness, low grade temp of 99 and over all not feeling well. Contin...
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Symptoms started next day with tiredness, low grade temp of 99 and over all not feeling well. Continued into Saturday. Sunday, Monday and most of Tuesday felt normal. Tuesday evening started to fell worse and Wednesday 1.13.21, 6 days after shot, headache, nauseous, very tired, could not go to work. Called Doctors office and spoke to two different nurses who advised these were normal reactions although maybe delayed. By end of day headache and nausea were gone but still felt unwell. 1.14.21 well enough to work, mostly normal. Took blood pressure and it was elevated by 20 points! BP is still elevated on 1.15.21.
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| 42 | 2021-01-15 | nausea | Dizziness, nausea |
| 42 | 2021-01-15 | nausea |
Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, sh...
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Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, shortness or breath, muscle stiffness all over and muscle weakness, nausea
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| 42 | 2021-01-15 | nausea |
Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fl...
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Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fluttering? muscle spasms in deltoid 1330 numbness, tingling, muscle spasms in deltoid; 6/10 burning pain in upper arm/armpit, woozy/lightheaded 1345 driving home same as above, nausea, noticed more nasal congestion, post nasal drip 1400 increased nausea, increased symptoms in shoulder/armpit, 4/10 painful deltoid...soreness, burning pain; had a snack 1430 increased severity of symptoms 5-6/10 pain, weird numb feeling in shoulder, itchiness increased; took Tylenol 1530 increased nausea and now chills, cold, shooting cold pain left neck, neck/shoulder stiffness, intermittent ?fluttering? of heart but only for a few seconds (<15sec) 1615 5/10 worsening pain in L dorsal lower arm 1730 increased nausea, chills, cold shooting pain still present intermittently, numbness extends to medial & lateral upper arm 4-5inches from biceps tendon insertion 1830 feeling a little better after eating 2100 overwhelmingly tired, significantly less numbness and tingling, 6/10 pain/soreness in Left deltoid, stretched, took Tylenol, noticeable increase in nasal congestion, post nasal drip, no trouble breathing or cough, temp 97.5F 2200 increased L shoulder pain/muscle tightness, numbness gone, replaced by armpit 4/10 tenderness upon light palpation, alternating between chills and clamminess, feel really ?hot? despite oral temp 97.5F 01/16/2021 0100 6/10 shoulder pain/tenderness/stiffness, armpit significantly less tender 1/10, significantly less numbness or cold, shooting pain; feel really hot, almost sweating despite room temp 68F and oral temp 97.3F ?totally awake? 0130 got up, void x1, made chamomile tea, took 10mg melatonin, 500mg Tylenol, a ?little nauseated? 0800 woke up, 6/10 constant pain in left deltoid, no numbness, tingling or cold sensations 0830 Took Tylenol with breakfast and rest of vitamins 1200 increased pain (6/10) in L deltoid, mild nausea; increased lightheadedness, fatigue, and ?achy? feeling throughout body. 1230 Took Tylenol 1300 pain 5/10, mild nausea, and lightheadedness, but increased fatigue and ?achy? feeling throughout body 1700 mild/moderate constant pain in L deltoid, mild nausea, fatigue, achy feeling 1800 tookTylenol with dinner 2000 increased fatigue, mild achy feeling and chills, no nausea 2200 increased nausea, 5/10 constant pain in L deltoid Took Tylenol 500mg and went to sleep.
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| 42 | 2021-01-16 | difficulty swallowing |
Less than 2 min after administration developed throat fullness and difficulty swallowing. This pers...
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Less than 2 min after administration developed throat fullness and difficulty swallowing. This persisted. Never any wheeze, never any SOB
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| 42 | 2021-01-16 | nausea |
On 1/15/21, the day of the shot I had slight nausea, a sore arm around the injection site and fatigu...
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On 1/15/21, the day of the shot I had slight nausea, a sore arm around the injection site and fatigue in the evening. On 1/16/21, day two I had nausea after eating breakfast, extreme fatigue, muscle aches and joint pain. I also had a sore throat and odd sour taste in the morning, both days following the shot. This morning, day 3 I feel tired with less aches.
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| 42 | 2021-01-16 | nausea |
Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the mor...
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Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the morning of 1/14/21. Pain got steadily worse to the point of full body myalgias, severe fatigue/weakness and severe nausea. Almost passed out at work and ended up being bedridden for the rest of the day on 1/14 and all day 1/15 and 1/16. Also had hematuria that developed on 1/15. Went to urgent care clinic on 1/16 and received one bag of IV fluids and zofran for the nausea. CBC, CK, CMP all normal but 1+ hematuria on U/A. Symptoms finally improved on 1/17
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| 42 | 2021-01-17 | difficulty swallowing, nausea |
10:35a: COVID vaccine #1 Sitting in monitoring room. 11:05a: checked for symptoms and reports shor...
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10:35a: COVID vaccine #1 Sitting in monitoring room. 11:05a: checked for symptoms and reports shortness of breath and wheezing. Has history of asthma and has albuterol with her. 11:08a: O2 100% RA, HR 116 Took albuterol inhaler x2 puffs Ongoing shortness of breath. Reports sharp pain in her chest. Reports dizziness. 11:10am BP: 110/84, O2 99%, HR 113. No wheezes on exam Drank fluids and given snack. Reports difficulty swallowing. Sharp pain in chest is worsening. Shortness of breath worsening. Reports nausea. 11:18a: glucose 178. HR 112, O2 100%. Ongoing sharp pain in chest and worsening shortness of breath 11:20a: Given Benadryl 25mg and orange juice. 11:30a: Requests to go to ER ? 911 was called. Repeats albuterol inhaler 11:40a Reports shortness of breath worsening and closing sensation in her throat. Burning sensation in her mouth. Chest pains worsening and ongoing dizziness. Given epipen 0.3mg [due to shortness of breath, sensation of throat closing, nausea, dizziness, tachycardia] 11:43a: EMS arrive, assess and transport to ER
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| 42 | 2021-01-17 | nausea |
AFTER INJECTION PATIENT FELT WARM SENSATION IN HER TORSO. PATIENT ALSO STATED SHE HAD A HEADACHE, NA...
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AFTER INJECTION PATIENT FELT WARM SENSATION IN HER TORSO. PATIENT ALSO STATED SHE HAD A HEADACHE, NAUSEA AND BOIDY PAIN. PATIENT WAS PALE WHEN PLACED IN AMBULANCE AND GIVEN OXYGEN AND HAD HER FEET ELEVATED. PATIENT WAS IN AMBULANCE FOR ABOUT 25 MINUTES AND COLOR DID NOT COME BACK TO NORMAL EVEN AFTER THE OXYGEN ADMINISTRATION. THE PATIENT WAS ADVISED AND CONVINCED TO ALLOW THE AMBULANCE TO TRANSPORT HER TO HOSPITAL TO BE ASSESSED WHICH SHE AGREED TO. I CALLED THE PERSON ON 1/17/2021 @ 8:54 PM AND SHE STATED THAT SHE STILL FEELS A LITTLKE UNDER THE WEATHER BUT IT HAS GOTTEN BETTER
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| 42 | 2021-01-18 | nausea |
Feel bad; Bad headache; Nausea; Dizzy happens when I move around and change position; Dizzy happens ...
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Feel bad; Bad headache; Nausea; Dizzy happens when I move around and change position; Dizzy happens when I move around and change position; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date was not reported) on the left arm on 06Jan2021 (15:00) at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication included ibuprofen. On 07Jan2021 (12:30 AM), the patient had felt bad; bad headache; nausea; and was dizzy which happened when she moved around and changed position. The patient had received paracetamol (TYLENOL) and diphenhydramine (BENADRYL) as treatment for the reported adverse events. The outcome of the events, 'felt bad', 'bad headache', 'nausea' and 'dizzy which happened when she moved around and changed position', was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested since the vaccination. The patient had COVID-19 test which was negative on 08Jan2021.
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| 42 | 2021-01-18 | abdominal discomfort |
Sunday evening developed lower pelvic pressure which continued to Tuesday. Called my OB MFM office a...
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Sunday evening developed lower pelvic pressure which continued to Tuesday. Called my OB MFM office and was instructed to come in for a check up. I am currently 18wks 4 days (was exactly 18 weeks on date I received dose 2). At the OB MFM clinic I was discovered to have a shortened cervix of 2cm. I did not have this occur in my prior term pregnancy. Although there may be no causal link I felt it important to report as there may be an association with the vaccine and cervical length/risk of preterm delivery.
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| 42 | 2021-01-19 | difficulty swallowing |
5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins:...
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5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins: difficulty swallowing, tight breathing Pt was given 2nd round of 25 mg benedryl, epinephrine, Prednisone, albuterol breathing treatment and monitored for 3 hours. Sent home on 5 day course or prednisone
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| 42 | 2021-01-19 | decreased appetite |
Intense chills onset about 12h after vaccine and lasted for 3-4 hours, with a max temp of 101.2 tha...
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Intense chills onset about 12h after vaccine and lasted for 3-4 hours, with a max temp of 101.2 that lasted around another 20 hours. Muscle aches, weakness, fatigue and decreased appetite for duration of fever. Took excedrin for severe headache once fever broke. Symptoms completely resolved 12h later, after sleeping.
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| 42 | 2021-01-19 | nausea, vomiting |
Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until...
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Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until it passed. Day 6, another migraine. Ibuprofen and caffeine. Day 7 I went to get a haircut thinking the migraines may be caused by heavy long hair. Day 8 extremely painful migraine, can?t open eyes as light made it worse, nausea, vomiting. Called my PCP, they recommended going to urgent care after I vomited. I couldn?t get a ride so I took ibuprofen, Tylenol, and hydroxyzine to help me sleep until it?s gone.
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| 42 | 2021-01-19 | nausea |
arm pain for 5 days, nausea for a day or two then came back, on going dizziness and headache. Treat...
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arm pain for 5 days, nausea for a day or two then came back, on going dizziness and headache. Treated with ibuprofen, Tylenol, Zofran which has helped some, but all comes back and now for 2 weeks.
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| 42 | 2021-01-19 | nausea, abdominal pain |
within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all ov...
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within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all over & I asked for Benadryl. I was taken to the ED dept. I was given zofran 4mg and Meclizine for vertigo and IV after 4 hrs. I Was told to go home and sleep it off. I've home with joint pain, muscle aches, nausea, abdominal pain, foggy mind, tiredness, weakness. Saw my PCP today. Rest, zofran and meclizine PRN hydration and rest.
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| 42 | 2021-01-20 | nausea |
14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120....
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14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120. I went home from work and became itchy to my neck and arms . At about 20 hours later I became short of breathe and pulse standing would go up to 140. I rested and continued taking Motrin and Tylenol as suggested . I ate minimally despite nausea . I messaged my Dr the next AM. By that time my glucose was settling down to normal and my Bp and pulse . The headache got worse and I had a pain in my axilla on the same arm I received the vaccine. I developed ?lymphadema? in that area which is sore to touch or move my arm. I reached out to infectious disease Dr at the hospital I work at and he suggested to continue Tylenol and Motrin and wait a week as this is due to vaccine. It is now Day 3 following vaccine and I am yet unable to work. My arm and axilla area is sore and I can?t lift my arm without pain, I have headaches and nausea as well.
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| 42 | 2021-01-20 | nausea | Fever, chills, body aches, nausea |
| 42 | 2021-01-20 | nausea |
Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and mu...
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Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and muscles; Tiredness/felt tired; fast heartbeat; Difficulty breathing; Dizzy; Nausea; Joint pain; Muscle pain; she was not feeling well; swelling and tightness in her left arm; swelling and tightness in her left arm; Injection site redness/redness of her left arm and injection site swelling; Injection site swelling; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in upper left arm, on 08Jan2021 09:25, at single dose, for COVID-19 immunization, in a public health department. There were no medical history and concomitant medications. The patient did not receive prior vaccinations within 4 weeks. The patient reported she received the COVID-19 Vaccine on Friday, clarified as 08Jan2021 at 9:25 in her left upper arm. She stated experiencing a little bit of side effects since receiving the COVID-19 Vaccine. Shortly after receiving the COVID-19 Vaccine, on 08Jan2021, she was not feeling well. She said she had swelling and tightness in her left arm that started approximately a half hour (30 mins) after receiving the COVID-19 Vaccine on 08Jan2021. She then experienced redness of her left arm and injection site swelling on 08Jan2021. On 10Jan2021 (at night), she felt tired, and had tightness of her joints and muscles. She also experienced a fast heartbeat, and difficulty breathing last night, 10Jan2021. She said her dizzy feeling, nausea, tiredness, and joint and muscle pain were persisting at the time of the report. She reported she thought she was feeling fine up until Sunday, 10Jan2021. She stated her new symptoms started in the late afternoon, and the symptoms have stayed into the morning of 11Jan2021. She reported having previously scheduled a doctor's appointment for 22Jan2021 and will speak with her doctor at that time if she continues to have symptoms. The patient declined treatment for the events. The outcome of the events are joint stiffness, muscle tightness, fatigue, dizziness, nausea, arthralgia and myalgia was not recovered; peripheral swelling, musculoskeletal stiffness, heart rate increased and dyspnea were recovering; vaccination site erythema and vaccination site swelling were recovered on an unspecified date; and malaise was unknown.
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| 42 | 2021-01-20 | nausea |
Tiredness; muscle and joint pain; muscle and joint pain; injection site pain; nausea; multiple swoll...
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Tiredness; muscle and joint pain; muscle and joint pain; injection site pain; nausea; multiple swollen lymph nodes in the side of neck that are painful and the size of llama beans, nickels and dimes; multiple swollen lymph nodes in the side of neck that are painful and the size of llama beans, nickels and dimes; I fell like I have a bad flu; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: Ek5730, intramuscularly in left arm on 18Dec2020 10:30 AM at single dose for COVID-19 immunisation. Facility type vaccine was hospital. Medical history was none, no known allergies. The patient didn't have COVID prior vaccination. Concomitant medication in 2 weeks included ibuprofen, phentermine, paracetamol (TYLENOL), valacyclovir. The patient didn't have other vaccine in four weeks. The patient experienced tiredness, muscle and joint pain, injection site pain, nausea, multiple swollen lymph nodes in the side of neck that were painful and the size of llama beans, nickels and dimes. She felt like she had a bad flu. Adverse events start date was 02Jan2021 08:30 AM. It was unknown if treatment was received for the events. COVID was not tested post vaccination. Outcome of the events was recovering. The patient received the second dose of BNT162B2, lot number: Ek9231, intramuscularly in left arm on 08Jan2021, 06:15 PM.
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| 42 | 2021-01-20 | nausea |
pain on the joints, and legs (the feeling that inside the legs are stiff).; pain on the joints, and ...
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pain on the joints, and legs (the feeling that inside the legs are stiff).; pain on the joints, and legs (the feeling that inside the legs are stiff).; woke and I was nauseus.; Pain is radiating to back and neck/I can't bend over that I feel pain from the neck to the head on the left side only.; I started to feel a little weaker, body aches.; I started to feel a little weaker, body aches.; unable to lift arm completely; Pain is radiating to back and neck; sore left arm after couple hours; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 07Jan2021 11:45 at left arm, at single dose for covid-19 immunization. Medical history was none. Known allergies was NKA/NKDA. Concomitant medication included methylcellulose (CITRUCEL), ergocalciferol (VIT D), vitamin b complex (B-COMPLEX), ubidecarenone (COQ 10) and birth control. The patient was not pregnant at the time of vaccination. The patient experienced sore left arm after couple hours on 07Jan2021 18:00. At night took Ibuprofen to help with pain. Pain woke the patient up at night. On 08Jan2021, left arm was very sore, unable to lift arm completely. Pain was radiating to back and neck. Took Ibuprofen. At night she wasn't feeling the same. She started to feel a little weaker, body aches. Her legs felt strange, as if there was some pressure, that veins were stiff. On 09Jan2021, the patient woke and was nauseas. Arm was not very sore but neck was. She couldn't bend over that she felt pain from the neck to the head on the left side only. At night her legs started to feel the pressure again. It seemed like pain on the joints. She didn't feel the same. On 10Jan2021, woke up with pain on the joints, and legs (the feeling that inside the legs were stiff). She was afraid that she was having an unusual, serious reaction and not aware of it. The outcome of the event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
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| 42 | 2021-01-21 | abdominal pain, nausea, diarrhea |
12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client ...
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12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client improved that evening. 1/20/2021 Four hours after second vaccine dose - Body aches, intense headache over right eye, The evening of the same day - Heaviness to left arm, increased pain to left arm radiating to hands, tightness to the left arm with a feeling of "electricity" in the arm. The pain increased in intensity to the left arm during the night. Unable to sleep due to intense pain to the left arm and axilla. 1/21/2021 In the morning, client experienced abdominal pain and diarrhea once (loose stool). She noted swelling to the left axilla, intense pain, swelling below the left jawline. 1/22/2021 Early morning nausea without emesis, itching of the right forearm and nape of the neck, throbbing pain to left axilla with itching, throbbing to the left ear, which has not been sensitive to pain due to deafness.
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| 42 | 2021-01-21 | nausea, vomiting | Body aches, chills, headache, dizziness, ringing in the ears, nausea, vomiting, and fatigue |
| 42 | 2021-01-21 | nausea |
Chills, major body aches, nausea, massive headache, tiredness from 4am to 3:30 pm 1/21/21. Around 11...
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Chills, major body aches, nausea, massive headache, tiredness from 4am to 3:30 pm 1/21/21. Around 11 am, I was get to find some stregth to get out of bed and take some Ibuprofen.After that time minor fatigue, minor muscle ache and headache. In the morning of 1/22/21 about 7am feeling 50% better. About noon about 90% better.
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| 42 | 2021-01-21 | nausea |
Headache with strobe light in periphery-left eye. Later, chills, body aches, slight nausea, fever of...
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Headache with strobe light in periphery-left eye. Later, chills, body aches, slight nausea, fever of 101.2 at highest temp recorded. Started on 1/20 at around 9 pm. Symptoms subsided early morning of 1/22.
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| 42 | 2021-01-21 | nausea | Headache, muscle ache, joint pain, low grade fever, nausea, fatigue. Symptoms lasted only few hours. |
| 42 | 2021-01-21 | nausea |
Noticed a few hours after I got vaccine. Not exactly sure exact time because work nights and came ho...
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Noticed a few hours after I got vaccine. Not exactly sure exact time because work nights and came home and went to sleep after vaccine . Achy spine, front of my head hurt, nauseous. Same 2nd day. 3rd day just achy spine. Slept on and of last few days. Did not call Dr. Or go into office because symptoms didnt worsen. I work in hospital and kept in contact with EHO on monitoring steps i needed to take.
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| 42 | 2021-01-21 | nausea |
Severe nausea, chills, joint pain, muscle aches, headache, itching. Still have the rash from prior v...
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Severe nausea, chills, joint pain, muscle aches, headache, itching. Still have the rash from prior vaccination so have MD visit later today for the nausea and rash/itching.
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| 42 | 2021-01-21 | nausea | nausea, rash, joint pain, muscle aches |
| 42 | 2021-01-21 | abdominal pain upper, abdominal distension | stomach cramps and bloating |
| 42 | 2021-01-22 | nausea |
Almost exactly 12 hrs after 2nd vaccine, had chills, moderate headache, nausea. Able to sleep but in...
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Almost exactly 12 hrs after 2nd vaccine, had chills, moderate headache, nausea. Able to sleep but in the AM had severe headache, nausea, malaise, muscle aches, soreness at injection site
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| 42 | 2021-01-22 | vomiting, decreased appetite, abdominal pain |
Day 1. Fatigue. Sleepiness. Loss of appetite Day 2. Muscle aches. Headache. Chills. Loss of appetit...
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Day 1. Fatigue. Sleepiness. Loss of appetite Day 2. Muscle aches. Headache. Chills. Loss of appetite. Episode of severe abdominal pain, chest pain, right shoulder pain, shortness of breath, syncope, diaphoresis, vomiting Day 3. Fatigue. Headache. Chest pain.
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| 42 | 2021-01-22 | nausea, diarrhea | Headache, chills, nausea, diarrhea, extreme fatigue, body aches, mild confusion |
| 42 | 2021-01-22 | nausea | Nausea greater than 4 hours. Lightheaded |
| 42 | 2021-01-22 | nausea |
While sitting in observation patient became dizzy, felt nauseated and became pale. EMS was called t...
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While sitting in observation patient became dizzy, felt nauseated and became pale. EMS was called to her side. Her BP was elevated and she remained pale & dizzy. She was taken to ED. No medications were administered.
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| 42 | 2021-01-22 | nausea | dizziness, nausea, slight shortness of breath/anxiety |
| 42 | 2021-01-23 | abdominal pain upper |
Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, ...
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Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, severe muscle and joint pain, hypertension, tachycardia, severe skin sensitivity, abdominal epigastric pain and spasms, severe cough, dizziness, lightheadedness. Reaction symptoms were not all immediate and developed over next 3 days requiring evaluation and treatment in the ER. I required decadron injection to stop inflammatory response and was sent home on oral decadron. I am still experiencing symptoms but not as severe. I have to take my albuterol inhaler so I can breathe easier. My monocytes count was elevated.
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| 42 | 2021-01-24 | nausea, vomiting |
12 hours after receiving the first dose I started having chills. Shortly after that I begin to exper...
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12 hours after receiving the first dose I started having chills. Shortly after that I begin to experience nausea vomiting bodyaches dizziness headache and arm soreness. This lasted for approximately 24 hours. After that symptoms went away except for arm soreness which lasted for a few more days.
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| 42 | 2021-01-24 | nausea |
12/23/20 1st dose: very sore arm at injection site 1/14/21 2nd dose (lot: EJ1686): sore arm at injec...
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12/23/20 1st dose: very sore arm at injection site 1/14/21 2nd dose (lot: EJ1686): sore arm at injection site, extreme fatigue, high fever (103), shaking, muscle/body aches, nausea
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| 42 | 2021-01-24 | nausea |
About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, ...
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About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.
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| 42 | 2021-01-24 | decreased appetite, nausea |
Approximately 12 hours after receiving the second dose of Covid I begin having chills. Shortly after...
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Approximately 12 hours after receiving the second dose of Covid I begin having chills. Shortly after that I also experienced nausea bodyaches headache lack of appetite dizziness as well as a sore arm with redness at the injection site. My arm is red, warm to touch, firm and has gotten slightly larger since day 2. It is now day 4 and I still have this red welt on my arm that is tender to touch. The other symptoms resolved after 24 hours.
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| 42 | 2021-01-24 | diarrhea | CHILLS, DIARRHEA, FATIGUE, HEADACHE |
| 42 | 2021-01-24 | diarrhea | CHILLS, DIARRHEA, FATIGUE,HEADACHE |
| 42 | 2021-01-24 | diarrhea | Chills, diarrhea, fatigue, headache, |
| 42 | 2021-01-24 | diarrhea | Felt miserable, collapsed, blacked out for unknown length of time, diarrhea, sweating, hot flashes. |
| 42 | 2021-01-24 | diarrhea |
Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; m...
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Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19.
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| 42 | 2021-01-24 | diarrhea, nausea | Severe headache (worse than a normal migraine) Nausea Diarrhea |
| 42 | 2021-01-24 | abdominal discomfort | Sore throat, then headache and nasal congestion with variable gastrointestinal upset |
| 42 | 2021-01-24 | nausea, abdominal discomfort, abdominal pain upper |
Timeline reported by patient as follows. Monday: 1-4-2021 Cold feeling down my arm, within 30 mins ...
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Timeline reported by patient as follows. Monday: 1-4-2021 Cold feeling down my arm, within 30 mins felt nauseous- got something to eat since didn't eat before- felt better throughout the day until around 3 pm. That is when my arm was very sore and pain down my right leg. This pain increased throughout the evening and other joints were affected including hips shoulders sternum, knees and ankles- overall body aches. Difficulty sleeping due to pain. Low grade fever of 99.9. Tuesday: 1-5-2021 Very sore arm but went away by midafternoon. about 5:30pm started having stabbing stomach pains that came and went throughout the night. Heat applied to help a little bit. Low grade fever 99.6 Wednesday: 1-6-2021 Woke up with some stomach pain but not stabbing. Still had body aches and still not able to sleep through the night (this is uncommon for me- i sleep hard through the night)- Keft work early due to not feeling well. Temp 99.9 Thursday: 1-7-2021 Tired, body aches, still some stomach issues, not able to sleep through the night Friday:1-9-2021 Tired, stomach feels unsettled, body aches, up again throughout the night Saturday: 1/10/2021 Tired, no energy, stomach feel nauseous at times, body aches still present- tried to get some sleep during the day as well Sunday: 1-11-12021 Tired, still not restful sleep, bodys aches, chills, temp 99.9 Monday: 1-12-2021 Woke up in pain throughout body, some nausea, fever comes and go with high of 99.9 and low of 97.8. Chills with the higher temp., Emotional unable to stop crying for no reason (maybe because I'm not getting sleep?) Took 1/2 day of PTO due to not feeling well. headache Tuesday: 1-13-2021 Took PTO all day Pain throughout the body, nausea, exhausted, still not able to sleep all the way through the night- up multiple times for multiple hours, trying to get sleep thoughtout the day but still not getting a lot. Wedensday: 1-14-2021 Took PTO, continued body aches, stomach issues, no fever Thursday: 1-14-2021 Body aches, stomach pain and issues, no fever as of yet, headache,
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| 42 | 2021-01-25 | nausea |
2 days after vaccine woke up with a fever of 102, severe headache, chills, eye pain upon movement, n...
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2 days after vaccine woke up with a fever of 102, severe headache, chills, eye pain upon movement, nausea--took until 1/22 to resolve
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| 42 | 2021-01-25 | nausea |
Chills, nausea, fever, sweats x 24 - 48 hours; headache, fatigue, painful swollen lymph nodes (left ...
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Chills, nausea, fever, sweats x 24 - 48 hours; headache, fatigue, painful swollen lymph nodes (left posterior cervical) x 72 hours
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| 42 | 2021-01-25 | diarrhea, nausea, abdominal pain upper |
Extreme fatigue, weakness, slept 36 hrs, stomach cramping, nausea, diarrhea, chills, muscle aches, h...
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Extreme fatigue, weakness, slept 36 hrs, stomach cramping, nausea, diarrhea, chills, muscle aches, headaches, chest pain, tachycardia up to 201, bp up to 210/101 with no cardiac history
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| 42 | 2021-01-25 | nausea |
Nausea and dropped to the floor. Nurse Alert called. Upon UC RN arrival, patient awake and alert. Ad...
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Nausea and dropped to the floor. Nurse Alert called. Upon UC RN arrival, patient awake and alert. Advised she was pregnant and having morning sickness. Tolerated juice and crackers and discharged.
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| 42 | 2021-01-25 | nausea, vomiting | Vomiting due to severe nausea |
| 42 | 2021-01-26 | diarrhea |
DEVELOPED FEVER UP TO 100.4, JOINT PAIN, DIARRHEA, WEAKNESS, AND FELT LIKE HAD A HORRIBLE FLU. TOOK ...
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DEVELOPED FEVER UP TO 100.4, JOINT PAIN, DIARRHEA, WEAKNESS, AND FELT LIKE HAD A HORRIBLE FLU. TOOK 5 DAYS TO RESOLVE. WAS PRESCRIBED AN INHALER BY PCP (UNSURE WHAT IT WAS)
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| 42 | 2021-01-26 | nausea |
Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept fo...
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Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept for 16 hours
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| 42 | 2021-01-26 | abdominal discomfort, diarrhea |
Less than an hr after the vaccine I suffered a gushing bloody nose. About 10pm I started having at ...
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Less than an hr after the vaccine I suffered a gushing bloody nose. About 10pm I started having at gurgling, discomfort feeling in my stomach which had me in the restroom all night followed by fever and diarrhea. On 12/31 I was sent for a COVID test and results on 1/1 showed that I was positive resulting in me being out of work for a total of 3 weeks. And as of today I am still experience mild COVID like symptoms
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| 42 | 2021-01-27 | nausea |
Nausea; Fatigue; Muscle/joint aches; Muscle/joint aches; Unusually sour taste in saliva in the morni...
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Nausea; Fatigue; Muscle/joint aches; Muscle/joint aches; Unusually sour taste in saliva in the mornings; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 3302), via an unspecified route of administration on 15Jan2021 07:30 in Left arm at single dose at Workplace clinic for COVID-19 immunisation. Medical history included Rhinosinusitis, Thoracic Outlet Syndrome, Polycystic ovarian syndrome (irregular menstrual cycles) and CBC issues: low white blood cell count, low lymphocyte count, high MCV (Mean cell volume) (under current care), all from an unknown date. Concomitant medication included Multivit, ergocalciferol (VIT D), folic acid (FOLIC), fish oil, magnesium, biotin. There was no other vaccine in four weeks. The patient did not have COVID prior vaccination and not had COVID tested post vaccination. The patient experienced Nausea, fatigue, muscle/joint aches and unusually sour taste in saliva in the mornings on 15Jan2021 11:00. The patient did not receive treatment for the events. The outcome of the events was recovering.
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| 42 | 2021-01-27 | diarrhea |
Pfizer-BioNTech COVID-19 Vaccine diarrhea, headache, fatigue, general feeling unwell approx. 20 ho...
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Pfizer-BioNTech COVID-19 Vaccine diarrhea, headache, fatigue, general feeling unwell approx. 20 hours post initial vaccination lasting a week and a half. Still not completely well. diarrhea x 1 and a half weeks. headache still ongoing.
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| 42 | 2021-01-27 | abdominal pain upper |
palpitations; fatigue; stomach cramping; This is a spontaneous report from a contactable consumer (p...
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palpitations; fatigue; stomach cramping; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249), via an unspecified route of administration in left arm on 11Jan2021 12:00 at single dose for COVID-19 immunization. Medical history included Congenital Heart Disease, Transposition of the Great Arteries, Mustard Procedure. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. Concomitant medication included losartan, ethinylestradiol, norethisterone acetate (JUNEL), bifidobacterium lactis (PROBIOTIC), ergocalciferol (VIT D). The patient experienced palpitations, fatigue, stomach cramping on 05Jan2021 14:00 (as reported, pending clarification) with outcome of recovering. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received.
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| 42 | 2021-01-28 | decreased appetite |
First 2 days after 2nd dose I felt chills, body aches, headache, fatigue, day 9 still extremely exh...
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First 2 days after 2nd dose I felt chills, body aches, headache, fatigue, day 9 still extremely exhausted exhausted, no appetite, body aches, unable to function for more than a few minutes at a time.
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| 42 | 2021-01-28 | nausea |
Given 1st dose of Covid vaccine on 1/5/21 and 24 weeks pregnant with hx of hypotension with pregnanc...
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Given 1st dose of Covid vaccine on 1/5/21 and 24 weeks pregnant with hx of hypotension with pregnancy. Felt nauseous and lightheaded after about 15 minutes, near syncopal episode, pallor color, taken to ED for evaluation and discharged
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| 42 | 2021-01-28 | vomiting |
Severe vomiting lasting 10.5 hours, Fever 101.7, headache, chills, hot sweats. All all lasting bet...
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Severe vomiting lasting 10.5 hours, Fever 101.7, headache, chills, hot sweats. All all lasting between 12am-10:30am. After the vomiting subsided I was able to take Tylenol for the fever and all symptoms resolved.
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| 42 | 2021-01-29 | nausea |
45 minutes after given the vaccine. Severe dizziness, stumbling, couldn't see straight, Had somewha...
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45 minutes after given the vaccine. Severe dizziness, stumbling, couldn't see straight, Had somewhat similar reaction to the first dose went down to the Emergency room on 12/31/20. They treated it as vertigo. gave zofran for nausea and valium to calm me down. Was sent home with Meclizine (motion sickness)meds. I am at 9 days after the vaccine administration and still having the vertigo and nausea due to being dizzy. I didn't go to the emergency room right away as I was treating it as they treated the first one. I fell asleep as soon as I got home from work at 130pm. I got the second dose at 0900 on 1/21/21. Fell asleep for several hours. Could barely wake up. Hands and feet were swollen. Couldn't make fists. Feet were tight. Stayed hydrated. since then for the past week I have been taking motion sickness meds the dizziness has not gone away. Went to the Emergency room on 1/28/21 as the symptoms still haven't gone away. They ruled me out for a stroke. I felt completely normal before the vaccine. I had CT scan done, MRI both came back normal. The diagnosis that was the outcome was vertigo.
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| 42 | 2021-01-29 | vomiting |
Body aches and sweats, headache, joint aches, muscle pain in the neck, fatigue and vomiting (once) ....
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Body aches and sweats, headache, joint aches, muscle pain in the neck, fatigue and vomiting (once) . My temp was up to 102. Last about 24 hours.
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| 42 | 2021-01-29 | nausea | Fever 100.8. Body aches. Headache. Fatigue. Nausea. Arm pain |
| 42 | 2021-01-30 | abdominal pain upper |
12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area...
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12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area Jan. 2 & 3: didn?t sleep well Jan. 4: mental fatigued Jan. 7: fever 101.2F, shallow breathing, upper quadrant pain, rash on neck Jan. 8: rash on abdomen; right flank pain?spoke with her Endocrinologist who think reactions are auto-immune related Jan. 15: increased blood pressure?consulted a Cardiologist and was prescribed a medication Jan. 15: had labs drawn?IgG 69 Jan. 28: consulted with a Neurologist who think she may have acute encephalitis related to the vaccine and recommended not to get the 2nd dose
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| 42 | 2021-01-30 | nausea | Chills, headache, nausea, body aches |
| 42 | 2021-01-31 | nausea | Nausea, Headache |
| 42 | 2021-01-31 | nausea, diarrhea |
Pain at injection; headache; fatigue; nausea; chills; brain fog; diarrhea; joint pain; This is a spo...
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Pain at injection; headache; fatigue; nausea; chills; brain fog; diarrhea; joint pain; This is a spontaneous report from a contactable other healthcare professional (hcp). A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), intramuscular on 18Dec2020 16:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included depression, anxiety, and known allergies to IVP dye. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications (reported as other medications in two weeks) included bupropion hydrochloride (WELLBUTRIN), sertraline hydrochloride (ZOLOFT) and unspecified multivitamin. The patient had no other vaccine in four weeks. The patient previously took cefalexin (KEFLEX) but had known allergies. On 19Dec2020 08:00 AM, the patient experienced pain at injection, headache, fatigue, nausea, chills, brain fog, diarrhea, and joint pain. No treatment received in response to the events. The patient was not tested for COVID post vaccination. The outcome of the events pain at injection, headache, fatigue, nausea, chills, brain fog, diarrhea, and joint pain was recovered on an unknown date. Information on the Lot/Batch Number has been requested.
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| 42 | 2021-01-31 | diarrhea |
Pfiser-BioNTech Covid 19 vaccine EUA Fever 99.5 , muscle aches, diarrhea & chills lasting approx. 24...
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Pfiser-BioNTech Covid 19 vaccine EUA Fever 99.5 , muscle aches, diarrhea & chills lasting approx. 24 hours
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| 42 | 2021-01-31 | nausea |
Pfizer-BioNTech COVID-19 vaccine EUA- night of 1/5/21 began having joint and muscle pain with sore ...
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Pfizer-BioNTech COVID-19 vaccine EUA- night of 1/5/21 began having joint and muscle pain with sore throat & HA. These symptoms continued and nausea, dizziness, fever and mild nasal congestion start 1/6/21
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| 42 | 2021-02-01 | nausea |
I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical obse...
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I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical observation area I experienced mild nausea that went away for the rest of the day. About an hour after the injection, I experienced nasal drainage in the back of my throat that lasted about 30 minutes. 3 hours after my shot, the arm pain at injection site began, followed by 6 hours later moderate to extreme fatigue that did not cause me to be sleepy or drowsy--simply fatigued. I had enhanced sense of taste and smell. On Wednesday, 1/27 I woke up seeming okay and tried to work at my computer from home. I experienced light-headed and dizziness, and a headache that feels like pressure, and sinus pressure at the bridge of my nose. I had to disengage from work. After lunch around 2 PM I had extreme fatigue and had to lie down in bed the rest of the afternoon and evening. I have moderate nausea that comes in goes in waves. This morning, Wednesday, 1/28 I woke up with nausea and ate breakfast with a heightened sense of smell and taste. I logged into work and the lightheadedness and dizziness began again (also sort of in waves, though the headache is more pervasive and less wave-like than the nausea), along with waves of moderate nausea and headache. The arm pain at the sight of injection has significantly abated from a punch to mild pain. The "sinus" or sinus pressure on the bridge of my nose seems only a fraction improved. The headache or pressure has moved from the back of my head to the right side of my head. I had no body aches, but this morning has mild to moderate body aches this morning in my legs and hip bones. 1/29 I woke up with 20%-30% reduced symptoms of nausea and headache, but the dizziness and sinus pressure on the bridge of my nose remain the same. I still have enhanced taste and smell (a sensory plus it's not a distorted or odd enhancement, simply the same flavors and tastes enhanced). The ache that began yesterday in my lower body, my legs still ache, though it feels more like numbness than an ache. I tried doing some stretches which felt good, but my legs still feel the same after stretching. Pain at the site of injection is reduced 90%. There are some strawberries sitting next to me, and I can smell them acutely. Yesterday, 1/30, I woke up with mild nausea and fatigue. This nausea dissipated in the morning, but I felt too fatigued to do Pilates. The waves of dizziness and waves of nausea returned mid-day and I had a low-grade fever of 99.4 (my temp. Tends to run slightly lower than 98.6, as I take it regularly). The pain/pressure in the bridge of my nose has reduced 30%, but still remains. The ache or numbness in my thighs remains the same. This morning, 1/31, my temp is normal at 98.6, but I have mild waves of nausea and moderate waves of dizziness. The pain/pressure on my nose remains the same as yesterday. I have some mild ear pressure. My thigh weakness remains the same. I am too fatigued to attempt Pilates. Acute sense of smell and taste remains the same. The headaches or pressure also seem improved since Saturday 1/30. Monday, 02/01 - ah back to work I woke up with moderate nausea and pretty intense body fatigue and muscle aches in my lower body. I had to work, and I just wanted to crawl back into bed. I worked anyway, also the fatigue tends to worsen mid-day. The dizziness is moderate in waves, and the headache is still mild, along with that mild sinus pressure on my nose. I was in bed after dinner but could have rested all day. 02/02 I awoke with a very mild nausea! The intense fatigue (which worsened several days past my vaccine) was mild. I was ready to attempt my regular Pilates routine, and I did it! My muscle aches are mild to moderate (also, why are my muscle aches mostly confined to my thighs and hips I do have vague pain at the injection site, but its vague, and I use my whole body in Pilates) dizziness waves are back as I sit here typing and get ready to login online to my job staring at the computer screen is jarring to the dizziness waves and reminds me of the mild headache. This is the best I've felt since 1/27 through mid-day I tend to worsen and dizziness that is moderate is disturbing. The heightened sense of taste and smell also seems to have waned a bit in the past two days, back to what I was per usual? I tend to have an acute sense of smell and taste. *I would like it noted in light of new evidence that many people that have had COVID are experiencing intense reactions to the first dose that it is quite likely that I had COVID back in March when my learning center (I work with students age 4-adult, some of which are learning disabled and have autism) emergency closed because a client called to say she was positive for COVID. I had taken her sons temperature the day before. Me, and my two co-workers on my management team were also feeling sick. I had a sore throat and chest pains for approx. a month, but at the time COVID testing was not widely available. Since then, My co-worker has tested positive twice for the antibodies, and her husband, who was also sick at the same time, has tested negative twice. I tested negative once for the antibodies, though given my job, my commute on the subway during rush hour my co-workers positivity, and my intense reaction to the first dose I most likely had COVID. My boyfriend's roommate recently also revealed that he is positive to the antibodies, and he was literally sneezing and coughing in the same room with us this past summer and spring. I think a 2nd dose of the same vaccine will cause fainting and vomiting, and the need for two weeks off of my work. This dizziness is alarming. I'm also thinking not having antibodies means nothing in terms of my body and immune system recognizing the vaccine and the virus, making me more ill than when and if I actually had COVID in March or last year.
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| 42 | 2021-02-03 | nausea |
(This RN was not direct observer of initial incident. Initial events as reported by initial respondi...
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(This RN was not direct observer of initial incident. Initial events as reported by initial responding RNs). Pt had just received Pfizer vaccination and was seated in observation area. Was observed to be "not looking well" and approached by staff. Pt began to hyperventilate, exhibit repetitive jerking motions to upper body/"pseudo seizure-like activity", and reported feeling nauseated. Began to slide out of chair, x2 RNs assisted pt to floor. Pt then placed in wheelchair and taken to Triage tent A. Pt remained alert and oriented throughout duration of event. VS @0915- BP 128/77 HR 131 Sats 100% on RA. 0.3mg IM epinephrine given at 0919. VS @ 0920 HR 108 0938 O2 sats 87% on RA, applied 0.5L O2 via nonrebreather mask. Sats back up to 100% @ 0939. Pt remains alert, intermittently exhibits periods of jerking actions and hyperventilation between periods of calm. With staff assist, called husband who was en route. VS @ 0940- HR 101, Sats 100% on 0.5L via nonrebreather. 50mg IM Benadryl given at 0940. VS @ 0950 HR 109 sats 100% on RA. Husband, to bedside. Pt remains alert. 1007 EMS arrives for transport to Emergency Department
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| 42 | 2021-02-03 | diarrhea | Diarrhoea |
| 42 | 2021-02-03 | decreased appetite |
Exhaustion started 2 hours after injection, the next day I had a fever of 101.4, chills, my skin hur...
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Exhaustion started 2 hours after injection, the next day I had a fever of 101.4, chills, my skin hurt, and no appetite. The fever broke over night. The following day I had hardly any appetite, brain fog, and exhaustion.
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| 42 | 2021-02-03 | abdominal pain upper, diarrhea, abdominal discomfort |
Fatigue - within one hour Injection site soreness - 4 hours later Upset stomach/stomach pain/diarrh...
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Fatigue - within one hour Injection site soreness - 4 hours later Upset stomach/stomach pain/diarrhea- within four hours, still present after 23 hours
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| 42 | 2021-02-03 | nausea |
Fever / Chills / Headache / Nausea all started on the same day as vaccine around 7pm. Resolved after...
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Fever / Chills / Headache / Nausea all started on the same day as vaccine around 7pm. Resolved after 36hours. On 1/29 noticed rash from mid neck to shoulder to upper torso, breast, ears. Red and splotchy but not itchy. Rash resolved by 1/30 after a dose of Benadryl.
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| 42 | 2021-02-03 | nausea |
Flu like symptoms first 2 days: body and headaches, nausea. Tuesday, Wednesday felt better. Thursda...
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Flu like symptoms first 2 days: body and headaches, nausea. Tuesday, Wednesday felt better. Thursday 101.0 fever
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| 42 | 2021-02-03 | decreased appetite, nausea | Headache- migrane, chills, muscle soreness, lethargy/ tiredness, lack of appetite/ nausea |
| 42 | 2021-02-03 | nausea | NAUSEA, BACK ACHE, BODY ACHES, PAIN AND SORENESS |
| 42 | 2021-02-03 | nausea |
severe body aches; site of injection severely sore; low grade fever; nausea; joint pains; felt terri...
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severe body aches; site of injection severely sore; low grade fever; nausea; joint pains; felt terrible like hit by a truck; This is a spontaneous report from a contactable other healthcare professional reporting for a patient. A 42-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular at the right arm on 19Jan2021 14:30 at single dose for Covid-19 immunization in a hospital. Medical history was none. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included first dose of BNT162B2 via unspecified route of administration at the left arm on 31Dec2020 for Covid-19 Immunization and experienced had small joint pain on unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 16:45 (within 3 hours of getting the 2nd shot), the patient experienced severe body aches, site of injection severely sore, low grade fever, nausea, joint pains, felt terrible like hit by a truck. The patient has not been tested for COVID-19 since the vaccination. The patient took Tylenol and didn't work. The outcome of the events severe body aches, site of injection severely sore, low grade fever, nausea, joint pains, felt terrible like hit by a truck was not recovered. The events were considered non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.
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| 42 | 2021-02-04 | nausea | Pain in arm Pain in shoulders and neck Very bad nausea Vomited once Fatigue |
| 42 | 2021-02-04 | diarrhea, nausea |
Vaccine 1: flu like symptoms, severe headache, rash, severe body aches, fatigue for about 4 days. V...
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Vaccine 1: flu like symptoms, severe headache, rash, severe body aches, fatigue for about 4 days. Vaccine 2: Nausea, diarrhea, fatigue, severe body and muscle and joint aches, headache, temporary loss of taste and smell again. Lasted about 30 hours. Diarrhea persisted for 6 days.
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| 42 | 2021-02-06 | nausea |
Patient complained of headache, nausea, dizziness, and burning sensation on upper lips 10-15 minutes...
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Patient complained of headache, nausea, dizziness, and burning sensation on upper lips 10-15 minutes post-injection.
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| 42 | 2021-02-07 | diarrhea, abdominal pain upper, vomiting, nausea |
12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. ...
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12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. Itching and erythema. Ears began to swell and became hot and red. Face and neck uncomfortable. Took Benadryl when went to bed at midnight. 1-1-2021 In evening began severe itching and erythema form head to breasts including arms which lasted three hours. Right eat internal soreness. 1-2-2020 Fifteen minutes after eating began sudden stomach crapms and then larger amounts of diarrhea and vomiting. Later had another episode of vomiting and diarrhea. Felt weak with labored breathing, chills, Fever 100.2, another bout of diarrhea and vomiting. Productive cought that started in the evening with clear mucous.
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| 42 | 2021-02-07 | nausea, diarrhea | 1st Vaccine 1/8/2021; 2nd Vaccine 1/29/2021; seen at ICC for Diarrhea, nausea onset 1/30/2021 |
| 42 | 2021-02-07 | difficulty swallowing |
Client reports that she was feeling weird and was not a panic attack as she has had them before. Sh...
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Client reports that she was feeling weird and was not a panic attack as she has had them before. She states that she was lightheaded, dizzy and that her tongue started to well and she couldn't swallow. Client reports that she received Benadryl, and anti nausea medication. Client was transported to the local hospital. Client states that she could still breath through her nose and that she was only in the ER for approximately 2.5 hours.
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| 42 | 2021-02-07 | diarrhea, nausea |
Patient returned at 9:36am after receiving first dose at 8:41 complaining of nausea and dizziness. ...
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Patient returned at 9:36am after receiving first dose at 8:41 complaining of nausea and dizziness. Vital signs taken and assessment determined Benadryl needed. Patient was given 0.4mL =(20mg) . Patients vitals checked every 5 minutes. At 10:16 patient felt better and reposted symptoms better and no dizzy spells. Pt released at 10:38. Patient called for update on 2/5/21. Patient reported feeling better this day but reports that nausea returned with cramping and lasted until 2:30 pm day of shot. Dizziness and confusion lasted until 9:00pm day of injection, disoriented until 6pm day of injection and diarrhea that lasted until 4pm day of injection. Per medical director, Dr, patient should not get second dose of Pfizer vaccine.
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| 42 | 2021-02-09 | diarrhea | Extream all over muscle aches, headache, diarrhea, light-headedness |
| 42 | 2021-02-17 | vomiting, diarrhea |
Itching and feeling off over a week post second dose. The following day I was extremely tired and we...
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Itching and feeling off over a week post second dose. The following day I was extremely tired and weak. By that evening, day 9 or 10, I began vomiting followed by horrible diarrhea that lasted about 12 hours. I never thought it was related to the vaccine until I heard from others that had the same symptoms days after their vaccine.
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| 42 | 2021-02-17 | abdominal pain upper |
smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had ...
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smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had been/pain was in her scapula, her left arm, all of her joints; pain was in her scapula, her left arm, all of her joints; could feel her blood surging through her body; she couldn't get comfortable; Crying; Allergic reaction; body aches; dizziness; hallucinations; up all night; exhausted/ fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9261), via an unspecified route of administration at the right arm on 22Jan2021 14:58 at a single dose for COVID-19 vaccination and ketorolac tromethamine (TORADOL), via an unspecified route of administration on 22Jan2021 16:30 at an unknown dose, single for pain. The patient medical history includes low iron anemia from Oct2020 and allergy to eggs, pecans, walnuts and latex. Also on 15Jan2021, she fell down the stairs and thought she broke her arm and was in severe pain. The has been taking iron supplements as concomitant medications. The patient reported having hallucinations, body aches, fatigue and dizziness on Jan2021. On 22Jan2021 09:00PM, she started smelling smoke, like cigarette smoke, like her home was filling with cigarette smoke, and no one in her house even smokes. On 22Jan2021, she also had severe stomach cramps like she was going to have diarrhea, but she never did. She says she was bowed over with the worst cramps like menstrual cramps, and her left arm was in pain, more pain that it had been. She says she could feel blood surging in her legs, it was almost surreal, she could feel the blood going through her body, which she never had felt something like that before. She says that the pain was in her scapula, her left arm, all of her joints. She says she could not get comfortable, and she was crying she was in that much pain. She says she does not typically cry and has a pretty good pain tolerance. She says she was getting freaked about that, and the next morning she was exhausted (Jan2021), she would assume since she was up all night in pain (Jan2021). The following day she laid around and felt extremely fatigued and dizzy, then by Sunday she was feeling better. For pain treatment she took Ibuprofen though her doctor also prescribed her another pain pill for her arm, she was scared to take it, so she took Ibuprofen 600mg which was also prescribed to her. The patient said that she did not think it was an allergic reaction but her doctor thought it might have been. The action taken in response to the events for ketorolac tromethamine was unknown. The outcome of the events was unknown.
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| 42 | 2021-02-18 | difficulty swallowing |
could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; ...
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could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
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| 42 | 2021-02-21 | nausea |
Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after i...
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Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after injection, headache and some fatigue-took Ibuprofen 36 hours after injection, migraine, arm pain, fatigue, nausea-took flexiril, Zofran, and Ibuprofen 48 hours after injection, fever of 101, armpit pain, arm pain, fatigue-took Ibuprofen 72 hours after injection arm swollen in 3"x5" oval, bright red, hot to touch, armpit very tender, mild headache-took Ibuprofen
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| 42 | 2021-02-22 | nausea |
Approx. 10 minutes after receiving 2nd dose of vaccine, client stated she felt nauseous and light he...
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Approx. 10 minutes after receiving 2nd dose of vaccine, client stated she felt nauseous and light headed. BP 142/98, P 100 at 10:16am. Placed on floor with head down/feet elevated. Ice packs applied to neck. Given water to drink. Monitored for 30 minutes with no improvement. BP 112/80 P 80 @ 10:46am. Squad called to transport to ER.
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| 42 | 2021-02-22 | vomiting | Second vaccine 02/19/2021 1150, first vaccine 01/29/2021@1150; Headache, aching and vomited once |
| 42 | 2021-02-23 | nausea |
02/13/2021: sore left arm, extreme fatigue started in afternoon 02/14/2021 - 02/15/2021: muscular pa...
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02/13/2021: sore left arm, extreme fatigue started in afternoon 02/14/2021 - 02/15/2021: muscular pain, headache, exhaustion, slight nausea, joint pain 02/16/2021 - 02/17/2021: extreme fatigue, joint pain 02/18/2021 - 02/24/2021: fatigue, joint pain (7 on a scale of 1-10)
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| 42 | 2021-02-23 | nausea |
per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that...
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per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that after her second dose she experienced facial swelling, hives, chest pain , joint pain and feels tingling in her body
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| 42 | 2021-02-24 | diarrhea, decreased appetite, nausea, abdominal pain upper |
tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appet...
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tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-25 | nausea |
13:10-Patient on gurney in observation after vaccine for hx of nausea/lightheadedness with 1st dose ...
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13:10-Patient on gurney in observation after vaccine for hx of nausea/lightheadedness with 1st dose of vaccine x 1.5 days. PMHx: HTN, Gastroparesis, IBS Meds: Flagyl, Glyburide VS: B/P-148/110, RR 16, SaO2: 96% on RA, CBG: 133 1327 repeat VS: B/P-138/104, RR 16, HR 90, SaO2: 98% on RA Cool cloths to neck and forehead with HOB flat. Slight improvement. Daughter accompanied patient today is able to drive her home. 1415: patient released by Provider on duty and EMS. Patient educated to follow up if her symptoms should worsen. Patient communicated understanding at time of discharge home with daughter.
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| 42 | 2021-02-25 | nausea |
13:50- Approximately 5 minutes after vaccine administered pt became flushed, nauseated and c/o light...
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13:50- Approximately 5 minutes after vaccine administered pt became flushed, nauseated and c/o lightheadedness. Patient alerted observer and medical assistant called for transfer of the patient to the first aide office. Patient then evaluated by EMS on duty: VS: b/p 142/80, SaO2 100% on RA. PMHx: Migraines Medications: Fiornial, patient had same s/sx after 1st vaccine. 1435: Patients symptoms resolved and patient was cleared by EMS to discharge home. Ambulated on own without weakness. Escorted out by Paramedic to car.
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| 42 | 2021-02-25 | vomiting, diarrhea, nausea |
1st vaccine 1/31/21; 2nd vaccine 2/21/21; developed N/V/D, HA, chills onset 2/21/21 after vaccine; s...
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1st vaccine 1/31/21; 2nd vaccine 2/21/21; developed N/V/D, HA, chills onset 2/21/21 after vaccine; seen at ICC 2/26/21 for ongoing symptoms; sent to ED from ICC 2/26/21 for treatment of symptoms.
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| 42 | 2021-02-25 | nausea |
Patient after receiving her vaccine stated she felt dizzy and lightheaded with nausea immediately. ...
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Patient after receiving her vaccine stated she felt dizzy and lightheaded with nausea immediately. Patient taken to first aide area for assessment. Patient is A & O x3, Skin Pink warm and dry and patient appeared in no apparent distress. Patient states she has a history of migraines. Patients VS were: B/P 130/66, HR 89, SaO2 of 95% on RA. Patient stated that she did have a headache with 6/10 pain and states her last migraine was last one week ago with no aura. Patient discharged home after full 30 minute wait without complications and return to baseline.
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| 42 | 2021-02-25 | difficulty swallowing |
felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; diff...
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felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; difficulty swallowing; hard time thinking and talking normal; hard time thinking and talking normal; This is a spontaneous report from a contactable consumer (patient) A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en9815) on 11Feb2021 at 15:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included congenital adrenal hyperplasia and slight lactose intolerance. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), prednisone and naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]). On 11Feb2021 patient experienced dizzy, felt like she was to pass out, brain fog/hard time thinking and talking normal, tightness of chest and throat, difficulty swallowing. Events resulted in visit to emergency room. The latter 2 events continued to get worse so they gave the patient an epinephrine injection (reported as EPI shot). Benadryl IV was also administered. At the time of the reporting the patient was recovering from reported events.
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| 42 | 2021-02-26 | abdominal discomfort |
extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very...
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extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very strong have had it all week intermittently. Shaky, racing heart, high BP all intermittent, gastrointestinal upset, headache, feeling run down, trouble breathing but lungs fine Disruptive to working, thinking daily life feel very weird on and off
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| 42 | 2021-03-02 | diarrhea |
Bad headache; pain at location of injection; diarrhea; This is a spontaneous report from a contactab...
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Bad headache; pain at location of injection; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number E13302), via an unspecified route of administration (arm right) on 15Jan2021 11:30 SINGLE DOSE for covid-19 immunisation, at 42 years old. Medical history reported as none. The patient is not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has no reported allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE), therapy date and indication unknown (received withing 2 weeks). The patient experienced bad headache lasting over 24 hours, pain at location of injection for two days, and diarrhea on 15Jan2021 11:30. Treatment was not given. Outcome of the events was recovered on Jan2021. The reporter considered the events as non-serious.
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| 42 | 2021-03-02 | vomiting |
Extreme muscle aches; fever; chills; headache; vomiting; This is a spontaneous report from a contact...
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Extreme muscle aches; fever; chills; headache; vomiting; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 29Jan2021 17:15 (at the age of 42-years-old) at single dose for COVID-19 immunization in the workplace clinic. Medical history included endometriosis, acid reflux, and history of blood clots. The patient had no known allergies. The patient was not pregnant. The patient did not have COVID prior to vaccination. Concomitant medication included methyldopa hydrochloride (ALDOMET [METHYLDOPA HYDROCHLORIDE]), omeprazole (PROTONIX [OMEPRAZOLE]), probiotics (PROBIOTICS), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and vitamins. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in the left arm on 08Jan2021 at 06:15 PM (at the age of 42-years-old) for COVID-19 immunization. The patient did not receive other vaccines in four weeks. The patient experienced extreme muscle aches, fever, chills, headache, vomiting on 30Jan2021 at 11:00 AM. The patient did not receive treatment for the events. The patient was not tested for COVID post vaccination. The outcome of the events was recovered in Jan2021. Information on the Lot/Batch number has been requested.
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| 42 | 2021-03-03 | retching |
First dose I was exhausted, body aches, high fever and headache. The 2nd dose I had dry heaves and h...
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First dose I was exhausted, body aches, high fever and headache. The 2nd dose I had dry heaves and headache.
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| 42 | 2021-03-03 | nausea |
Light headed and very dizzy. I had came back to work. I got severely tired. I went home to bed. For ...
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Light headed and very dizzy. I had came back to work. I got severely tired. I went home to bed. For the next 2 days I was weak, headache, light headed, dizzy, couldn't concentrate. Nausated. I had covid in November 2020 and it was some of the symptoms I had then. I am very worried about the second shot
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| 42 | 2021-03-03 | nausea |
nausea, no vomiting. feeling flush, shakey, and anxious. No SOB, pruritis. Moved to a quiet room. ...
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nausea, no vomiting. feeling flush, shakey, and anxious. No SOB, pruritis. Moved to a quiet room. Lay down for 45 minutes and observed. symptoms spontaneously subsided.
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| 42 | 2021-03-04 | abdominal pain, diarrhea |
Diarrhea; severe abdominal pain; This is a spontaneous report from a non-contactable nurse. A 42-yea...
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Diarrhea; severe abdominal pain; This is a spontaneous report from a non-contactable nurse. A 42-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer COVID-19 vaccine; lot number: EN5318; expiration date: unknown) at vaccination age of 42-year-old via an unspecified route of administration in the right arm on 31Jan2021 at a single dose for covid-19 immunization. Medical history included Pcos (polycystic ovaries). The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no known allergies. Concomitant medication included unspecified medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 (BNT162B2 reported as Pfizer COVID-19 vaccine; lot number: EL3246; expiration date: unknown) at vaccination age of 42-year-old intramuscular in the left arm on 11Jan2021 09:00 AM at a single dose for covid-19 immunization. The patient received the most recent COVID-19 vaccine in a hospital. On 01Feb2021 12:00 PM, the patient had diarrhea and severe abdominal pain staring 24 hours post second vaccine which lasted for 24 hours. The patient did not receive treatment for the adverse events. The patient has not been tested for COVID-19 since vaccination. The events were non-serious. The outcome of the events was recovered on 02Feb2021 12:00. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-03-04 | abdominal pain upper, nausea, diarrhea, abdominal distension |
Sever GI issues. They have continued for 8 days now. I'm allergic to ALL seafood, and the symptoms I...
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Sever GI issues. They have continued for 8 days now. I'm allergic to ALL seafood, and the symptoms I'm experiencing remind me of those: bloody sto, diarrhea, nausea, bloating, stomach cramping. The symptoms started about 30 minutes after the vaccine was administered. It took me this long to figure out it may have been the vaccine. (The above is my main concern. I did also experience a stiff and painful arm which limited my range of motion, and fever. But I expected those reactions. )
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| 42 | 2021-03-04 | diarrhea, nausea |
The next day of the vaccine on 1/13/2021 around 4am I had fever, chills, body aches, joint aches, na...
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The next day of the vaccine on 1/13/2021 around 4am I had fever, chills, body aches, joint aches, nauseous, fatigue, headaches & I had diarrhea for 1 day. All my symptoms lasted for about 3 days except the body aches they lasted for about 5 days. I called my primary doctor he prescribed me antibiotics. After a week is when I felt normal.
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| 42 | 2021-03-07 | nausea |
Fever; chills; soreness at injection spot; body and joint aches; body and joint aches; headache; nau...
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Fever; chills; soreness at injection spot; body and joint aches; body and joint aches; headache; nausea; eye ache and watery; eye ache and watery; This is a spontaneous report received from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9267, expiry date: unknown), via an unspecified route of administration in the left arm, on 13Feb2021 09:30, at single dose, for COVID-19 immunization, at the hospital. There were no medical history and concomitant medications. The patient has no allergies to medications, food, or other products and was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9261, expiry date: unknown) received at 42 years of age, via an unspecified route of administration in the left arm, on 23Jan2021 09:30, at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 13Feb2021 at 18:00, the patient experienced fever, chills, soreness at injection spot, body and joint aches, headache, nausea, and eye ache and watery. No treatment was given for the events. The patient recovered on an unspecified date in Feb2021. The reporter assessed the events as non-serious. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-03-14 | difficulty swallowing |
Severe pain in my left jaw; it (jaw) locked up/face froze; difficulty swallowing; This is a spontane...
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Severe pain in my left jaw; it (jaw) locked up/face froze; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202), via an unspecified route of administration in the left arm on 25Feb2021 14:00 at a single dose for COVID-19 immunisation. The patient's medical history included diagnosed with COVID-19. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but had other unspecified medications within 2 weeks of vaccination. On 25Feb2021 20:00, the patient experienced severe pain in her left jaw then it (jaw) locked up. Her face froze. She had difficulty swallowing. The patient had not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of the events and included treatment with muscle relaxer, heat and ice, and rest. Outcome of the events was not recovered.
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| 42 | 2021-03-14 | diarrhea, nausea |
unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Lo...
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unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-03-15 | vomiting, nausea | n/v, chills, SOB, pulmonary embolism, pericardial effusion |
| 42 | 2021-03-21 | nausea |
Cold feet in the evening when vaccine was given. 1AM woke up with chills that continued through the...
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Cold feet in the evening when vaccine was given. 1AM woke up with chills that continued through the next day. Extreme body aches that started in the middle of the night that continued into the next day. Extreme headache which made me nausea until 5PM the next day. Felt 100 percent better on Sunday at 1PM. Vaccine was given on Friday at 1PM.
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| 42 | 2021-04-01 | nausea, diarrhea, abdominal pain upper, abdominal distension |
bloody stool; diarrhea; nausea; bloating; stomach cramping; This is a spontaneous report from a cont...
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bloody stool; diarrhea; nausea; bloating; stomach cramping; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Feb2021 at 18:00 (at the age of 42 years-old), as single dose for covid-19 immunization. Medical history included diabetes, hypothyroidism, palindrome rheumatoid and known allergies with seafood. Patient is not pregnant at the time of report and at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination (unspecified date), the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient was taking several daily prescription medications. On 25Feb2021 18:30, patient experienced severe GI issues: bloody stool, diarrhea, nausea, bloating and stomach cramping. Symptoms have continued for 8 days now. Patient stated, "It took me this long to figure out it may have been the vaccine". The outcome of events was not recovered. Patient did not receive any treatment for the events. Follow-up attempts are completed. The following information on the batch number has been requested.
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| 42 | 2021-04-02 | diarrhea |
like blurry vision and then she lost her senses/loss of consciousness (fainting)/passed out; like bl...
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like blurry vision and then she lost her senses/loss of consciousness (fainting)/passed out; like blurry vision and then she lost her senses/loss of consciousness (fainting); tachycardia; mental confusion; loss of sphincter control (urinary incontinence)/pissed on herself; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 15Mar2021 13:15 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the pharmacy. Medical history was not reported. There were no concomitant medications. The patient was not pregnant (including at the time of vaccination). On 16Mar2021 13:15, she came around to feeling really something bad in her body. She described this as she had loss of consciousness (fainting) which started to feel like blurry vision and then she lost her senses. She then passed out for 5-8 minutes and she had loss of sphincter control (urinary incontinence) as she pissed on herself. She also had tachycardia and mental confusion by that time. They called an ambulance and she was brought to the emergency or urgency department/room. The events [loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion] were considered as serious (medically significant). She also had several diarrhea (noted in 2021) episodes during one week. She had no COVID prior vaccination and not tested post vaccination. She would like to know if the reaction that she had with first dose vaccination was normal as she was afraid of the second one. The patient did not receive any treatment for the events of loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion. Outcome of the event of diarrhea was unknown while recovering for the remaining events. Information on the lot/ batch number has been requested.
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| 42 | 2021-04-03 | diarrhea |
retested and was found positive; COVID-19 virus test positive; ear infection; sinusitis; Watery diar...
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retested and was found positive; COVID-19 virus test positive; ear infection; sinusitis; Watery diarrhea; feeling sick; The following day I woke up with sinus congestion; Intense muscle aches; Headache; I began with a cough that night; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 17Mar2021 (Batch/Lot Number: Er8727) as SINGLE DOSE; and first dose via an unspecified route of administration, administered in Arm Left on 22Feb2021 09:00 AM (Batch/Lot Number: En6200); both for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient is not pregnant at the time of vaccination. The patient was vaccinated at Public Health department (also reported as Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (reported as List of any other medications the patient received within 2 weeks of vaccination) included benazepril, hydrochlorothiazide, protonix, oxymetazoline hydrochloride (CLARITIN ALLERGIC) and Methotrexate; all taken for an unspecified indication, start and stop date were not reported. The patient reported that: "On 14Mar2021 at 10:00 PM, I began with a cough that night. The following day (15Mar2021) I woke up with sinus congestion, cough, muscle aches and headaches. The following day the same. I tested negative that day (Nasal Swab on 16Mar2021). The following day (17Mar2021) I received my 2nd dose of vaccine still feeling sick and cough which I informed PH nurse of. Later that night still same symptoms but with watery diarrhea. No stomach cramps or pain to indicate diarrhea. I went the following day (18Mar2021) to my physician and was told I had ear infection and sinusitis. I was given meds. Yesterday morning I woke up with intense muscle aches and headache. I retested and was found positive (Nasal Swab) on 19Mar2021." The outcome of the events was not recovered. It was reported that treatment were received for the adverse event which includes: Amoxocillin, Flonase, albuterol and promethazine. The events resulted Doctor or other healthcare professional office/clinic visit. Further information needed, further information expected.
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| 42 | 2021-04-05 | abdominal pain upper, appendicitis, vomiting |
Began throwing up around 6:00 until 8:00 PM. Then turned into severe stomach pain. Went in on Satu...
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Began throwing up around 6:00 until 8:00 PM. Then turned into severe stomach pain. Went in on Saturday morning at 10:00 to the ER. They admitted me into the hospital for EMERGENCY SURGERY TO REMOVE MY APENDIX. Appendicitis. Never any issues before. I did research, there have been 7 other people with such severe reactions thus far.
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| 42 | 2021-04-09 | nausea |
fainting; nauseous; I hit my head and chin on the dresser; I hit my head and chin on the dresser; I ...
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fainting; nauseous; I hit my head and chin on the dresser; I hit my head and chin on the dresser; I hit my head and chin on the dresser/seven stitches in my chin; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ER8727) via an unspecified route of administration, administered in left arm on 25Mar2021 09:00 as single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant and no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included hair vitamins, and tru metabolism in which the patient received within 2 weeks of vaccination. The patient received first dose of bnt162b2 for Covid-19 immunization on 04Mar2021, 09:30. On 26Mar2021, the patient reported that she went to use the restroom around 0300 am as she was feeling nauseous. The next thing she remembered was being woken up on the floor of her bedroom by her husband. As a result of fainting, she hit my head and chin on the dresser. This resulted in needing seven stitches in her chin. The events resulted in emergency room/department or urgent care and therapy included stitches, x-rays, EKG and urine test on an unspecified date with unknown results. Outcome of events was recovering.
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| 42 | 2021-04-20 | nausea |
life stopping migraine; tighten muscles around the back of my neck and shoulder muscles; VERY nausea...
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life stopping migraine; tighten muscles around the back of my neck and shoulder muscles; VERY nauseated; small fever; be cold; chills; soaked in sweat; This is a spontaneous report from a contactable consumer(patient). A 42-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 13Mar2021 (Batch/Lot Number: F(E)N6208) as SINGLE DOSE for covid-19 immunisation. The patient was not pregnant. Medical history included Stroke, anorexia, gastroparesis, asthma, thyroid, low BP, hypotension, known allergies -Sulfa, Paxil, Demerol. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 09Feb2021 10:30 AM (Batch/Lot Number: EM9809 as SINGLE DOSE for covid-19 immunisation. Concomitant medications received within 2 weeks of vaccination included Fentanyl patch, seroquel, trazodone, ambien, baclofen. The patient previously took paxil and experienced known allergies-sulfa, demerol and experienced known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 14Mar2021 at 04:00, the patient experienced life stopping migraine, tighten muscles around the back of my neck and shoulder muscles, very nauseated, small fever, be cold, chills, soaked in sweat. The patient did not receive any treatment for the events. Outcome of all the events was recovered with sequelae. Information on Lot/Batch number was available. Additional information has been requested.
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| 42 | 2021-04-24 | decreased appetite |
Fever of 102; chills; temperature swings hot/cold; sweating; Exhaustion; no appetite; entire arm ext...
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Fever of 102; chills; temperature swings hot/cold; sweating; Exhaustion; no appetite; entire arm extremely sore; This is a spontaneous report from a contactable consumer (patient). A 42-Year-old female patient received received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 05Apr2021 at 13:30 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 15Mar2021at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 06Apr2021 at 11:30 AM, the patient experienced fever of 102, chills, temperature swings hot/cold, sweating, Exhaustion, no appetite, entire arm extremely sore. No treatment was received. The outcome of the events was recovered. Information on the lot/batch number has been requested.
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| 42 | 2021-04-24 | diarrhea |
diarrhea; she tested positive for Covid-19; she tested positive for Covid-19 with fever; This is a s...
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diarrhea; she tested positive for Covid-19; she tested positive for Covid-19 with fever; This is a spontaneous report received from a contactable nurse (patient herself). A 42-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number/Expiration date: EK5730/Unknown) via an unspecified route of administration in the left arm on 19Dec2020 and second dose (lot number/expiration date: EL1283/Apr2021) via an unspecified route of administration in the left arm on 07Jan2021 at 18:00 (at the age of 42-year-old) as a single dose for COVID-19 immunization at Hospital. Medical history included ongoing Ulcerative colitis from 1997. Patient prior vaccination included flu shot, had a little neuropathy from the flu shot the last couple of times that she received it and the last flu shot was in 2018. Concomitant medications included adalimumab (HUMIRA) at an unspecified dose once weekly from 2008 still ongoing for Ulcerative colitis and was taking immunosuppressants to treat and rabeprazole sodium (ACIPHEX) at a dose of 20 mg once daily (reported as probably 4 years ago) still ongoing for reflux. Patient was a non-smoker. Patient reported that she works in health care and has a daughter with special needs, and she wanted to protect herself so that she did not become a vector for her daughter, and she was definitely symptomatic for Covid-19 and reported that she ran a fever, her highest temperature was 102.6 and stated that she thinks that it's been coming down considerably every day. On 08Apr2021, patient temperature was 100. On 08Apr2021, patient had COVID-19 PCR test and tested positive after receiving both doses of vaccine. It was unknown that patient had SARS-CoV2 antibodies at diagnosis. On 09Apr2021, her temperature was 99. The patient did not require supplemental oxygen or mechanical ventilation and patient did not have multiorgan failure, respiratory, cardiovascular, vascular, renal, neurological, hematological, dermatological symptoms but had gastrointestinal/hepatic symptoms of diarrhea issues but she has been having ulcerative colitis issues and she would not say that the diarrhea issues started when she got sick. The patient did not receive any additional therapies or initiation of a new medication or other treatment or procedure for Covid-19. The outcome of the event she tested positive for Covid-19 was recovering and for diarrhea was unknown.; Sender's Comments: The contributory role of the suspect product to reported events is possible.
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| 42 | 2021-04-26 | abdominal pain upper, vomiting, diarrhea |
upper stomach pain; chills; vomiting all night and diarrhea; vomiting all night; severe back ache; T...
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upper stomach pain; chills; vomiting all night and diarrhea; vomiting all night; severe back ache; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER8730), via an unspecified route of administration, administered in the left arm on 01Apr2021 at 12:00 as a single dose for COVID-19 immunization. Medical history included colitis from an unknown date and unknown if ongoing. Concomitant medication included mesalamine (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccines in four weeks. The patient was tested for COVID-19 with a nasal swab on 04Apr2021 with a result of negative. On 01Apr2021 at 06:00 PM, the patient started to have severe back ache. The patient took Aleve and it didn't go away. The patient then had dinner and took Tylenol extra strength and tried to sleep. The patient took Benadryl to go to sleep as the pain was unbearable. The next day, 02Apr2021, the patient was fine until 09:30 PM. The unbearable backpain came back and the patient also had upper stomach pain. The patient had chills, no fever, vomiting all night and diarrhea. The pain never went away. By Sunday, 04Apr2021, the patient went to the hospital in the emergency room and her gallbladder was removed. The patient was hospitalized on 04Apr2021, for two days, due to the events. The outcome of the events was recovering.
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| 43 | 2021-01-03 | nausea, vomiting |
On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea...
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On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea/vomiting. Patient saw MD on 12/30/2020, MD stated patient had inflammatory response to the vaccine. Patient received a steroid injection. Patient states she feels better after steroid injection.
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| 43 | 2021-01-03 | nausea |
She suspected that she had an undiagnosed autoimmune disease.; Spinal pain that elicits nausea; spin...
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She suspected that she had an undiagnosed autoimmune disease.; Spinal pain that elicits nausea; spinal pain that elicits nausea; Headache that is worse at night/Headache worse at night time, sometimes gets better during the day/bad head ache; Body aches; Feeling crappy; Low grade fever; Pressure in the head; Terrible pain; Neck pain; This is a spontaneous report from a contactable other health professional (patient). A 43-yearsold female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received Covid19 vaccine on 19Dec2020 and reported that at 36 hours she had body aches, feeling crappy, and low grade fever in Dec2020, she had since developed at headache that is worse at night, and spinal pain that elicits nausea. She suspected that she had an undiagnosed autoimmune disease. She was inquiring about duration of the reported AE's from clinical trials, and tried to decide how long she will feel this way. And going on 10 days and she's just struggling, bad headache and neck pain headache worse at night time, sometimes gets better during the day. Terrible pain and nausea. Any info on length of side effects: 36 hours- body aches feeling crappy. Low grade fever. Nausea with the spinal pain, pressure in the head. Difference in people with autoimmune issues- infertility - suspected autoimmune. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, there is no biological plausibility to implicate the suspect vaccine to the occurrence of the serious event autoimmune disease. More information such as medical history and concomitant medications and confirmative diagnostic workups are needed for full medial assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-04 | nausea | Dizziness, nausea, light headedness, palpitations |
| 43 | 2021-01-04 | decreased appetite, nausea |
No appetite; congested head; congested head, cough; headache; fatigue; nausea; about an hour after f...
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No appetite; congested head; congested head, cough; headache; fatigue; nausea; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; This is a spontaneous report from a contactable other health care professional. A 43-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 18Dec2020 11:00 at single dose at arm (pending clarification) for COVID-19 immunization. Medical history included asthma, allergies, depression, penicillin allergy, allergies to: Mangoes, Cashews, Peaches. Concomitant medications included sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took amoxicillin and experienced known allergies: Amoxicillin. On 18Dec2020: about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant. Lasted about an hour. On 19Dec2020: afternoon - headache, nausea, fatigue started. On 20Dec2020: continued to feel fatigued and same symptoms. On 21Dec2020: headache, waves of nausea along with feeling flush (no fever ever) and elevated heart rate. On 22Dec2020: Same. The patient continued to work through all this but felt lousy. On 23Dec2020: stayed home from work because work wanted the patient to take a Covid Test (this was negative) - so laid around. Still with headache and nausea, easily fatigued. Cough started PM. On 24Dec2020: no nausea but continued headache, congested head, cough. On 25Dec2020: feeling better. No appetite. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, and was negative on 23Dec2020. The outcome of the events was recovered. The patient did not receive treatment for the events. Information about lot/batch number has been requested.
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| 43 | 2021-01-04 | abdominal pain |
Restricted respiration , muscle ackes and pain on my body, severe menstrual cramps from my abdomen t...
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Restricted respiration , muscle ackes and pain on my body, severe menstrual cramps from my abdomen to my armpit ( new and not experienced before).
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| 43 | 2021-01-04 | nausea |
fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was ...
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fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was something hot going through my body; She said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot.; It made it hard to breathe; felt like a rush of hot and felt horrible; My heart rate and BP was high; My heart rate and BP was high; she looked pale, and did not have rashes; This is a spontaneous report from a contactable Other HCP reporting for herself A 43-years-old female patient received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 26Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included thyroid cancer from 2009 , blood calcium decreased from an unknown date , depression from an unknown date , anxiety from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC) [fluoxetine (FLUOXETINE), calcium carbonate, colecalciferol, menaquinone (VITAMIN K2 + VITAMIN D3 + CALCIUM), calcium carbonate (TUMS) vitamin C (VITAMIN C) , vitamin D2 (VITAMIN D2), levothyroxine sodium (SYNTHROID). On 26Dec2020, about thirty minutes after receiving the vaccine the patient suddenly felt there was something hot going through her body it made it hard to breathe , felt like a rush of hot and felt horrible , her heart rate and BP were high, she said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot. , she looked pale, and did not have rashes. The patient believed she was having an allergic reaction and gave a shot of epinephrine before going to ER. The doctors told her that her oxygen was fine (SatO2: 98%) and therefore she was not having an allergic reaction. She felt like she had trouble breathing. Her heart rate would go up to 120 to 150. Her blood pressure was high. She also received a shot of lorazepam (ATIVAN) at about 15:30 on 26Dec2020. She went bed and woke up on 27Dec2020, she had fever at 99.4°F and had nausea. The outcome of the reported events was unknown. The patient stated this was a terrible experience and she felt like she was going to die. Also she is not going to receive the second shot of the vaccine.
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| 43 | 2021-01-04 | diarrhea |
had occasional diarrhea for about 24 hours, got shot on 12/21/2020 and had diarrhea 4 times on 12/22...
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had occasional diarrhea for about 24 hours, got shot on 12/21/2020 and had diarrhea 4 times on 12/22/2020, also felt tired.
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| 43 | 2021-01-04 | diarrhea |
sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I cou...
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sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I could barely keep my eyes open for three days; mild headache; menstrual cramps; diarrhea; I had bizarre dreams like being attacked by zombies for three days; chills; This is a spontaneous report from a contactable pharmacist. A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration at Left arm on 23Dec2020 17:45 at single dose for covid-19 immunization. Patient known allergies included Imitrex, beef, grass, weeds, trees, Cats. Other medical history included Asthma, allergies, migraine, Premenstrual syndrome (PMS), overweight. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received other medications in two weeks. The COVID-19 vaccine was administered at Hospital. The patient experienced extreme fatigue. Her arms felt like lead for three days, and she felt so sleepy. She felt like she could barely keep her eyes open for three days. She had a mild headache. It triggered menstrual cramps and diarrhea for three days. She had bizarre dreams like being attacked by zombies for three days. She had chills for a few hours. She had a sore arm for a couple of days. Adverse events start date was 23Dec2020 10:00 PM. Treatment included Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of chills was recovered on 24Dec2020, of headache, chills, fatigue and sore arm was recovered in Dec2020, of other events was recovered on 26Dec2020.
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| 43 | 2021-01-05 | nausea |
nausea; Headache; This is a spontaneous report from a non-contactable nurse. A 43-year-old female pa...
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nausea; Headache; This is a spontaneous report from a non-contactable nurse. A 43-year-old female patient received bnt162b2 (BNT162B2 also reported as COVID vaccine (brand Pfizer); lot number: 5730; expiration date: unknown), intramuscular left arm on 19Dec2020 11:00 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that the patient had headache about 2 hours (13:00) after vaccination then about 6 hours (17:00) after she had nausea. The reporter considered the events as non-serious which did not result to death, not life-threatening, or did not caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect. No treatment was received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-01-06 | abdominal pain upper, decreased appetite |
Intense pain at vaccination site, can't use my arm for anything, fever 38.9C that only goes down wit...
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Intense pain at vaccination site, can't use my arm for anything, fever 38.9C that only goes down with ibuprofen. Chills, pain all over the body, can't put my feet on the floor because of plantar pain on my feet. Rib pain and axillary pain on my left side, lack of appetite, throat pain, stomach pain
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| 43 | 2021-01-06 | diarrhea, abdominal pain |
Rash over my back /neck/torso . Fever /body aches /left lower abdominal pain and cramping /diarrhea ...
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Rash over my back /neck/torso . Fever /body aches /left lower abdominal pain and cramping /diarrhea /lower back pain /headache
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| 43 | 2021-01-06 | nausea |
Severe headache that brought tears due to pain. Chills. Nausea. Burp up bile. Exhausted. Subsided a...
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Severe headache that brought tears due to pain. Chills. Nausea. Burp up bile. Exhausted. Subsided after 7 hours. Intermittent headaches that only last for a few minutes and then subside.
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| 43 | 2021-01-07 | abdominal discomfort |
Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two...
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Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration in right arm on 29Dec2020 07:30 at single dose for Covid-19 immunisation. Medical history included rosacea, depression, asthma. The patient was not pregnant. No Covid prior vaccination. No Covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included duloxetine hydrochloride (CYMBALTA), lisdexamfetamine mesilate (VYVANSE), spironolactone and multivitamin. The patient previously took cefalexin (KEFLEX) and experienced allergies: Keflex, rash. The patient developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days on 02Jan2021 09:00 on 02Jan2021 09:00. No treatment received for the events. The events was reported as non-serious. No emergency room/physician office visit. The outcome of events was recovered on 04Jan2021.
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| 43 | 2021-01-07 | nausea, vomiting |
Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "le...
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Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "left eye feels funny, like twitching and my blood pressure feels high" Narrative: Pt reports high anxiety along with stated symptoms.
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| 43 | 2021-01-07 | nausea |
Nausea; malaise; injection site pain; injection site swelling; This is a spontaneous report from a c...
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Nausea; malaise; injection site pain; injection site swelling; This is a spontaneous report from a contactable physician (patient herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) via an unspecified route of administration (arm right), on 04Jan2021 at 15:00, at a single dose, for COVID-19 immunization. Relevant medical history included migraines, seasonal allergies, and history of breast cancer in remission. The patient has no known allergies. Concomitant medication included (FLONASE) fluticasone propionate. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. On 04Jan2021, at 16:45, the patient experienced nausea, malaise, injection site pain, and injection site swelling. The patient did not receive treatment for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
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| 43 | 2021-01-08 | vomiting, diarrhea, nausea |
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills alternating with sweats as well, fever co...
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Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills alternating with sweats as well, fever continued for 2 days, also reporting swollen glands Narrative: Symptoms persisted for 48 hours, with some lingering symptoms beyond 48 hours (headache, aches, swollen glands)
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| 43 | 2021-01-08 | diarrhea, nausea |
Severe chills, headache, stiff neck, nausea, diarrhea, weakness. Onset of chills approx. 8 hours pos...
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Severe chills, headache, stiff neck, nausea, diarrhea, weakness. Onset of chills approx. 8 hours post immunization. Severe shaking chills occurred with decreasing frequency over next 48 hours. Headache more intense for 48 hours, but persists still today (1/9/21). Nausea for 48 hours. Diarrhea lasted 4 days with decreasing frequency. Stiff and painful neck and base of skull has steadily decreased but is still present today (1/9/21).
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| 43 | 2021-01-09 | nausea |
Headache, chills, body ache, severe fatigue, nausea. Symptoms were most severe about 16 hours after...
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Headache, chills, body ache, severe fatigue, nausea. Symptoms were most severe about 16 hours after vaccine
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| 43 | 2021-01-09 | vomiting, nausea |
Immediately after injection, had headache, nausea, vomiting and metallic taste in mouth. Given 50mg...
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Immediately after injection, had headache, nausea, vomiting and metallic taste in mouth. Given 50mg Benadryl with improvement. Nausea/vomiting, metallic taste resolved after 24 hours. Headache and muscle aches lasted 48 hours and improving.
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| 43 | 2021-01-10 | diarrhea | Diarrhea, lasting 15 minutes. Skin rash at site of injection |
| 43 | 2021-01-11 | nausea, vomiting |
C/O neck pain followed by headache , nausea, vomiting, respiratory issues, itching, benedryl 50mg im...
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C/O neck pain followed by headache , nausea, vomiting, respiratory issues, itching, benedryl 50mg im given, VS, med called, started IV, BP 189/102, HR 80 Temp 98.5, 98.1, sent to ED
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| 43 | 2021-01-11 | nausea, vomiting |
Rash Back (L) arm chest pruritic Nausea & vomiting. Swelling (L) arm Exam Rash as above external ves...
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Rash Back (L) arm chest pruritic Nausea & vomiting. Swelling (L) arm Exam Rash as above external vesicle Txt corticosteroid, antihistamines
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| 43 | 2021-01-11 | nausea |
Recieved vaccine on Friday 1/8 in AM, by evening had heaviness in shoulders and headache. 1/9 AM mod...
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Recieved vaccine on Friday 1/8 in AM, by evening had heaviness in shoulders and headache. 1/9 AM moderate fatigue and muscle aches with headache. By 4pm nausea began and temp of 99.4. Severe muscle/joint pain and fatigue progressed from there with temp reaching high of 102.6 before fever broke around 5AM 1/10. Sunday 1/10 - moderate/severe fatigue with low grade temp of 99.6., nausea, headache. Little energy to do anything other than sit on couch. Attempted to go to work Monday 1/11, did have fatigue and headache prior to leaving for work. Once at work developed severe hot/cold flashes on and off with profuse sweating spells anytime I would move around. 1/12 still with headache and nausea.
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| 43 | 2021-01-11 | diarrhea |
Severe diarrhea for 3-4 hours starting 2 hours after vaccine; headache; Fatigue for several day; Thi...
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Severe diarrhea for 3-4 hours starting 2 hours after vaccine; headache; Fatigue for several day; This is a spontaneous report from a contactable other HCP. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 20Dec2020 17:30 at a single dose for covid-19 immunisation. The vaccine was administered in the hospital. Medical history included asthma. The patient was not diagnosed COVID-91 prior to vaccination. There were no concomitant medications. On 20Dec2020 21:00, the patient experienced severe diarrhea for 3-4 hours starting 2 hours after vaccine, fatigue for several days and headache. The outcome of the events was recovered on an unknown date. No treatment was required for the events. The patient was not tested for covid-19 post vaccination. Information about lot/ batch number has been requested.
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| 43 | 2021-01-11 | nausea |
first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, the...
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first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU
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| 43 | 2021-01-12 | abdominal discomfort |
Became dizzy, headache, felt like she was going to faint, rigors and a temperature of 101.5. Next m...
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Became dizzy, headache, felt like she was going to faint, rigors and a temperature of 101.5. Next morning she had upset stomach, feeling dizzy, thought she was going to faint and a headache.
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| 43 | 2021-01-12 | abdominal discomfort | Chills, upset stomach, soreness at injection site, abdominal gas pain |
| 43 | 2021-01-12 | vomiting, nausea | Fever up to 102.9 Chills Nausea and vomiting Earache Headache Backache For |
| 43 | 2021-01-12 | indigestion |
I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received firs...
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I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received first dose on 12/23/2020 and second dose on 1/10/2021. Since vaccine I?ve noticed my reflux has been flared. I haven?t had to take Protonix in months; however, I really started to experience indigestion and chest burning/pressure a week after first dose. I started back taking Protonix and had to increase dose to twice a day on 1/5/2021. Symptoms have improved significantly but it?s still somewhat aggravated. I also experienced lower back pain and upper and lower extremities numbness/tingling maybe 2-3 time since first vaccine
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| 43 | 2021-01-12 | nausea |
Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of ...
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Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Too weak to perform normal activities/slept for 2 days straight; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: El1284 and Expiration Date unknown) via intramuscular route of administration on 05Jan2021 11:00 AM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: Eh9894) via intramuscular route of administration on 17Dec2020 05:00 PM (Left arm) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included known allergy and None other medical history. The concomitant drug was reported as Birth control medication. On 06Jan2021 1:30 am the patient woke up with severe all over muscles pains, with spasms that Tylenol 1000mg did not resolve. The patient had nausea, lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit. The patient slept for 2 days straight, too weak to perform normal activities. The patient continued to have some symptoms 3 days later. No treatment received for the adverse events of nausea, lymphadenopathy, pain in armpit, slept for 2 days straight, too weak to perform normal activities. No COVID prior vaccination and no COVID tested post vaccination. The outcome of event was recovering.
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| 43 | 2021-01-12 | vomiting |
Patient recieved Pfizer vaccine 01/10/21. On 01/11/21 patient started to experience a migraine. On 0...
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Patient recieved Pfizer vaccine 01/10/21. On 01/11/21 patient started to experience a migraine. On 01/12/21 patient started to expereince a worsened mirgraine accompanied with vomiting and severe back pain.
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| 43 | 2021-01-12 | nausea |
Red raised circle with severe swelling in the upper arm, chills in the morning, whole body muscle pa...
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Red raised circle with severe swelling in the upper arm, chills in the morning, whole body muscle pain, and nausea starting Thursday afternoon. Started a fever of 100 f and a headache Thursday night. The headache, nausea, and swelling in the arm lasted until Sunday night.
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| 43 | 2021-01-13 | nausea |
8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs 54...
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8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs 54hrs post vaccine-Pounding Migraine that lasted 24hrs Pain at injection arm 24 hrs post vaccine.
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| 43 | 2021-01-13 | difficulty swallowing, vomiting |
Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, prog...
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Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report
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| 43 | 2021-01-13 | nausea | Body aches, fever, headache, nausea |
| 43 | 2021-01-13 | decreased appetite, nausea |
Pain at the injection site. That night and next day I felt fatigue and slept most of the day. I had...
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Pain at the injection site. That night and next day I felt fatigue and slept most of the day. I had no appetite and had nausea that would come and go. Decreased exercise for a couple days after. The following Monday I still had some fatigue but felt tired and low level nausea and not really hungry, There were waves when I felt like I was coming down with something. I felt tired enough that I went home early from a shift and tested for Covid. Test came back negative.
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| 43 | 2021-01-14 | nausea |
5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of ...
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5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of breath tachycardia, nausea. Taken to ER and given IM Epi, IV Benadryl, Solumedrol, Pepsi?s, albuterol and racemic epi breathing treatments and put on Epinephrine IV drip to treat anaphylactic reaction
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| 43 | 2021-01-14 | nausea, decreased appetite | FEVER, BODY ACHES, NAUSEA, LOW APPETITE, WEAKNESS (FLU-LIKE SYMPTOMS) FOR 24 HOURS |
| 43 | 2021-01-14 | nausea, vomiting |
Patient was nauseous, threw up slightly and had a headache. This lasted for about 30 minutes, which...
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Patient was nauseous, threw up slightly and had a headache. This lasted for about 30 minutes, which occurred about 15 minutes after the vaccine administration. She also had a headache that persisted through till the next day,
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| 43 | 2021-01-14 | nausea, abdominal pain |
Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning...
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Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
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| 43 | 2021-01-14 | abdominal pain, nausea |
Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning...
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Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
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| 43 | 2021-01-15 | decreased appetite |
Severe muscle and joint pain, fatigue, low grade fever for 2 days. Loss of appetite. Treatment Tyle...
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Severe muscle and joint pain, fatigue, low grade fever for 2 days. Loss of appetite. Treatment Tylenol 650 mg and Ibuprofen 400 mg. Symptoms resolver after 2 days
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| 43 | 2021-01-17 | abdominal pain |
Covid vaccine #1 3 days ago. Last night she started having chills diaphoresis broke out in sweats an...
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Covid vaccine #1 3 days ago. Last night she started having chills diaphoresis broke out in sweats and having abdominal pain
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| 43 | 2021-01-17 | nausea, retching, abdominal discomfort |
Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred per...
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Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred peripheral vision in left eye only. Dizziness, wooziness. All resolved with 35 minutes of injection, initially. Within 4 hours of shot-Exponential increase in pain from waist down, including lower back pain. Took Motrin 600 mgs which resolved pain within 1 hour of taking it. Felt off/not myself-Felt foggy-headed-pressure in head and ears was not normal. 2100-0000 (Evening of shot)-Moderate sporadic dizziness that became moderate constant dizziness-Took 1 25 mg chewable Meclizine with 1 cup of water. Pain increased and Motrin wore off. Fatigue grew worse. 1/13/21-1/14/21-SEVERE back pain. Intense pain in legs and hips. Upper respiratory symptoms-Nasal congestion, ear pressure, sinus pain/pressure, chest and upper back discomfort, chest congestion, irritation, and aching. Cheeks and nose looked puffy/swollen. Eye pain, headache on and off. Fatigue, dragging. Felt feverish but no actual fever. Body aches-sides, legs-front, back, and sides, lower back, and glutes. Felt like arthritis from waist down, including lower back. Took nighttime cold syrup, etc. to be able to sleep and/or at least dull the pain. Also used heating massage pad to assist with pain relief. 1/15/21-1/16/21-Pain lessened in terms of intensity. Had longer spells of less intense pain. Also less pain with movement after resting/lying down. However, pain still intense at this point. Meds more helpful with the pain at this point as well. On Sat, felt dizzy and unwell all day, including extra tired. Hot, sweaty on Sat. Racing heart, chest tightness. Used inhaler and Metoprolol. 1/17/21-Felt unwell-intense pain still, dizziness, fatigue. Took Meclizine 25 mg that morning. Also took another 25 mg Meclizine later that afternoon. Nausea, dry heaving to the point I almost vomited 2x. After napping, nausea returned slightly but immediately went away. Felt very tired remainder of the evening. 1/18/21-Went to MD to get clearance to return to work. Dizziness prior to visit and took 1/2 25 mg Meclizine. Felt better until I got to doctor's office. While waiting to be called back, dizziness started up again and got severe. While waiting on MD to come in and talk to me, I got nauseated and felt like I might dry heave/vomit. I took another 1/2 Meclizine 25 mg and sucked on a mentholated cough drop to help with nausea, which did subside. Dizziness continued to be severe. MD took blood pressure, pulse ox, checked my ears, checked my pupils, listened to me breathe, asked me about my symptoms, return to work, and advised on safety of taking 2nd COVID injection when it is time but leaving it up to me in terms of if I feel benefits outweigh possible side effects of 2nd injection. He prescribed anti-nausea meds, pain meds, and stated he wants to see me for a follow-up visit in 1 week. He also prescribed steroid and pain med injections to be administered in office immediately, steroid injection sometimes contains Benadryl and based on how I felt after the shot, there may have been Benadryl in this one. He also requested I message him later in the day to let him know how I was feeling. Injections did GREATLY assist with pain and dizziness/foggy-headed feeling, once they kicked in. I did message him letting him know how I was feeling after napping. 1/18/21 evening-I am still feeling weak and tired and having stinging like pain in both legs along with minor lower back pain. Some chest and throat irritation as well as stomach discomfort. Going to take a gentle laxative as well as some of the nighttime cold medicine I purchased. Still also having dizziness on and off. I plan to return to work tentatively, on 1/19/21, per my return to work note from MD. I will keep my MD notified of how I feel between now and next Monday's follow-up.
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| 43 | 2021-01-17 | nausea |
about 12 hour after injection chills, fever, bone pain, joint pain, muscle aches, headache, sore thr...
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about 12 hour after injection chills, fever, bone pain, joint pain, muscle aches, headache, sore throat, nausea. Symptoms lasted about 36 to 48 hours with lingering muscle aches and headache
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| 43 | 2021-01-18 | diarrhea | Diarrhea |
| 43 | 2021-01-18 | vomiting |
Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy...
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Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.
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| 43 | 2021-01-18 | abdominal pain upper |
intermittent fevers, extreme muscle ache, Left axillary lymphadenopathy for over 24 hours. Took ibup...
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intermittent fevers, extreme muscle ache, Left axillary lymphadenopathy for over 24 hours. Took ibuprofen and tylenol which exacerbated stomach ache. Then took sucralfate and esomeprazole and tylenol supp.
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| 43 | 2021-01-18 | vomiting |
received injection before noon, by 1800 reported mild chills. After midnight, chills became worse, ...
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received injection before noon, by 1800 reported mild chills. After midnight, chills became worse, temp=101.6. Severe chills 0400, diaphoresis. 0900 body aches, especially back and legs. swollen axillary lymph node on arm of injection. Began vomiting intermittently until 1630. two days post injection awoke fully recovered with exception of tender, swollen axillary lymph node on arm of injection.
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| 43 | 2021-01-19 | abdominal pain, abdominal pain upper | Abdominal pain, epigastric and periumbilical. Worse over 24 hrs. Took over 48 hrs to resolve |
| 43 | 2021-01-19 | nausea, vomiting |
About 24hrs later on the 12/24/2020 I started getting a headache it lasted until 12/30/2020. But on ...
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About 24hrs later on the 12/24/2020 I started getting a headache it lasted until 12/30/2020. But on 12/27/2020 I stated feeling nauseas & I was vomiting. On 12/30/2020 I had to see a doctor.
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| 43 | 2021-01-19 | diarrhea, abdominal discomfort |
Arm pain that lasted for approximately one day-no treatment needed Low grade fever that lasted less ...
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Arm pain that lasted for approximately one day-no treatment needed Low grade fever that lasted less than 12 hours-no treatment needed Mild body aches that lasted less than 12 hours-no treatment needed Gastrointestinal upset/diarrhea that lasted less than 12 hours-no treatment needed
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| 43 | 2021-01-19 | nausea |
Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopa...
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Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopathy and nausea- started 48 hrs after injection
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| 43 | 2021-01-19 | diarrhea |
During the night had uncontrollable chills, diarrhea, fever that started at 99.6 and jumped to 102.4...
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During the night had uncontrollable chills, diarrhea, fever that started at 99.6 and jumped to 102.4. Muscle aches mostly to lower back. Felt like back was crushing
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| 43 | 2021-01-19 | abdominal pain upper, diarrhea | Headache, stomach ache, diarrhea |
| 43 | 2021-01-19 | vomiting |
Patient called to report a severe reaction today, 1/20/21. She stated approximately 12 hours after s...
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Patient called to report a severe reaction today, 1/20/21. She stated approximately 12 hours after she received the vaccine, she began having severe chills and muscle aches with fever up to 102.6 that did not respond to Tylenol. Also had headache, vomiting, fatigue, shortness of breath, and chest tightness. After approximately 12-18 hours, her symptoms started improving, but still having mild to moderate muscle aches, fatigue, and shortness of breath. Using albuterol prn. Currently recovering at home.
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| 43 | 2021-01-19 | difficulty swallowing |
Patient received 2nd dose Pfizer @ 1549, after 10 minutes of monitoring patient c/o of tightness & f...
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Patient received 2nd dose Pfizer @ 1549, after 10 minutes of monitoring patient c/o of tightness & felt "slow swelling" in her throat. Also reporting "slow swallowing sensation" Patient brought out to back triage area, vitals stable, NO SOB, no wheezing, no lip or tongue swelling noted. 167/95, 63, 99% RA. Reporting feeling anxious. Only allergy or similar event patient reports is medication, ephedrine during delivery which was treated w/ O2 during her delivery Repeat vitals 134/90, 59, 99% Allergy MD on call notified of event, per MD continue to monitor for additional 30 minutes and call back w/ any further symptoms 136/93, 60 & 99% After 30 minutes, patients vitals stable, sensation has resolved & felt well enough to go home 127/92, 59 & 99%
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| 43 | 2021-01-19 | nausea |
Soreness in left upper arm and neck. The next day also had a 100.2 temperature with fatigue and naus...
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Soreness in left upper arm and neck. The next day also had a 100.2 temperature with fatigue and nausea.
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| 43 | 2021-01-19 | vomiting |
approximately 12 hours after vaccine was administered, patient experienced the following symptoms: s...
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approximately 12 hours after vaccine was administered, patient experienced the following symptoms: severe chills and muscle aches; fever of 102.6 that did not respond to Tylenol, headache, vomiting, fatigue, shortness of breath, and chest tightness. She states they lasted for approximately 18 hours, and have started improving in the past 24 hours. Still having symptoms of mild to moderate muscle aches and some shortness of breath. Using albuterol inhaler as needed. Patient is recovering at home currently.
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| 43 | 2021-01-19 | nausea |
myalgias; severe headache; rigors; low-grade fever; nausea; fatigue; This is a spontaneous report fr...
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myalgias; severe headache; rigors; low-grade fever; nausea; fatigue; This is a spontaneous report from a contactable Physician (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscularly in right arm on 06Jan2021 11:30 at single dose for COVID-19 immunization. Facility type Vaccine: Hospital. Medical history included acne. Known allergies: No. Other medical history: none (on aldactone for acne). The patient was not pregnant. Concomitant medication in two weeks included spironolactone (ALDACTONE) for acne. The patient previously received the first dose of BNT162B2 (lot number EH9899) intramuscularly in right arm on 16Dec2020 11:30 for COVID-19 immunization. If other vaccine in four weeks: No. The patient experienced myalgias, severe headache, rigors, low-grade fever, nausea, fatigue 06Jan2021 15:00. The patient received treatment Ibuprofen and Acetominophen for the events. If Covid prior vaccination: No. If covid tested post vaccination: No. The outcome of all the events was recovered in Jan2021. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
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| 43 | 2021-01-20 | nausea |
Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post ...
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Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; This is a spontaneous report from a contactable physician (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1283), via an unspecified route of administration on 09Jan2021 06:30 at a single dose on right arm for COVID-19 immunization. Medical history included depression, obesity, penicillin and bee sting allergies. The patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID prior to vaccination. Concomitant medications included venlafaxine, cetirizine and ibuprofen. The patient previously took ceftriaxone sodium (ROCEPHIN) and experienced allergies. The patient was given first dose of bnt162b2 on 19Dec2020 18:30 on left arm for COVID-19 immunization (lot number: Eh9899). No other vaccines in four weeks prior to COVID vaccine. On 09Jan2021 18:00, the patient experienced malaise, myalgias, arthralgias, headache, fever and nausea from 12 hours post injection until 36 hours post injection. Treatment was given for the adverse events which included acetaminophen and ibuprofen. The patient has not been tested for COVID post vaccination. The patient was recovering from the events.
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| 43 | 2021-01-21 | diarrhea | 7 days after shot lots of gas and diarrhea and 8-9 days |
| 43 | 2021-01-21 | nausea |
About 40 mins after the injection, I was beyond extremely tired. Extreme body aches, nausea, dizzine...
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About 40 mins after the injection, I was beyond extremely tired. Extreme body aches, nausea, dizziness and migraine followed shortly after. I felt to have more of an agitated PVC, PAC and tachycardia activity than usual. This lasted Friday 1/8 through all day Sunday 1/10. On 1/11 I only suffered from the migraine. A very sore arm was only during the first night and alleviated on Saturday afternoon.
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| 43 | 2021-01-21 | nausea |
Dizziness, lightheadedness, sweating, blurry vision, nausea immediately following injection. Later t...
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Dizziness, lightheadedness, sweating, blurry vision, nausea immediately following injection. Later that day/evening patient developed rheumatoid arthritis flair up that resolved over the course of two days and use of prescription medications (diphenhydramine and prednisone). Patient has a long standing history of rheumatoid arthritis.
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| 43 | 2021-01-21 | vomiting, diarrhea, nausea |
First 24 hours-body aches and headache, resolved at 48 hours. 48-72 hours felt fine. 72 hours -onset...
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First 24 hours-body aches and headache, resolved at 48 hours. 48-72 hours felt fine. 72 hours -onset of nausea and severe headache, quickly shifted into diarrhea and two rounds of heavy vomiting (patient rarely vomits even when sick)
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| 43 | 2021-01-21 | diarrhea |
I started with under arm- armpit pain last night and this morning noticed that my glands and or lymp...
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I started with under arm- armpit pain last night and this morning noticed that my glands and or lymph nodes under the left arm are very swollen- knots. It alarmed me. I have also had diarrhea since the day of vaccine and just feel over all flushed and very sleepy/tired.
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| 43 | 2021-01-21 | nausea |
Received her second dose of vaccine on 1/12/21 and 2.5 hours later felt shaky, dizzy, nauseated, pal...
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Received her second dose of vaccine on 1/12/21 and 2.5 hours later felt shaky, dizzy, nauseated, pale and diaphoretic. Seen in the ED and was given fluids and monitored a couple hours and released. On 1/21/20 she continued to feel poorly with dizziness and ringing in her ears. She was seen by her physician and given a steroid injection and a meclizine prescription. Physician believes her symptoms are a continued reaction to the vaccine.
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| 43 | 2021-01-22 | vomiting, diarrhea, nausea |
Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, m...
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Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, midday body aches, chills, finger swelling and joint swelling ha, fvr low grade. I took ibuprophen. By evening add nausea, vomitting, near syncopal event (had to sit quickly b4 passing out), heart palpitations, light headed, chest pressure and just off feeling, fatigue. By 1/9 all same symptoms, 2 more near -syncopal events, rt knee pain, and asthma (I used inhaler x 3 times). Then 1/10 upon waking, I felt amazing and 100% better. During first 3days of symptoms, I slept alot.
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| 43 | 2021-01-24 | vomiting |
I received an instant headache, my left arm swelled and was painful from my shoulder down to my hand...
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I received an instant headache, my left arm swelled and was painful from my shoulder down to my hand. Later in the day i became extremely tired, had pain in my neck. The next day i was still very tired, arm pain, headache, body aches, vomiting. Day 4 i am still very tired with body aches.
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| 43 | 2021-01-24 | nausea | Nausea, Headache, Fever, Chills |
| 43 | 2021-01-24 | nausea |
Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hemato...
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Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hematocrit were slightly low; fluttering in chest; Rash on left side of face and neck; skin started burning; Anxiety and fear; Anxiety and fear; Racing heart beat; Dizziness/Lightheadedness; Headache; Nausea; Has been on her period for three weeks/Is premenopausal/Was bleeding at time of vaccination; This is a spontaneous report from a contactable Nurse reporting for herself. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at right arm on 06Jan2021 15:22 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, No agency site. Medical history reported included breast implants, She was healthy and had no medical diagnoses. The patient's concomitant medications was reported as none, She took no medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wanted to report a possible reaction to the COVID Vaccine. Has been to the ER three times. Had a racing heart beat, dizziness, lightheadedness, and nausea on 08Jan2021. Developed a rash and skin started burning on 11Jan2021. The rash was on the left side of her face and neck. Racing heart beat started first. Then dizziness, headache, lightheadedness, and nausea began. She also had anxiety and fear. All symptoms began on 08Jan2021. Went to the ER on 08Jan2021. Was discharged from the Emergency room. Last night, 11Jan2021, she felt fluttering in chest, but it wasn't as severe as two nights ago. Her EKG was normal. Patient Hoped nothing occurs today. Took three Benadryl last night. Racing heart beat, rash, dizziness, headache, lightheadedness, nausea were all ongoing. The patient was wearing a Halter monitor until 12Jan2021 at 15:00, total duration for Halter monitor is 24 hours. Seriousness: Definitely disabling. Sunday night she thought she might not wake up Monday. She was fearful of all of the weird. Investigations: The patient was advised her labs were ok. Red blood cells are a little low. Hemoglobin and hematocrit were slightly low. Thought hemoglobin was 10.7. EKG was normal, Chest X-Ray was negative. The patient was just trying to figure out why reaction occurred. She Had been on her period for three weeks, was pre-menopausal. Was bleeding at time of vaccination on 06Jan2021. She did have breast implants, and didn't know if that was related or not. The patient Would not be getting the second injection. The nurse assessed the events of Racing heart beat, Anxiety and fear and Rash on left side of face and neck as related. The outcome of the event fluttering in chest was recovering, the outcome of the events Racing heart beat, rash, dizziness/ lightheadedness, headache, and nausea was not recovered and the outcome of the other events was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac flutter, palpitations, headache, dizziness and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-01-24 | nausea |
Sore arm noted day of vaccine. Following day noted fatigue, dizziness, nausea, chills, body aches, ...
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Sore arm noted day of vaccine. Following day noted fatigue, dizziness, nausea, chills, body aches, headache. Most symptoms subsided the next day, headaches and dizziness continue daily one week later.
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| 43 | 2021-01-25 | nausea | Fever 102.3 Joint pain Chills Nausea |
| 43 | 2021-01-26 | nausea |
Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick...
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Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick. within 30 minutes of then end escalating over the next hour, I had a severe headache, bilateral, occipital, pressure in entire head and neck. The headache as also in my eyes and in my ears. Back was also painful - not as bad as neck, but i can't explain how horribly a hope a massage could fix me. There was no comfortable position to alleviate any of that. I also got the chills, constantly, suddenly switching from shivering cold to so hot i needed to take blankets off - but soon as i took the blankets off I'd be freezing cold again. I was also super nauseous, though i didn't vomit. I pretty much couldn't get out of bed much for 24-36 hours. During that time, i was unable to sleep as well, i think mostly due to the chills, constantly having to move about to keep warm or cool off, but not sure. I did take acetaminophen around 10pm 1/26 (36 hours after injection)- i felt like I knew you're not supposed to, but I couldn't take it any more and it might have less anti-inflammatory impact than ibuprofen. It dulled the pains some, but didn't make it stop. the chills and nausea mostly stopped and was able to sleep more the second night, last night. I'm now up and trying to work today (1/27). Head still has pressure headache throughout. Neck is still sore, like a pressure headache. I feel generally foggy and heavy.
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| 43 | 2021-01-26 | diarrhea | Fatigue, chills, high fever(101.4), body aches, diarrhea, headache-lasted 24 hours and still going |
| 43 | 2021-01-26 | nausea |
Reaction to second COVID vaccine fever of 100.8 chills body aches joint pain nausea HA lasted over 2...
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Reaction to second COVID vaccine fever of 100.8 chills body aches joint pain nausea HA lasted over 24 hours
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| 43 | 2021-01-26 | vomiting, nausea |
Woke up the first night with body aches and fever. The next day felt nauseous with vomiting and bod...
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Woke up the first night with body aches and fever. The next day felt nauseous with vomiting and body aches. Day 3 still had some body aches. Day 4 the pt returned to feeling normal.
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| 43 | 2021-01-26 | diarrhea, nausea |
extreme headache; muscle aches; chills; nausea; diarrhea; sweating; tachycardia; This is a spontaneo...
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extreme headache; muscle aches; chills; nausea; diarrhea; sweating; tachycardia; This is a spontaneous report from a contactable nurse. This 43-year-old female nurse (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular at left arm on 11Jan2021 06:15 PM at single dose for COVID-19 immunization. Patient was not pregnant. Medical history included anxiety, migraines, palpitations and known allergies: latex, adhesive. Concomitant drugs included paroxetine hydrochloride (PAXIL), alprazolam (XANAX), and unspecified multivitamin. Historical vaccine included the first dose of BNT162B2 on 21Dec2020 06:15 PM via intramuscular at left arm for COVID-19 immunization, and patient had headache and nasal congestion. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Jan2021 09:45 PM, patient experienced extreme headache, muscle aches, chills, nausea, diarrhea, sweating, tachycardia. No treatment was received. Outcome of events was unknown. Information on the lot/batch number has been requested.
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| 43 | 2021-01-27 | appendicitis | 4 days after receiving dose, developed a cute appendicitis. Appendectomy performed. |
| 43 | 2021-01-27 | nausea, vomiting |
Fever of 101.7 F resolving 01/28/2021 around 3pm. Muscle aches, malaise. Better on 01/28/21 Nausea ...
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Fever of 101.7 F resolving 01/28/2021 around 3pm. Muscle aches, malaise. Better on 01/28/21 Nausea and vomiting started on 01/2721, required IV fluids on 01/28/2021 at approximately 4:30am. Feeling better this afternoon 01/28/2021.
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| 43 | 2021-01-27 | nausea |
PT developed ST and fever 102.7, nausea and body aches yesterday; she got a second COVID vaccine, Pf...
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PT developed ST and fever 102.7, nausea and body aches yesterday; she got a second COVID vaccine, Pfizer, 2 days ago, she feels better today, able to eat and drink, but needs tests for work.
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| 43 | 2021-01-27 | nausea |
Vertigo/dizzy/room spins starting; dizzy/room spins starting; Fatigue; Sore body; HA (headache); Nau...
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Vertigo/dizzy/room spins starting; dizzy/room spins starting; Fatigue; Sore body; HA (headache); Nausea; Racing thoughts; trouble sleeping; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 10Jan2021 14:45 at single dose for COVID-19 immunization. Medical history included seasonal allergies, anxiety, depression, high cholesterol, tinnitus and GERD; all from an unknown date and unknown if ongoing. Concomitant medication included valaciclovir hydrochloride (VALTREX), omeprazole magnesium (PRILOSEC), iron, atorvastatin (LIPITOR), melatonin and BCP. The patient was previously vaccinated with first dose of BNT162B2 via unspecified route in left arm on 20Dec2020 15:00 for COVID-19 immunization and experienced vertigo/dizzy/room spins starting on 08Jan2021 23:30. The patient was not pregnant. The experienced vertigo/dizzy/room spins starting 1-2 days prior to 2nd vaccine 10Jan2021 then it was worsened in Jan2021 after 2nd vaccine. The patient experienced fatigue, sore body, HA (headache), nausea, racing thoughts and trouble sleeping in Jan2021. No treatment was given to the patient for the events. The outcome of the events was not recovered. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 43 | 2021-01-28 | difficulty swallowing |
1:15 PM: pt received vaccination. 1:18 PM: pt states her throat feels "thick" and "uncomfortable to ...
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1:15 PM: pt received vaccination. 1:18 PM: pt states her throat feels "thick" and "uncomfortable to swallow". Oxygen saturation: 100% and HR: 85. 1:30 PM: Oxygen saturation : 98%, HR: 69 1:35 PM: Oxygen saturation: 98%, HR: 70. Reports feeling better. Sensation is improving. 1:40 PM: Oxygen saturation: 99%, HR 65, pt reports she feels okay 1:45 PM: Oxygen saturation: 98%, HR 67. 1:50 PM: Oxygen saturation: 98%, HR 70. Pt states she is ready to go and is feeling better. She had no difficulty talking or breathing.
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| 43 | 2021-01-28 | abdominal discomfort, diarrhea |
Arm pain , arm feels heavy and very painful. Lots of stomach growling, and some stomach discomfort,...
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Arm pain , arm feels heavy and very painful. Lots of stomach growling, and some stomach discomfort, gases and diarrhea,
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| 43 | 2021-01-28 | nausea, abdominal pain |
Bad headache (migraine like, right sided) Abdominal pain Nausea Fever 100.4 Myalgias Arthralgia Pr...
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Bad headache (migraine like, right sided) Abdominal pain Nausea Fever 100.4 Myalgias Arthralgia Profound fatigue/weakness
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| 43 | 2021-01-30 | decreased appetite |
Around 8:00am, I started to feel tired and weak. Through the course of the day, I ran a fever of 102...
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Around 8:00am, I started to feel tired and weak. Through the course of the day, I ran a fever of 102.4. I had chills, a headache, very sore injection site, and the skin on my arms hurt. I was exhausted, but couldn't sleep. I took Tylenol, but it didn't seem to help much. I didn't have much of an appetite. Around 7:00pm, I no longer had chills but instead was very hot. About 2:00am, I woke up drenched in sweat, but felt so much better.
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| 43 | 2021-01-31 | abdominal discomfort, abdominal pain upper |
01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout t...
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01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout the day. 01/30/2021 very tired (to be expected), noticed I had burning in what feels like my gall bladder and developed an ?odd? stomach ache later in the day. Thought it had to do with something I ate, but consumed nothing out of the ordinary. Went to bed early, felt like I wanted to fever but never did. decided to take a tsp of children?s Allegra because I still felt ? itchy? at times. 01/31/2021 woke up to what felt like pressure on my chest, like someone was squeezing me. Thought that was odd and thought it was perhaps the way I slept. Was still tired (4AM) went back to sleep. Woke up again feeling more rested and the same feeling. It was an awful feeling. Grabbed my pulse oximeter and my oxygen was about 96 laying down. Called an. ER, thought maybe I had Covid or something as I have never felt that way before. Receptionist told me she felt the same way after she got the shot. I ate, felt better but then developed a horrific headache akin to a migraine that was so sensitive to any movement I made. Felt like someone was shaking my head, it was so painful and I became disoriented. Like. I would get confused in my thoughts. Became very sensitive to light and movement. Looking at Facebook, I had to stop because I felt like I was going to seizure. Had to really rest. Ate lunch and took a multivitamin to see if that helped. Eventually I felt better but had to be careful, take it easy. 02/01/2021 woke up this morning still tired, like my body is fighting something. And I could fell the headache coming on and noticed I was getting confused in my thoughts. I decided to stay home from work. The morning was very bad as I felt as though I wanted to seizure. Could not get a hold of my doctor. My head still hurts, not as bad, but after I eat, I get confused and can?t hold two thoughts at once if that makes sense. Head seems very sensitive to eye movement like yesterday. It?s a gross feeling, even in absence of the pain.
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| 43 | 2021-01-31 | nausea |
A couple of days later after the vaccine, I started with a runny nose, sneezing, nausea, itchy throa...
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A couple of days later after the vaccine, I started with a runny nose, sneezing, nausea, itchy throat, painful cough, chills. No fever. On 01/01 I woke up and had no voice. I went straight to the UC and they diagnosed me with upper respiratory infection, I was treated with azithromycin and something else for nausea. About days later I was totally fine.
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| 43 | 2021-01-31 | diarrhea |
Fatigue; headache; constipation; then extremely loose stools and 1 event of loss of bowel control.; ...
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Fatigue; headache; constipation; then extremely loose stools and 1 event of loss of bowel control.; then extremely loose stools and 1 event of loss of bowel control.; This is a spontaneous report from a contactable Other healthcare professional (patient). A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249), via an unspecified route of administration on 13Jan2021 16:00 at single dose in Left Arm for COVID-19 immunization. The patient medical history was not reported. There were no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). There were no other vaccines received in four weeks. The patient did not have COVID-19 prior vaccination and COVID-19 was not tested post vaccination. The patient experienced Fatigue, headache, constipation, then extremely loose stools and 1 event of loss of bowel control on 13Jan2021 17:00, no treatment received for these events. The outcome of the events was unknown.
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| 43 | 2021-02-01 | vomiting, abdominal pain upper, diarrhea, nausea |
severe diarrhea; stomach cramping; vomiting; nausea; fatigue; headaches; This is a spontaneous repor...
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severe diarrhea; stomach cramping; vomiting; nausea; fatigue; headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142) on 12Jan2021 at 12:00 pm at single dose via an unspecified route of administration on arm left for COVID-19 immunization. Relevant medical history included high blood pressure and celiac disease. Concomitant medications included unspecified high blood pressure medicine. On 12Jan2021 at 20:00 patient experienced severe diarrhea, stomach cramping, nausea, vomiting, fatigue and headaches. This lasted 10 days so far (as reported). The events were reported as non serious. Treatment received includes Antacid, anti-nausea medication and immodiome. At the time of the reporting the patient had not yet recovered from the events.
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| 43 | 2021-02-02 | abdominal pain, nausea |
Anaphylaxis refractory to IM episode x3, steroids, H1 blocker requiring incubation. Specifically res...
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Anaphylaxis refractory to IM episode x3, steroids, H1 blocker requiring incubation. Specifically respiratory distress with stridor, nausea, and generalized abdominal pain.
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| 43 | 2021-02-03 | nausea, diarrhea |
Headache; diarrhea; nausea; lethargy; This is a spontaneous report from a contactable other healthca...
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Headache; diarrhea; nausea; lethargy; This is a spontaneous report from a contactable other healthcare professional (hcp reported for self). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot EK9231, expiry date not reported), via an unspecified route of administration on 16Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included known allergies to poultry and egg. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications included ethinylestradiol, norethisterone (CYCLAFEM 0.5/35), riboflavin (VIT B2), colecalciferol (D3), magnesium, and bifidobacterium lactis (PROBIOTIC); all reported as other medications in two weeks. Patient had no other vaccine in four weeks. On an unspecified date in Jan2021 (also reported as 03Jan2021; pending clarification), the patient experienced headache, diarrhea, nausea, and lethargy continued after 4 days. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The events headache, diarrhea, nausea, and lethargy were not recovered.
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| 43 | 2021-02-03 | nausea |
Very dizzy, light headed, did not feel good felt unbalance like a motion sickness , headaches, ringi...
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Very dizzy, light headed, did not feel good felt unbalance like a motion sickness , headaches, ringing in ear, and nausea. Blood pressure was elevated.
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| 43 | 2021-02-04 | nausea | Chills, headache, nausea, severe myalgias and arthralgias |
| 43 | 2021-02-04 | abdominal pain |
I was approximately 4 weeks pregnant at the time that I received dose #1 (12/23/20)- I was unaware o...
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I was approximately 4 weeks pregnant at the time that I received dose #1 (12/23/20)- I was unaware of the pregnancy. I was diagnosed with COVID on 12/28/20, but was first symptomatic on 12/24. I attributed my s/s initially to the vaccine. I was eventually tested on 12/28/20, as my symptoms worsened and I was positive for COVID. On 1/14/21 I received my second dose, my COVID s/s had been resolved since 1/4/21. On the evening of 1/18/21 I started experiencing mild abdominal pain. This progressed, on the evening 1/20 the pain was no longer tolerable. I went to the ER where I hemorrhaged and needed emergency surgery and a blood transfusion for a miscarriage. The surgery ultimately took place in the early morning hours of 1/22/21, followed by the blood transfusion.
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| 43 | 2021-02-04 | nausea |
Prolonged fatigue, nausea, low grade fever, lightheadedness 4 days after 2nd dose and still present ...
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Prolonged fatigue, nausea, low grade fever, lightheadedness 4 days after 2nd dose and still present 14 days after vaccine dose
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| 43 | 2021-02-05 | nausea, vomiting |
Received dose #2. Within 10 minutes, developed metallic taste. 4 hours later severe nausea and vomit...
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Received dose #2. Within 10 minutes, developed metallic taste. 4 hours later severe nausea and vomiting. Began alternating Tylenol and Ibuprofen 800mg. 6 hours to the following day- severe headaches, chills, body aches, all over joint pain. Around midnight on 1/6/21 pain in the arm that radiated up her neck. 1/7- fever of 101. Small rash around injection site and slightly down arm. Stiff neck and arm pain.
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| 43 | 2021-02-07 | diarrhea, nausea |
Headache; Nausea; extreme Diarrhea; This is a spontaneous report from a contactable consumer (patien...
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Headache; Nausea; extreme Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249), via an unspecified route of administration at the left arm on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient medical history includes chronic kidney disease. The patient was not pregnant from the time of administration. The patient was taking numerous unspecified medications. The patient previously took amoxicillin sodium;clavulanate potassium (AUGMENTIN) and experienced allergy. On 21Jan2021 at 04:30 PM the patient experienced headache, nausea and extreme diarrhea. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The vaccine was administered in doctor's office/urgent care. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.
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| 43 | 2021-02-08 | diarrhea, nausea | Diarrhea, fatigue, nausea, chills, low grade fever - began 2/9/2021 |
| 43 | 2021-02-09 | abdominal pain, abdominal discomfort, vomiting, nausea |
Arm was extremely sore; Felt very fatigued and achy; Felt very fatigued and achy; Stomach is still u...
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Arm was extremely sore; Felt very fatigued and achy; Felt very fatigued and achy; Stomach is still upset; Haven't felt like doing anything; Nausea; Abdominal pain; Threw up twice; This is a spontaneous report from a contactable healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscularly on the right arm on 20Jan2021 (16:00) at a single dose for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC), spironolactone, fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC) and desogestrel, ethinylestradiol (MIRCETTE). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 30Dec2020 (when the patient was 43 years old) on the left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On the day of the vaccination, the patient was fine. The following day, 21Jan2021 (16:30), the patient's arm was extremely sore; she had felt very fatigued and achy; stomach was upset; and had not felt like doing anything. On 21Jan2021, at night, the patient had nausea, abdominal pain, and had threw up twice. The patient did not receive any treatment for the events. The outcome of the events, 'arm was extremely sore', 'felt very fatigued and achy', 'stomach was upset', 'had not felt like doing anything', 'nausea', 'abdominal pain' and 'threw up', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination. Information on the lot/batch number has been requested.
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| 43 | 2021-02-09 | vomiting, diarrhea |
Patient got her 2nd covid shot on Thursday am. Felt fine Friday other then possibly a little achy an...
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Patient got her 2nd covid shot on Thursday am. Felt fine Friday other then possibly a little achy and totally fine Saturday. Felt somewhat fatigued Sunday afternoon. Woke early Monday am around 1am with sudden vomiting and diarrhea. Noted multiple loose stools and multiple episodes of vomiting and unable to tolerate eating or drinking. Also noted feeling cold. Noted feeling dizzy and lightheaded. Continues to feel achy. Came into Urgent care for fluids on Monday 2/8 and Tuesday 2/9.
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| 43 | 2021-02-16 | difficulty swallowing |
pt presented with erythema & swelling of face & periorbital regions C/O feeling fullness in tongu...
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pt presented with erythema & swelling of face & periorbital regions C/O feeling fullness in tongue & throat & some difficulty swallowing approx 30 - 45 min following vaccine Had also eaten a english muffin with plain cream cheese just prior to symptom onset She was noted to have mild swelling of her tongue & very sl lower lip She was administered 50 mg of diphenhydramine, 20 mg famotidine & 60 mg Prednisone & cold compress to face Was able to take all orally with water & had no difficulty -- after approx 30 minutes her s/s had much improved & her facial erythema & swelling had reduced no resp distress and O2 sat was 99%
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| 43 | 2021-02-21 | nausea | Parosmia foul smelling odors no one else smells that makes me very nauseous |
| 43 | 2021-02-22 | diarrhea | Tightness in left arm immediately; dizziness - 2 hrs later; significant diarrhea from 8pm - 4am. |
| 43 | 2021-02-23 | nausea, diarrhea |
Bone, joint, muscle aches. Headache. Weakness. 2/20/21 to 2/21/21 Swollen lymph nodes under arm and ...
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Bone, joint, muscle aches. Headache. Weakness. 2/20/21 to 2/21/21 Swollen lymph nodes under arm and into breast, bruising and tenderness. 2/20/21 to current Nausea and diarrhea 2/20/21 to current Exhaustion 2/20/21 to current
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| 43 | 2021-02-23 | nausea |
Injection site bruising and pain; Injection site bruising and pain; Nausea; This is a spontaneous re...
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Injection site bruising and pain; Injection site bruising and pain; Nausea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), via an unspecified route of administration on 15Jan2021 08:00 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient was not pregnant. The patient experienced nausea, injection site bruising and pain at 15Jan2021 09:00AM. No prior covid vaccination. No Covid tested post vaccination. Facility type vaccine was Workplace Clinic. No other vaccine in four weeks. Events resulted in none of the above. Patient was recovered in 2021. No treatment received for adverse events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021182443 same reporter, same patient, same product (different dose), different events
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| 43 | 2021-02-23 | nausea |
Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely ...
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Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely a low-grade fever; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Left arm), via an unspecified route of administration on 04Feb2021 08:15 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), on 15Jan2021 08:00 AM for covid-19 immunisation and experienced nausea, injection site bruising and pain. Patient was not pregnant. The patient experienced injection site pain, severe headache, dry mouth, mild nausea, general malaise, fatigue, nighttime sweats and likely a low-grade fever all at 05Feb2021 04:00AM. No other vaccine in four weeks. No covid tested post vaccination. Events resulted in none of the above. No treatment received for adverse events. The patient was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162107 same reporter, same patient, same product (different dose), different events.
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| 43 | 2021-02-23 | difficulty swallowing |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
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| 43 | 2021-02-24 | nausea, diarrhea |
-Diarrhea & nausea began around 2:00 p.m. on 2/23/21 - took tums and Pepto bismol, ate crackers and ...
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-Diarrhea & nausea began around 2:00 p.m. on 2/23/21 - took tums and Pepto bismol, ate crackers and drank ginger ale -Spike in blood sugar - Checked blood sugar at 3:30 (after lunch) and it was 162 (high for me). Tested blood sugar at 6:01 a.m. on Wednesday, February 24 and my fasting blood sugar was 197. -Lethargy I had to take the afternoon off and slept through the afternoon
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| 43 | 2021-02-27 | difficulty swallowing, indigestion |
Approximately 25 minutes after injection, patient reported a scratchy throat, headache, bilateral ar...
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Approximately 25 minutes after injection, patient reported a scratchy throat, headache, bilateral arm tingling, cold sensation, difficulty swallowing. MD at chairside, given Benadryl and Tylenol orally. Patient continued to have cold sensation, chilling and difficulty swallowing without water. MD ordered an additional dose of oral Benadryl. After approximately 2-3 hours of observation, patient was discharged home with spouse in no apparent distress.
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| 43 | 2021-02-27 | nausea, vomiting | Nausea, vomiting, headache, low grade fever, chills |
| 43 | 2021-02-27 | vomiting |
New and worsened reaction to food allergy/intolerance. After 20 years of small bites, I have built ...
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New and worsened reaction to food allergy/intolerance. After 20 years of small bites, I have built some immunity to certain foods. Since I received my vaccine I have had strong reactions to foods I usually tolerate with mild oral itching in very small portions. The first increased reaction was around 2 weeks after my first shot. About 2 hours after eating a very small portion of avocado, I woke up with a start with extreme tightness of my chest and gasping for air. I caught my breath after a few seconds then projectile vomited. Treated with 50mg Benadryl and returned to sleep after 45 minutes. I have never had any respiratory symptoms with a food allergy reactions. About 2 weeks after my second shot I accidentally ate a few bites of tomato which has not been a problem for over 10 years. After vomiting in my car and pulling off the road I saw my cervical lymph nodes were swollen to about 1.5 inches in diameter. I have never seen any thing like it. My airway was clear. I took 25mg of Benadryl, waited for 30 minutes, then drove home. I had a similar experience 3 weeks after my second shot with a fresh/homemade pickle that apparently was too raw. Vomiting with mildly swollen cervical lymph nodes treated with 25 mg Benadryl
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| 43 | 2021-02-28 | vomiting | 10 minutes after vaccine pt developed sob, tachycardia, vomiting - taken to ED |
| 43 | 2021-03-02 | abdominal discomfort, diarrhea |
Stuffy Nose came on and subsided within 24 hours also have had upset tummy with diarrhea on and off ...
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Stuffy Nose came on and subsided within 24 hours also have had upset tummy with diarrhea on and off since vaccine
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| 43 | 2021-03-03 | nausea |
10:15 am Started to sweat,10:25 am Started to have the chills (chills and sweats traded off througho...
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10:15 am Started to sweat,10:25 am Started to have the chills (chills and sweats traded off throughout the day and night),11:30 am migraine began to progressively get worse and continued throughout the day, 12:00 pm became slightly nauseous ate a little bit of food and it helped. Nausea gone by 12:.35 pm, (progressively slightly more fatigued than normal lasted for 2 days). Night sweats and chills throughout the night and migraine lasted until Thursday.
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| 43 | 2021-03-03 | nausea |
Sweats, nausea, muscle spasms in the injected arm for 24 hours. Spasms went away and came back a co...
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Sweats, nausea, muscle spasms in the injected arm for 24 hours. Spasms went away and came back a couple of days later and have continued off and on. On 3/3/21 a mild fever and on 3/4/21 "covid arm" at the injection site. It is red, very itchy and hard and swollen.
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| 43 | 2021-03-03 | nausea, diarrhea |
eight minutes after the vaccine I was waiting for my after dose evaluation, I started feeling numbne...
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eight minutes after the vaccine I was waiting for my after dose evaluation, I started feeling numbness on left side of my face, I was taken to the ER, it went down to the left side of my neck and my left arm, after an hour I couldn't move the entire left side of my body, they did an MRI and admitted me to overnight observation. next morning I was discharged (friday), physical therapy and occupational therapy came in to help me adjust because I was still numb I was given a walker and a knee brace, I went home. Saturday I started getting feeling in my face and neck. Sunday I was still gaining more sensation, Monday I had full sensation every where except my leg, Tuesday I had complete feeling on my entire left side. 7 days after my shot on wednesday I started having cold chills body aches and fever nausea and diarrhea, by thursday I couldn't eat anything in me I would have diarrhea. I went to the ER on Saturday, they ran tests CT scan and found entera colitis and was admitted again, they started me on iv antibiotics and fluids , no solid food, they tested my stool and everything came back normal. I was discharged because the diarrhea had stopped, I was having regular bowl movements. Dr said it may or may not have been a cause from the vaccine, they weren't sure.
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| 43 | 2021-03-03 | abdominal pain |
patient reports the first few days she experienced numbness ad tingling (2/12-2/15) to bladder and b...
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patient reports the first few days she experienced numbness ad tingling (2/12-2/15) to bladder and bilateral feet, around 2/18 her entire neck began to feel inflamed and she is still experiencing this, the neck inflammation is causing pain at a level 4 on the pain scale. Had visited the chiropractor with minimal reduction in symptoms. Has had some abdominal pain that is still present, began around 2 weeks post vaccine, this pain varies in location and is described as short lived shooting pains.
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| 43 | 2021-03-03 | abdominal discomfort, nausea |
she awakened not feeling well and began ibuprofen. Yesterday am she began with nausea, no emesis, so...
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she awakened not feeling well and began ibuprofen. Yesterday am she began with nausea, no emesis, some fatigue and body aches. She feels worse today. Pt has the pain in her right back again and it is getting worse. She feels pressure in her belly and back on the right side, no bloating. The stool is brown and light yellow today, urine is yellow.
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| 43 | 2021-03-04 | vomiting, abdominal pain upper |
11th in the evening, I suddenly had gastric pain in Stomach and was belching a lot. Then it started ...
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11th in the evening, I suddenly had gastric pain in Stomach and was belching a lot. Then it started hurting with a lot of chest pain. The pain started going behind my back and pressure and we went to ER and when I went to take my urine test and I threw up a lot. I felt pretty good after that. My reports from tests came back okay. They told me to take over the counter Prilosec and gave a prescription for Zofran.
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| 43 | 2021-03-04 | nausea |
Patient is a 43-year-old female experiencing an adverse event 15-minutes after receiving COVID-19 va...
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Patient is a 43-year-old female experiencing an adverse event 15-minutes after receiving COVID-19 vaccine. Dizzy, lightheaded, and nausea. Diagnosed as a vasovagal episode resolved without the need for treatment or medication. Patient left the facility walking on her own and with no difficulty. In summary documented as a vasovagal episode.
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| 43 | 2021-03-04 | abdominal pain, abdominal pain upper, vomiting |
Tummy ache/ gastric pain and then I threw up. This type of thing is still happening where I get the ...
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Tummy ache/ gastric pain and then I threw up. This type of thing is still happening where I get the gastric/tummy pain, etc. Two days ago it happened again. I had a doctor appt with my doctor Put me on Omeprazole. ( February 16, 2021)
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| 43 | 2021-03-07 | nausea |
Dizzy, nausea, felt warm. BP 171/114 (pulse 100), then 151/93. 98% O2 sat. Given juice, water, and r...
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Dizzy, nausea, felt warm. BP 171/114 (pulse 100), then 151/93. 98% O2 sat. Given juice, water, and rested.
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| 43 | 2021-04-01 | diarrhea, nausea |
Shingles; Shingles/she was 7 years old she had her first shingles outbreak; burning sensation; They ...
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Shingles; Shingles/she was 7 years old she had her first shingles outbreak; burning sensation; They were flu-like symptoms; Diarrhea; Nausea; achiness; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6203, Expiry Date: unknown), intramuscular, administered in the right deltoid (also reported as right arm) on 03Mar2021 16:00 at a single dose for covid-19 immunisation. Medical history included patient had anxiety all her life (ongoing), but reported 'started the medication about 10 years ago for the first time'; and patient had hypothyroidism, which she found out when she was going through the in-vitro fertilization. It was further reported that she was diagnosed with hypothyroidism when she and her husband were going through In-vitro fertilization and were having trouble conceiving and her TSH levels were off (date unknown). She didn't feel any different and didn't feel any different now since being on Synthroid; that was the only reason she found out. She was fairly healthy. Patient mentioned that when she was 7 years old she had her first shingles outbreak. Concomitant medications included oral levothyroxine sodium (SYNTHROID) taken for hypothyroidism at 75 ug, daily from an unspecified start date (approximately started 3 years ago) and ongoing; and oral sertraline hydrochloride (ZOLOFT) taken for anxiety at 50 mg, once a day from an unspecified start date (started about 10 years ago) and ongoing. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient had no prior vaccinations (within 4 weeks). Patient stated she do not want COVID and she is a pro-vaccines. Patient received first vaccine shot on 03Mar2021 and was diagnosed with shingles on the morning of 19Mar2021 and wanted to know if it was okay to take second dose of the vaccine next Thursday with active shingles diagnosis and being on antiviral medication, or should she wait. Patient stated that shingles, she was sure it was shingles, will not prevent her from getting second dose. She mentioned she was stuck, this was all new, and her doctor couldn't tell her because he didn't know. She was not sure what to do. She was not sure if she should delay getting the vaccine until she has stopped the antiviral medication, which she later clarified as Famciclovir. She stated initially her symptoms started Monday (Mar2021). They were flu-like symptoms on 17Mar2021. She was having diarrhea and feeling nauseated on 16Mar2021, thought coming down with the flu. On Wednesday (Mar2021), she felt pain, the shingles was on her buttocks. She went to the bathroom and saw red. Yesterday, 17Mar2021, she got a closer look because a burning sensation. When she looked closer, she realized it was shingles. It started more of a flu-ish feeling on Monday and noticed rash erupt on Wednesday. She also started to experience achiness on Monday (Mar2021). She was seen at her physician's office today, 19Mar2021 and was diagnosed with shingles this morning. The events shingles, nausea, diarrhea, flu-like symptoms and achiness were reported as not serious. The event burning sensation was reported as medically significant. Therapeutic measures were taken as a result of the events which included famciclovir, oral from 19Mar2021 and ongoing, at 500 mg, three times a day for shingles. The patient had not recovered from the events burning sensation (reported as worsened), shingles (reported as worsened), nausea, flu-like symptoms, and achiness. The event diarrhea was recovering. The events diarrhea, nausea, achiness, and burning sensation were reported as unrelated to the vaccine suspect product.; Sender's Comments: The events burning sensation, diarrhea, nausea and pain are considered not related to BNT162B2, but intercurrent medical conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-04-14 | vomiting |
Systemic: Vomiting-Mild, Additional Details: Patient vomited approximately 5 minutes after receiving...
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Systemic: Vomiting-Mild, Additional Details: Patient vomited approximately 5 minutes after receiving her vaccination. She stayed in the observation area for 25 minutes longer. She did not vomit again and felt well.
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| 43 | 2021-04-17 | vomiting |
This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient re...
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This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number ER8730, Expiration date: 31Jul2021), via an unspecified route of administration on 30Mar2021 at 10:00 (at the age of 43-years old) as a single dose in the right arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No lab test was performed. Prior Vaccinations (within 4 weeks) and other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as None. Patient has a few concerns, states that patient and her husband got the first dose of their Pfizer vaccines 3 days ago, on 30Mar2021, states patient is experiencing typical side effects listed like headaches and not feeling well, clarifies she turned beet red in the face right after the vaccine and sore in arm on 30Mar2021, patient had a migraine on one side of her head, felt throw uppy, woke up with a sore throat and was coughing up blood on 02Apr2021. patient states she treated herself this morning with Excedrin migraine and has completely resolved. Patient states her throat is still sore but she is no longer coughing up blood. As per the reporter seriousness criteria for the event (coughing blood) was medically significant. The outcome of the event Sore throat was not recovered, coughing blood was recovered on an unspecified date in 2021, Pain in arm, migraine, vomiting was recovered on 02Apr2021, Face red was recovered on 30Mar201 and unknown for another events. No follow-up attempts are needed. No further information is expected.
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| 43 | 2021-04-20 | abdominal pain upper |
Extreme stomach cramping and start of painful period despite having birth control that prevents it a...
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Extreme stomach cramping and start of painful period despite having birth control that prevents it and not having one for 13 years. Still ongoing.
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| 43 | 2021-04-24 | vomiting |
hospitalization due to blood diarrhea, vomiting and hypokalemia; hospitalization due to blood diarrh...
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hospitalization due to blood diarrhea, vomiting and hypokalemia; hospitalization due to blood diarrhea, vomiting and hypokalemia; hospitalization due to blood diarrhea, vomiting and hypokalemia; Worsening ulcerative colitis; Worsening ulcerative colitis; This is a spontaneous report from a contactable consumer (patient). A 43 years old female patient received BNT162B2 (lot number: EL3248) second dose on 25Mar2021 (vaccination age 43 years old) on left arm for COVID-19 immunisation. Medical history included Colitis ulcerative. Patient was not Pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received BNT162B2 (lot number: EP6955) first dose on 04Mar2021 (vaccination age 43 years old) on left arm for COVID-19 immunisation. Patient had Worsening ulcerative colitis and hospitalization (for 3 days) due to blood diarrhea, vomiting and hypokalemia. Events occurred on 26Mar2021. Patient received Potassium, Prednisone, Lialda as treatment for the events. Lab test included Nasal Swab on 30Mar2021 with result of negative. The outcome of the events was recovering.
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| 43 | 2021-04-28 | nausea |
Fainted; fell down to the ground after using restroom; I was cold; sweating; slowed heartbeat and pu...
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Fainted; fell down to the ground after using restroom; I was cold; sweating; slowed heartbeat and pulse; extreme nausea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:00 (Batch/Lot number was not reported), at the age of 43 years, as single dose for covid-19 immunization. Medical history included fibromyalgia and t5 back fracture. The patient is not pregnant. Concomitant medications included pregabalin (LYRICA); buspirone and cannabidiol (CBD OIL). On 16Apr2021 at 2 AM, the patient fainted 12 hours later and fell down to the ground after using restroom. She was cold, sweating, slowed heartbeat and pulse, extreme nausea. The patient did not receive treatment for the events. The patient had No COVID-19 prior to vaccination and had not been COVID-19 tested post vaccination. The outcome of the events fainted, fell down to the ground after using restroom, she was cold, sweating, slowed heartbeat and pulse, extreme nausea was unknown. Information about lot/batch number has been requested.
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| 44 | 2021-01-03 | vomiting | "extreme vomiting", patient left prior to being seen by physician |
| 44 | 2021-01-03 | nausea | Fever to 101.4, myalgia, extreme fatigue, headache, nausea (Pfizer-BioNTech COVID-19 Vaccine EUA) |
| 44 | 2021-01-03 | nausea |
first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong ...
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first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong headache, sore throat, very tired, coughing with pain, flushed, feel as if my eyes are on fire.
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| 44 | 2021-01-04 | difficulty swallowing |
Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushin...
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Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen
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| 44 | 2021-01-04 | diarrhea, vomiting |
Vomiting; diarrhea; This is a spontaneous report from a contactable consumer reporting for herself. ...
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Vomiting; diarrhea; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, lot # Ek5730) at single dose to right arm on 22Dec2020 for Covid-19 immunisation. Medical history and concomitant medications were none. The patient experienced severe reaction of vomiting and diarrhea on 24Dec2020, about 48 hours after vaccination, lasted about 7 hours, it went away on 24Dec2020, and she has recovered completely, but it took days to get back to normal. The outcome of events was recovered on 24Dec2020. She queried if it is safe to get the 2nd dose, if it makes her feel like the 1st one, she doesn't want it.
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| 44 | 2021-01-05 | nausea |
Nausea; Headache; Fatigue started about 5 hours after injection and seems to be getting worse; Muscl...
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Nausea; Headache; Fatigue started about 5 hours after injection and seems to be getting worse; Muscle aches-started about 5 hours after injection and seems to be getting worse; Stiff Arm; Slight pain at injection site; This is a spontaneous report from a contactable nurse, the patient. A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685), via an unspecified route of administration, in the right arm on 30Dec2020 at 06:45 AM (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included crohn's disease, ankylosing spondylitis, gastroparesis, and sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Dec2020 at 07:45 AM, about an hour after injection, the patient experience nausea and headache. Fatigue and muscle aches started about 5 hours after injection and seemed to be getting worse. The patient experienced stiff arm 12 hours after injection, and slight pain at injection site after 12 hours. The events were reported as non-serious. The patient did not receive any treatment for the nausea, headache, fatigue, muscle aches, stiff arm, and slight pain at injection site. The clinical outcome of the events nausea, headache, fatigue, muscle aches, stiff arm, and slight pain at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 44 | 2021-01-05 | nausea | Persistent migrane pain with nausea |
| 44 | 2021-01-05 | nausea | developed nausea right after taking vaccine. |
| 44 | 2021-01-05 | nausea |
immediate nausea, headache, dizziness (feeling of motion sickness) and arm pain, tiredness. ongoing ...
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immediate nausea, headache, dizziness (feeling of motion sickness) and arm pain, tiredness. ongoing headaches, fatigue, dizziness and nausea on and off every day
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| 44 | 2021-01-05 | nausea, retching | pt noted feeling chills, then developed nausea and dry heaves and sl headache |
| 44 | 2021-01-06 | nausea |
Pfizer BioNTech COVID 19 vaccine EUA- Chills, nausea, muscle aches, headache. Motrin 400 mg taken Q...
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Pfizer BioNTech COVID 19 vaccine EUA- Chills, nausea, muscle aches, headache. Motrin 400 mg taken Q4-6 hours
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| 44 | 2021-01-06 | nausea |
tingling in both hands - along ulnar nerve to 4th/5th fingers - severe - reports 8/10 discomfort BIL...
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tingling in both hands - along ulnar nerve to 4th/5th fingers - severe - reports 8/10 discomfort BILATERALLY - felt like she was going to pass out and have diarrhea and vomit at same time - these symptoms awakened her from sleep at 11:45pm; sxs lasted about 15 minutes and then abated; tingling in 4th/5th fingers BILATERALLY persists today- though much less intense - reports at level of 1/10; never did vomiting and never had diarrhea; never passed out; feeling well today - able to run 4 miles and teach yoga and work at a physical therapist
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| 44 | 2021-01-07 | decreased appetite |
FLUL LIKE SYMPTOMS SINCE 3AM 1/8/2021, CHILLS, SEVERE MUSCLE PAIN BACK NECK AND HEAD, HOT FLASHES, L...
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FLUL LIKE SYMPTOMS SINCE 3AM 1/8/2021, CHILLS, SEVERE MUSCLE PAIN BACK NECK AND HEAD, HOT FLASHES, LOSS OF APPETITE , PAIN AT VACCINATION SITE, LEFT AXILLARY PAIN ON ABDUCTION. UNABLE TO GO TO WORK DUE TO SYMPTOMS
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| 44 | 2021-01-07 | diarrhea |
Fever 100.2; headache; Body aches; Joint pain; chills; Diarrhea; Fatigue; This is a spontaneous repo...
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Fever 100.2; headache; Body aches; Joint pain; chills; Diarrhea; Fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 04Jan2021 14:00 at single dose Covid-19 immunisation. The patient was not pregnant. Medical history included hypothyroidism, tachycardia, fibromyalgia, and Covid prior vaccination. No known allergies. No Covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included unspecified medications with 2 weeks of vaccination. The patient experienced Fever 100.2, Headache, Body aches, Joint pain, Chills, Diarrhea, Fatigue on 05Jan2020 02:00. The outcome of events was not recovered. This case was reported as non-serious. No emergency room/physician office visit. No treatment received for the events. Information on the lot/batch number has been requested.
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| 44 | 2021-01-07 | vomiting, nausea |
Fever to 101.4, rigors/ chills. Nausea and vomiting. Swollen axillary lymph nodes, body aches and he...
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Fever to 101.4, rigors/ chills. Nausea and vomiting. Swollen axillary lymph nodes, body aches and headache.
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| 44 | 2021-01-07 | nausea |
I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning...
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I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning it was pounding, spread to the right half of my head, nausea, photo sensitivity, vertigo. It took 36 to 48 hours before I could function. 48 to 72 hours later I had another headache with vertigo. I had complete vision loss in my left eye.
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| 44 | 2021-01-07 | nausea |
Symptoms - ? 1/7 at approximately 2:00 pm: feelings of nausea; 10:00 pm: myalgias, midnight: chil...
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Symptoms - ? 1/7 at approximately 2:00 pm: feelings of nausea; 10:00 pm: myalgias, midnight: chills and fever (Tmax 101.3). EE denies COVID-19 exposure without proper PPE and denies travel. Home remedies? - none Any improvement? ? at time of call at approx. 9:10 am, EE reports significant improvement in symptoms and denies fever at this time Recommendation? EE encouraged to continue to monitor her symptoms and to call vaccine support line with further questions/concerns. EE verbalized back understanding and denied further questions at this time.
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| 44 | 2021-01-07 | vomiting, nausea, diarrhea |
Symptoms started 1/1/21 Pm. Headache, ear ache, chills, fever. COVID and influenza swabbed 1/5...
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Symptoms started 1/1/21 Pm. Headache, ear ache, chills, fever. COVID and influenza swabbed 1/5/21 both negative. Symptoms continued ear infection 1/6/21, nausea and chest pain. 1/7/21 vomiting and diarrhea started. Going in for COVID swab this am. And seeing a provider.
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| 44 | 2021-01-07 | diarrhea |
slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positiv...
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slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positive for covid 19 virus; feel tired; sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was Diagnosed with covid 19 virus on the 31Dec2020, she was set to have the second vaccine on the 10Jan2021. She wanted to know if she can get the second dose and if so, when. Also asked if she should get tested before taking the 2nd dose of the covid 19 vaccine. Her Adverse effects are sore arm on vaccination day (20Dec2020), and she began to feel tired on 27Dec2020 and thought that was normal. She went to a Christmas eve party 24Dec2020 and no one was masked, friend had several people from work tested positive. was tested and was positive for covid 19 virus on 31Dec2020. She also was experiencing slight cough, diarrhea (which is normal for her), shortness of breath is improving and she had no sense of smell but she was able to taste. The outcome of event shortness of breath is recovering. The outcome of other events was unknown. No follow-up attempts are possible. information about lot/batch number cannot be obtained.
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| 44 | 2021-01-08 | nausea |
Approx 16 hours after 2nd vaccination on 1/7/21, I felt nauseous. Then fever, body aches, joint pai...
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Approx 16 hours after 2nd vaccination on 1/7/21, I felt nauseous. Then fever, body aches, joint pain, severe headache. Second day I still have severe headache and nauseousness.
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| 44 | 2021-01-08 | vomiting, nausea | Dizziness, Headache & NauseaVomiting Narrative: Need to stay home due to N/V, missed work day. |
| 44 | 2021-01-08 | decreased appetite | Fever 101.2 Chills Body aches Headache Losses of appetite |
| 44 | 2021-01-08 | nausea | Headache, chills, joint and muscle pain, fever of 102, nausea, lymphadenopathy Lt Axilla. |
| 44 | 2021-01-08 | nausea |
Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days...
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Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days Severe headache x 2 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Mild headache x 1 day (OTC Ibuprofen 400mg PRN) Dizziness x 2 days (Ensured proper hydration) Body aches x 3 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Malaise x 3 days
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| 44 | 2021-01-08 | nausea, vomiting | Myalgias, fever, nausea, 2 episodes of vomiting |
| 44 | 2021-01-08 | diarrhea, nausea |
On 12-23-2020, I developed symptoms of sinus congestion along with a cough, fever, body aches and a...
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On 12-23-2020, I developed symptoms of sinus congestion along with a cough, fever, body aches and a tightness sensation in my chest. I got tested for Covid on 12-27-2020 and was positive. I also had diarrhea and nausea. I did telemedicine with my primary healthcare doctor and I discussed with him that I felt tightness with pressure sensation to my chest and he said that it was cause of my asthma and he told me to take prednisone medication.
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| 44 | 2021-01-10 | nausea, diarrhea, vomiting |
1/6/21 8pm started with Nasuea, vomiting, diarrhea and fever. 1/7/21 started having intermittent che...
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1/6/21 8pm started with Nasuea, vomiting, diarrhea and fever. 1/7/21 started having intermittent chest pain in the morning. Then in the evening it became constant. Went to ER that evening due to chest pain. EKG showed t wave abnormality. 1st Trop was negative went from 0.08 to 2.3 Had 2 Echo's done and they were normal. Platelets were 85. Was discharged without chest pain. Troponin on discharge was 0.67 and platelets 61. Was admitted due to Chest pain and troponin. Attending provider diagnosed as myocarditis and thrombocytopenia R/T vaccine.
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| 44 | 2021-01-10 | vomiting, nausea |
Both times I received the injection about 48 hours later I had a headache all over my head and naus...
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Both times I received the injection about 48 hours later I had a headache all over my head and nausea. Today I was so nauseous that I vomited about 4 times. I also noticed strangely that my birthmark on my leg which is normally a light pink had turned a very dark purple.
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| 44 | 2021-01-10 | nausea |
Next Day - Wake up with fever, chills, headache, back pain, joints pain and a little nauseous. Those...
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Next Day - Wake up with fever, chills, headache, back pain, joints pain and a little nauseous. Those symptoms last for two days. Area of vaccination was red, hot and swelled for 4 days, with left axilar ganglion and both neck ganglion swelled for 4 days too.
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| 44 | 2021-01-10 | vomiting, nausea | chills, shakes, nausea, vomiting, lightheaded |
| 44 | 2021-01-11 | diarrhea, decreased appetite |
1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a...
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1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a couple hours. Took ibuprofen which helped. Low grade fever 99.8, EXTREME weakness and fatigue, body aches devloped evening with profuse watery diarrhea 1/7-1/10, poor appetite (NO nausea, NO vomiting) also had mild symptoms of intermittent runny nose, itchy eyes, mild cough. Symptoms improved 1/11/21 with decr freq diarrhea, improvement energy level. I pushed fluids in home and ate soup. Visit to urgent care 1/11/21 for IV hydration after receiving covid testing req for job d/t symptoms. 1/12/21 feeling improvement in symptoms but not fully recovered at this time-monitoring symptoms in home
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| 44 | 2021-01-11 | abdominal discomfort, nausea |
Body aches, temperature 99.5, weak, dizzy, chills, fatigue, upper chest congestion, nausea, upset st...
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Body aches, temperature 99.5, weak, dizzy, chills, fatigue, upper chest congestion, nausea, upset stomach
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| 44 | 2021-01-11 | difficulty swallowing, nausea |
First Day after the injection I had a headache and nausea the entire day into the next day. The sec...
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First Day after the injection I had a headache and nausea the entire day into the next day. The second day I still had the headache and the nausea. I work overnights. When I awoke in the afternoon, my throat was closing up. It was hard to swallow and I struggled to breath. I immediately drank liquid Benadryl and called my doctor in the morning.
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| 44 | 2021-01-11 | nausea |
Immediately following shot developed facial flushing,nausea,dizzy. Transoported to AFM for assessmen...
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Immediately following shot developed facial flushing,nausea,dizzy. Transoported to AFM for assessment
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| 44 | 2021-01-11 | diarrhea, decreased appetite |
Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild f...
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Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild fever 99.8. EXTREME weakness and fatigue, profuse diarrhea, poor appetite, feeling morose, intermittent runny nose, itchy eyes, mild congestion and mild rare coughing spells. Please note- shot in first series was not painful- couldn't even feel shot. Only symptom after shot in 1st series was mild arm pain and mild fatigue for 2 days.
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| 44 | 2021-01-11 | abdominal discomfort, diarrhea, nausea |
On 1/8, developed diarrhea, nausea, stomach upset. Called in sick on 1/8. Symptoms improved 1/10. De...
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On 1/8, developed diarrhea, nausea, stomach upset. Called in sick on 1/8. Symptoms improved 1/10. Developed pruritus on legs, arms and posterior neck; on 1/10/2020; cannot recall time. w/ scratching becomes red. Took Benadryl last night which caused her to sleep. She reports that she had COVID PCR test performed today through CU, in the bldg. denies other symptoms, SOB, wheeze, rash. recommend that she follow-up w/ her PCP, allergist.
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| 44 | 2021-01-11 | vomiting, abdominal pain upper |
On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this ...
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On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this for at least 16 hours (very uncomfortable). Also, on January 6, 2021 at 1130pm I had horrible stomach pains, then started vomiting, after I was done vomiting I felt better. I did take 2 Benadryl and aleve to help When I got back injections and had surgeries I had the same reactions happen to me usually after 8-10 hours after I was out of surgery. I was given medicine to help with the discomfort either through IV or Benadryl.
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| 44 | 2021-01-11 | nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA Five minutes after I received the vaccine, my arm was sore and ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Five minutes after I received the vaccine, my arm was sore and my throat felt a little tight. Then, I started to feel kind of lightheaded and my legs were weak. I let the staff know and they offered me benadryl but I declined. I waited about 35 minutes then I went home. I continued to feel lightheaded and weak for about 4 hours and I also began to fill nauseous. My arm continued to be sore for a few days and I ran a fever of around 100 from the following day 1/9 and I am still running a fever now on 1/12.
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| 44 | 2021-01-11 | diarrhea |
Received the COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had involu...
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Received the COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had involuntary muscle movements and lasted for 3 days
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| 44 | 2021-01-11 | vomiting |
Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm follow...
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Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm followed by numbness and tingling (pins and needles), a few minutes later I experienced a dull headache. The arm sensation slowly subsided by the time my fifteen minutes was up. The dull headache lasted through the night Around 9 pm, I experienced chills, that lasted for 2 days with body aches and sore right and left arm. During the night, I had a hard time sleeping experiencing nightmares. Woke up at 2 am took a walk felt a little better. Chills continued throughout the night. Friday- chills continued with body aches and a general feeling of malaise. Temp was 98.7 at highest, bp 122/79, hr 80, and blood sugar 149, I have no hx of diabetes. Saturday- "hungover feeling" - headache that came in waves with a general feeling of malaise. Sunday- Pounding headache, extreme fatigue-slept until 1500 woke up and then went back to bed, body aches-worst I have felt in years. Monday shaky feeling somewhat better still malaise. Tuesday vomited all my breakfast, feeling of phlegm or something stuck in my throat. BP 120/77 hr 64 temp 98.4. Continued body aches.
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| 44 | 2021-01-11 | nausea | body aches nausea, very sore arm 1 day after i2nd injection |
| 44 | 2021-01-11 | diarrhea |
received COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had atonic rea...
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received COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had atonic reaction: involuntary muscle movements and lasted for 3 days,
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| 44 | 2021-01-12 | nausea |
About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't...
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About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't feel right." No SOB. C/o 7/10 migraine headache. Nausea but no vomiting. Frontal lobe pain. Dizzy. Felt like she was drunk. BP 136/29, HR 79. Became slower to respond to questions and a rapid response was called. Transported to ED for observation where patient received acetaminophen 975mg po x 1 and metoclopramide 10mg po x 1. Patient declined NS 1L bolus. Per ED note, patient presented with likely vasovagal episode after receiving COVID-19 vaccination. Patient's symptoms improved and patient was discharged home.
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| 44 | 2021-01-12 | nausea |
Severe bodyaches, chills, fatigue, nausea last in two days. Used Tylenol and ibuprofen to treat symp...
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Severe bodyaches, chills, fatigue, nausea last in two days. Used Tylenol and ibuprofen to treat symptoms. Still have left arm soreness on day 2 after injection . Body aches are better on the day 2 but not resolved yet, so his fatigue.
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| 44 | 2021-01-12 | nausea |
Waves of nausea starting approximately 12.5 hours after vaccine dose received. General malaise and ...
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Waves of nausea starting approximately 12.5 hours after vaccine dose received. General malaise and feeling "faint" though blood pressure, temperature, heart rate, respiration and pulse oximetry WNL.
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| 44 | 2021-01-12 | nausea |
muscle aches beginning with shoulders and neck before spreading over entire body; low-grade fever of...
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muscle aches beginning with shoulders and neck before spreading over entire body; low-grade fever of 100 degrees, chills, nausea- all lasting for about 24 hours
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| 44 | 2021-01-12 | nausea | nausea, syncope, LOC, fatigue |
| 44 | 2021-01-13 | nausea |
"my tongue got sore (not swelling), and had a cold sweat and nauseated feeling, anxious." c/o mild ...
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"my tongue got sore (not swelling), and had a cold sweat and nauseated feeling, anxious." c/o mild soreness to back of tongue. sent for obs. took zyrtec, tylenol prior to getting vaccine. eupneic, a/ox4, skin w/d. no distress" Blood pressur 160/91
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| 44 | 2021-01-13 | diarrhea, nausea |
12/23/20 - RECEIVED 1ST DOSE OF COVID-19 VACCINE IN AM FROM EMPLOYEE HEALTH CLINIC 12/24/20 EVENING ...
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12/23/20 - RECEIVED 1ST DOSE OF COVID-19 VACCINE IN AM FROM EMPLOYEE HEALTH CLINIC 12/24/20 EVENING - ACUTE ONSET OFSYMPTOMS HIGH FEVERS >101 - 103 F, SEVERE CONSTANT HEADACHES (PAIN SCALE AT 10), BODY ACHES, NAUSEA, FATIGUE, DIMISHED TASTE AND SMELL AND DIARRHEA SYMPTOMS CONTINUED TILL 1/7/2021 - SLOWLY IMPROVING
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| 44 | 2021-01-13 | nausea |
5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpita...
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5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpitations; drank a juice & some water 10 minutes later - sweats/chills, still dizzy, BP decreasing 135, agitated 20 minutes later - still sweating,/chills, head clearing, heart palpitations subsiding, Tired, legs/body very heavy. Dizzy when walking, told to rest longer 30 minutes - still sweating/chills, could only walk short distance with heavy legs and dizziness, told to rest longer 40 minutes - massive headache, slight dizziness, continued leg heaviness. nausea, light sensitive, very itchy arm. Did not feel better until 11:30 PM that night Woke in the morning with just a sore arm, runny nose and an over-all fatigue, a little cough
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| 44 | 2021-01-13 | abdominal discomfort |
Myalgia in arm of vaccination on day 0 of vaccine. Then with severe headache, myalgias, joint pain, ...
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Myalgia in arm of vaccination on day 0 of vaccine. Then with severe headache, myalgias, joint pain, upset stomach for 2 days after vaccine.
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| 44 | 2021-01-13 | nausea, difficulty swallowing |
Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness imme...
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Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness immediately after getting her first dose of the Pfizer COVID-19 vaccine at 1030 this morning. 26 minutes later the symptoms are followed by cold sweats. She feels much better now, does not now, did not have shortness of breath, nausea, vomiting, wheezing, change in voice, difficulty swallowing. Patient reports the symptoms are similar to but much milder than the symptoms she gets during rituximab infusion for her myasthenia gravis. Patient notes that she took Zyrtec and acetaminophen at 9:00 as premedication. Prior to this patient had been well, no fevers, nausea, vomiting, diarrhea, chest pain, shortness of breath, cough, sore throat, urinary problems, or other problems. Patient did not receive any additional therapy in the ED. She was observed for 2 hours in the ED and was subsequently discharged home.
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| 44 | 2021-01-13 | vomiting, diarrhea, decreased appetite, abdominal discomfort |
Per patient report: On 1/1/2021 she started to have a fever, HA, ear pain, neck pain (back of neck),...
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Per patient report: On 1/1/2021 she started to have a fever, HA, ear pain, neck pain (back of neck), and muscle aches in upper back. This continued through the weekend. On Wednesday, 1/6/2021, she saw a provider for ear pain, chest pain (radiating to right arm). She was not prescribed/given treatment regimen. On Thursday, 1/7/2021, night, she started to have vomiting diarrhea, and chest pain. On Friday, 1/8/2021, she went in to be seen for chest pain and r/o PE. States she has a history of PE and had a CT performed, no clots found. EE states does not have vomiting and diarrhea from 1/13/2021 for the first time since the start of this symptoms. Continues to have GI issues: decreased appetite and upset stomach. Also states she feels very fatigued.
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| 44 | 2021-01-13 | nausea |
THREE DAYS OF SYMPTOMS, DIZZINESS,WEAKNESS,PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN CHILLS,J...
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THREE DAYS OF SYMPTOMS, DIZZINESS,WEAKNESS,PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,SWELLING ON INJECTION SITE,NAUSEA,INFLAMATION OF NODES.
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| 44 | 2021-01-13 | nausea |
Voiced metallic taste/nausea. Inintal compliant began @ 1340. Left observation @ 1400. Denies any...
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Voiced metallic taste/nausea. Inintal compliant began @ 1340. Left observation @ 1400. Denies any other s/s of distress. No SOB/Trouble breathing as well.
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| 44 | 2021-01-14 | diarrhea, abdominal pain, indigestion |
0845 flush to chest and throat 0850 vitals checked BP: 90/60 0930 Benadryl 50 mg PO taken 1000 hives...
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0845 flush to chest and throat 0850 vitals checked BP: 90/60 0930 Benadryl 50 mg PO taken 1000 hives to left side of neck 1005 another 50 mg of Benadryl PO taken and Tylenol 650 mg PO for chills and headache 1200 famotidine PO taken for burning to stomach 1400 diarrhea and weakness. Hives had subsided 1800 another round of Benadryl and Tylenol and famotidine. Saturday at 0200 woke up abruptly itching all over. Took more Benadryl. Saturday all day medicated every six hours with Tylenol, Benadryl and Pepcid. Diarrhea continued with abdominal cramps. Sunday continued same treatment for same symptoms. Hydration was aggressive and added Bentyl. Monday, Tuesday and Wednesday symptoms continued except for the itchiness. Continued Tylenol. Diarrhea persists as well as body aches, weakness and headaches. Friday, it is now a week and I still have diarrhea and chills and weakness.
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| 44 | 2021-01-14 | diarrhea, nausea, vomiting | 8 hours after injection Chest palpitations Nausea Vomiting Diarrhea Headache |
| 44 | 2021-01-14 | nausea |
Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the c...
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Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the chills and everything; lethargic feeling; weak; Nausea; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling/left leg went numb; whole left side of face swelled up; left eye turned red; pressure in head; felt like someone squeezing her eyeball out; eye went black/left eye looked bruised/blackness around the eyes; whole face went numb/left side of face slightly numb; bells palsy; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 05Jan2021 at single dose for COVID-19 immunization. Medical history included cutaneous t-cell lymphoma from 2017 and ongoing, ongoing cholesterol, ongoing thyroid, covid-19 from Nov2020 to an unknown date not ongoing (lasted about 1-1.5 months; she did not have any breathing problems) and blood cancer. Concomitant medication included bexarotene ongoing for cutaneous T-cell lymphoma, rosuvastatin ongoing for cholesterol, levothyroxine ongoing for thyriod. The patient underwent lab tests and procedures which included COVID 19: positive in Nov2020, found out tested positive around holiday. Clinical course: onset about 26 hours after administered the first dose; onset as soon as she got back to work next day: 06Jan2021. The side effects were at their worst for at least 24-48 hours. Further described as all side effects occurred only on left side of her body: whole left side of face swelled up on 06Jan2021; left eye turned red on 06Jan2021; whole face went numb/left side of face slightly numb on 05Jan2021; eye went black/left eye looked bruised on 05Jan2021; pressure in head on 06Jan2021; felt like someone squeezing her eyeball out on 06Jan2021, within the first 24-48 hours, her 'left leg went numb'. She called to talk to physician and nurse who advised her to take Benadryl; which she did take and the Benadryl stopped the side effects; but she could not take a lot of Benadryl or anything because she was at work. She stayed at work because at least there were healthcare professionals, adults in case she passed out; at home she has 7 young children and is also raising her grandchild. The side effects did not completely go away. The arm thing was normal; The next day she was at work and had the swelling on left side of face; blackness around the eyes; arriving home she had headaches on 07Jan2021 and then her leg went numb for like 20 mins; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling that she started panicking because she was driving on 06Jan2021. She calmed herself down thinking it's only the left side; you can drive with your right side to get home and be fine. It was more like left side of her body was asleep, tingling, she has never had that happen before. Everything else like the headache, flu feeling was about 48 hours later (on 07Jan2021). She had COVID already back in Nov2020 for about 1-1.5 months; the next side effects she had were like the COVID symptoms she had, like the chills and everything on 06Jan2021. She had the lethargic feeling again, her head was hurting, she felt extremely weak on 06Jan2021. Patient also felt nausea on 06Jan2021, Dizzy on 08Jan2021. Another doctor said it sounded like the side effects she experienced with the vaccine sounded like allergic reaction or Bell's palsy. Patient was asking the doctor if she could get like an Epi-pen or prescription Benadryl or something because she is afraid to get the second dose of Pfizer COVID-19 Vaccine and not have something to respond to side effects with. The outcome of event whole face went numb/left side of face slightly numb was recovered on 07Jan2021, for headaches was recovering, chills and nausea was recovered on 08Jan2021. Outcome of other events was unknown. Information about lot/batch number has been requested.
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| 44 | 2021-01-14 | nausea | Nausea, Dizziness, anxiousness, elevated Blood pressure, dry mouth, tachycardia |
| 44 | 2021-01-14 | nausea |
Severe side effect post 2nd covid vaccine. Started about 9-10 hours post vaccine. Fever (101.9+ F) ...
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Severe side effect post 2nd covid vaccine. Started about 9-10 hours post vaccine. Fever (101.9+ F) Rigor Severe body aches Severe headache Nausea
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| 44 | 2021-01-15 | decreased appetite |
2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a hea...
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2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a headache and felt tired so took some melatonin, had a hot toddy, and went to bed early. Woke up roughly 18 hours post vaccine with back aches and lower rib pain when I took a breath. Took my temp, it was 100*. By 21 hours I had a temp of 102*. My groin, neck, and left arm pit lymph nodes were enlarged as well. After sleeping most of the day away, it felt like my fever 'broke' at 28 hours, it came down to 101*. Finally I took some Tylenol at 34 hours so I could sleep from the back pain. Woke up the next morning at 45 hours with a stiff back/neck but temp down to 99*. I also had a swollen and reddened entire deltoid where the shot had been given (painless when shot given and no blood after), almost like a cellulitis or allergic reaction. My left armpit lymph node remains enlarged but not as painful. Now almost 72 hours out, the only residual effects are a decreasing but enlarged left armpit lymph node, improving swollen/reddened deltoid, decreased appetite, and decreased energy level.
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| 44 | 2021-01-15 | difficulty swallowing |
About 10 mins after injection, felt chest tightness, palpitations, b/p 168/118. Then developed heada...
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About 10 mins after injection, felt chest tightness, palpitations, b/p 168/118. Then developed headache, dizziness, felt something stuck in throat and difficult to swallow. Also acid reflux. Sent to ER. B/P 170/98, still had feeling of difficulty swallowing, headache and acid reflux. Was given Tylenol, Pepcid and Ativan. After several hours B/p was normal and had slight headache when I went home. Following day felt tired and still with headache. Tylenol not helping.
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| 44 | 2021-01-15 | vomiting, nausea | Headache, Myalgia, Fever, NauseaVomiting, fatigue, sore arm Narrative: missed work 1/8/2021 |
| 44 | 2021-01-15 | nausea, vomiting | Myalgia, Fever, NauseaVomiting, fatigue Narrative: |
| 44 | 2021-01-16 | nausea | Extreme lethargy, nausea, ?foggy brain? |
| 44 | 2021-01-16 | nausea |
Within hours of receiving vaccine had headache, took Ibuprofen and went to bed early. When woke up s...
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Within hours of receiving vaccine had headache, took Ibuprofen and went to bed early. When woke up still had headache, as the morning went on developed muscle aches, chills, nausea, fatigue and aching joints. These symptoms lasted for 48 hours, and were debilitating. Took Tylenol q6 hours.
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| 44 | 2021-01-17 | vomiting |
Symptoms began January 10, 2021, and included severe vertigo / dizziness with vomiting. Symptoms ha...
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Symptoms began January 10, 2021, and included severe vertigo / dizziness with vomiting. Symptoms have persisted, despite treatment with antivert, zofran, and phenergan. I am unable to walk without assistance. I am unable to drive and unable to work at this time.
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| 44 | 2021-01-18 | diarrhea |
1/17 headache, fever, fatigue 1/18 headache, sore throat, fever, fatigue 1/19 diarrhea, headache, so...
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1/17 headache, fever, fatigue 1/18 headache, sore throat, fever, fatigue 1/19 diarrhea, headache, sore throat, fever, fatigue
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| 44 | 2021-01-18 | diarrhea, nausea |
Approx 10hours post vaccination, headache, nausea, dizziness, chills, fever, body aches, joint pain ...
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Approx 10hours post vaccination, headache, nausea, dizziness, chills, fever, body aches, joint pain lasting approx 30 hours. Followed by diarrhea lasting an additional 48hours.
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| 44 | 2021-01-18 | nausea |
Day 1: soreness at the site of injection (left arm) Day 2: extreme fatigue, whole body muscle aches,...
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Day 1: soreness at the site of injection (left arm) Day 2: extreme fatigue, whole body muscle aches, whole body joint aches, chills, fever (100.3), headache Day 3: none Day 4: headache and nausea Day5: symptoms have resolved
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| 44 | 2021-01-18 | diarrhea, vomiting, nausea |
Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fev...
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Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fever; Headache; really sore right arm; right arm felt numb; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (Pfizer COVD 19 vaccine), lot number: EL0142, via an unspecified route of administration on 07Jan2021 17:00 at single dose in right arm for COVID-19 immunisation. Medical history included blood pressure abnormal, had a cough from having COVID 19 on 16Dec2020, cough was ongoing and unknown for COVID-19. Concomitant medication included amlodipine from an unspecified date (taking for 2 years) and ongoing at 10mg once daily by mouth for blood pressure abnormal. No other vaccines were administered on same date and no prior vaccinations (within 4 weeks). Registered nurse (patient) was calling regarding Pfizer COVID 19 vaccine. Reported she received the first dose last Wednesday 07Jan2021 17:00 in the right arm. Reported she noticed the next day (08Jan2021) fever and a headache. On 08Jan2021, Friday she had a really sore right arm and her right arm felt numb. On 09Jan2021, Saturday, she experienced nausea and vomiting and also noticed a rash on her right arm, like a hive or whelp. On 10Jan2021 Sunday, again with the fever, nausea, vomiting and she had diarrhea. Today she stated she woke up a new woman. She feels felt with no fever and her arm was better. She still had a cough from having COVID 19 on 16Dec2020. Stated she was used to coughing. Added she treated the fever with Tylenol 1000mg. Stated she didn't remember exactly but she took a little everyday starting on Thursday the day after the vaccine. Stated she was unsure if she would have the next dose. The events didn't require a visit to physician office or emergency room. The outcome of fever was recovered on 10Jan2021, of Headache, sore arm, rash on right arm, nausea and vomiting was recovered on 11Jan2021, of arm numb was recovered on 09Jan2021, of diarrhea was recovering. Serious criteria for fever was reported as yes, medical significant, for Headache, sore arm, arm numb and Diarrhea was non-serious, for rash on right arm, nausea and vomiting was unspecified.; Sender's Comments: Based on the compatible time association, the event fever is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-01-18 | nausea |
I had moderate reaction to first vaccine where I had to go to the ER, for rash on my arm and chest/b...
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I had moderate reaction to first vaccine where I had to go to the ER, for rash on my arm and chest/back, increase blood pressure and chest pain. Pepcid, benadryl and prednisone were given to me in the ER and a liter of fluids. VAERS number Date Form Completed: 01/06/2021 Temporary VAERS E-Report No: 223935 So on the second dose, I premedicated the night before 8pmwith 20mg of prednisone, 10mg of claritin, and 40mg of pepcid. In the morning 9am I took 40 mg of pepcid, 20 mg of predisone and 30 minutes prior to second vaccine around 12pm, I took 25mg of benadryl. After vaccine , I had severe nausea at about 20 minutes (1240p), and increase blood pressure at about 30 to 40 minutes. 156/94 was my highest. I had fewer areas of itching and specks of rash and itching around my back than on the first dose that I took. If I did not premediate, I am sure I would have had a similar or worse reaction since I still had similar reaction but milder.
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| 44 | 2021-01-18 | difficulty swallowing | Systemic: DIFFICULTY SWALLOWING AND FELT LIKE THROAT CLOSING |
| 44 | 2021-01-19 | diarrhea, vomiting, nausea | Diarrhea, vomiting, and nausea |
| 44 | 2021-01-19 | nausea | Headache, pain in left arm, fever, chills, body aches, nauseous, fatigue |
| 44 | 2021-01-19 | vomiting | migraine, fever, sweat, body aches, vomiting |
| 44 | 2021-01-21 | diarrhea |
48 hours after vaccine, at 3 pm, I developed an allergic response. I had diarrhea, hives, itchy eyes...
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48 hours after vaccine, at 3 pm, I developed an allergic response. I had diarrhea, hives, itchy eyes, mouth, and throat, coughing, and slight constriction in my lungs. Within 30 minutes of taking Benadryl the symptoms began to subside. After the allergic reaction, I developed the normal symptoms of the vaccine with chills, fever, body aches and a headache. Injection site had increased soreness for the rest of the day.
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| 44 | 2021-01-21 | abdominal discomfort |
Dry mouth, extreme thirst, digestive distress. Onset approximately 12 hours post injection. Lasting ...
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Dry mouth, extreme thirst, digestive distress. Onset approximately 12 hours post injection. Lasting until the next day. Resolved over time.
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| 44 | 2021-01-21 | abdominal pain, nausea |
Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye...
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Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye bloody Abdominal pain for 3 days unable to sleep due to discomfort Nausea off and on for 3 days with abdominal pain Fatigue Faint with abdominal pain Light headed off and on
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| 44 | 2021-01-21 | nausea |
Started with flushing. Recieved 25mg Bendaryl po, which did not seem to help. progressed to nausea, ...
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Started with flushing. Recieved 25mg Bendaryl po, which did not seem to help. progressed to nausea, some SOB, received epi, then started to break out. Prepare to take to BMC. Another dose of epi was given prior to transport. BP 176/106 HR 84 P 22
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| 44 | 2021-01-22 | nausea |
About 10 min after injection I began to feel dizzy, then had 1 faint wheeze at the base of my chest,...
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About 10 min after injection I began to feel dizzy, then had 1 faint wheeze at the base of my chest, I became nauseous, then developed rapid palpitations. I BP was checked about 10 min later and I was hypertensive SBP 180s. By the HR was down to about 90 bpm and I felt the palpitations begin to decrease. I was feeling better by about 10 min later and went home. I also had itchiness of the L hand for about 1 hr afterwards.
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| 44 | 2021-01-24 | nausea, abdominal pain |
1 pm was vaccine admin time on Wed (1/20). By 8 pm, her arm was very sore & with significant fatigue...
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1 pm was vaccine admin time on Wed (1/20). By 8 pm, her arm was very sore & with significant fatigue. 1am that night, awoke with chills, fever (102), generalized muscle aches. By midday Thursday, these symptoms began to dissipate slightly and she developed a h/a. Friday, fever, chills, h/a were gone & nausea and abdominal pain started. No vomiting or diarrhea occurred. By SAturday evening, nausea improved but upper legs became tremulous and weak. Weak, tremulous legs have continued and persist up until today (monday, 1/25).
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| 44 | 2021-01-24 | difficulty swallowing |
After patient received vaccine she C/O tingling face was given Benadryl @1341 , 15 minutes later pa...
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After patient received vaccine she C/O tingling face was given Benadryl @1341 , 15 minutes later patient was C/O tight throat, Solumedrol 60mg IM administered to Rt buttocks by this nurse. Pt then escorted to ER for further evaluation. On 1/25/21 at 1359: Patient reported tingling of lips and throat felt tight. SPO2 via finger with a result of 99%. Emergency room provider's note: 44-year-old female patient presents ED after allergic reaction. Patient received her first COVID-19 vaccination and during the 15-minute observation period began to feel as if she had some tightness in her throat and difficulty swallowing. She has a scratchy sensation to her posterior pharynx. She denies specifically shortness of breath, nausea vomiting, dizziness or near syncope. She was medicated with 50 mg of Benadryl p.o. as well as 60 mg of Solu-Medrol IM prior to arrival. She states she has never previously had allergic reactions to vaccinations in the past
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| 44 | 2021-01-24 | nausea |
Woke up from sleep at 3:02am (13hrs post injection) Severe headache (most prominent at base of neck,...
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Woke up from sleep at 3:02am (13hrs post injection) Severe headache (most prominent at base of neck, behind eyes, and top of head) throbbing pain. Hurt to move eyes. Photosensitivity (eyes must remain shut at all times) Nausea, fever (102.3), sweats, chills Severe body aches (most prominent in lower back, hips, and legs/knees) Tylenol/ibuprofen alternating (reduced pain down to 4/10) 1st applied ice to lower back and surrounded head. This allowed me to sleep for almost 4 hours. Then applied heat to lower back. Continued to drink normally and eat bland diet These symptoms lasted all day. Around 11:30pm on 1/25 symptoms resolved with the exception of a headache requiring ice packs again throughout the night and tylenol. 9:22am today, still mild headache and get dizzy or a vertigo feeling if I change position too quickly or rotate my head too quickly
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| 44 | 2021-01-25 | nausea | 1hr after - Headache, nausea. 2nd day - body aches and chills |
| 44 | 2021-01-25 | vomiting | Cough, vomiting, hives, pain to neck and back and left wrist |
| 44 | 2021-01-25 | nausea |
I started running a mild fever the next day and I still have a fever today; feel lightheaded; weak; ...
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I started running a mild fever the next day and I still have a fever today; feel lightheaded; weak; feeling nausea; my legs were weak; my throat got tight; This is a spontaneous report from a contactable HCP. This 44-year-old female (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm at single dose for COVID-19 immunization on 08Jan2021 05:30 PM. Relevant medical history included osteoporosis and menopause. Known allergies included: soy, dairy, all nuts, sunflower, cottonwood, lentils, chickpeas, Vit E, cephalexin, Amoxicillin, sulfa, Bactrim, lisinopril , estrogen, moxifloxacin, Pseudoephedrine, paroxetine, trimethoprim, doxycycline, azithromycin, cipro, clindamycin, colestipol. The patient was not pregnant. Relevant concomitant drug included Vit D, calcium, ibuprofen. Five minutes after receiving the vaccine, her throat got tight then she started to feel lightheaded and her legs were weak. She notified the staff there who offered her Benadryl but she declined. She began feeling nausea about an hour later and she felt lightheaded and weak for about 4 hours. She started running a mild fever the next day and she still had a fever on 12Jan2021. The patient did not receive other vaccine in four weeks. The outcome of events was recovering. No treatment was received. The patient was not COVID infected prior vaccination. The patient did not have COVID tested post vaccination.
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| 44 | 2021-01-25 | decreased appetite, diarrhea, nausea | Nausea, loss of appetite, muscle aches and fatigue beginning on 1/21. Diarrhea beginning on 1/22. |
| 44 | 2021-01-25 | vomiting, nausea |
had a massive headache; nausea; throwing up for a couple of hours; This is a spontaneous report from...
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had a massive headache; nausea; throwing up for a couple of hours; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, Expiry Date: 30Apr2021), via an unspecified route of administration on 11Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient had the vaccine yesterday on 11Jan2021 at 12:00. Then by 3:30pm on 11Jan2021, patient had a massive headache, nausea, and throwing up for a couple of hours. She saw nausea as a side effect, but not the others. She also didn't think there were side effects really after the first shot. The patient asked if these are reported side effects after first dose and what about 2nd dose? Should there be any issues after the 2nd dose?. She is an ophthalmic tech. She doesn't have a prescribing doctor. She got it with the (health department name) for healthcare workers. The nausea stopped last night (recovered) at 10PM on 11Jan2021, and her headache stopped (recovered) at 9 am this morning on 12Jan2021. The patient also recovered from the event 'throwing up' on 11Jan2021.
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| 44 | 2021-01-26 | diarrhea, vomiting | Cold chills, fever, throwing up,diarrhea,extreme headache and body aches |
| 44 | 2021-01-26 | nausea, diarrhea |
Diarrhea, nauseated, headache, fever, arm pain, body aches, chills, joint pain, skin burning, facial...
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Diarrhea, nauseated, headache, fever, arm pain, body aches, chills, joint pain, skin burning, facial redness, left chest wall swelling and tenderness. Seen Dr today
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| 44 | 2021-01-26 | nausea |
Observed for 30 minutes. Flushing, arm heaviness reported, nausea, heat in thighs. Reports similar ...
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Observed for 30 minutes. Flushing, arm heaviness reported, nausea, heat in thighs. Reports similar reaction with first dose. Requested to rest on a stretcher. BP 140/71, HR 93. Nausea and arm heaviness reported at 1605. BP 150/81, 10015sats; HR 87. At 1610 Heat in thighs. BP 125/66, HR 82 100% sats on oxygen. 1628: No further symptoms. Released home.
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| 44 | 2021-01-26 | diarrhea | headache, lightheadedness, fatigue, joint pain, diarrhea, normal vaccine site tenderness, chills |
| 44 | 2021-01-27 | abdominal pain upper |
Starting the day after the vaccine she had body aches, sore arm, stomach ache and lost her voice. Sy...
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Starting the day after the vaccine she had body aches, sore arm, stomach ache and lost her voice. Symptoms lasted 2 days.
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| 44 | 2021-01-27 | nausea | The day after the injection she had a low grade fever, nausea, headache, fatigue and lightheadedness |
| 44 | 2021-01-28 | diarrhea |
1/26--diarrhea, 1/27--hives on face and eyes, diarrhea has worsened, 1/28--itchy throat, SOB, rash o...
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1/26--diarrhea, 1/27--hives on face and eyes, diarrhea has worsened, 1/28--itchy throat, SOB, rash on face, watery stools, 1/29--rash has resolved with benadryl, still severe diarrhea
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| 44 | 2021-01-28 | nausea |
2nd Vaccination shot administered on 1/23. Fevers up to 103.3, nausea and head/body aches for over ...
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2nd Vaccination shot administered on 1/23. Fevers up to 103.3, nausea and head/body aches for over 72 hours; Still with intermittent fever, malaise and headache 1/27.
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| 44 | 2021-01-28 | vomiting, nausea |
Had the common side effects: headaches, fevers up to 101.5, severe body aches, fatigue in the the mo...
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Had the common side effects: headaches, fevers up to 101.5, severe body aches, fatigue in the the morning after the shot, but also had concurrent severe vomiting and nausea. Vomited approximately 20 times day after the vaccine, starting about 18 hours after the vaccine. Other symptoms were present about 13-14 hours after the vaccine. Vomited continued for 14 hours. Severe nausea continued for 2-2.5 days. No diarrhea. No abdominal pain. Too weak to drive to the ER. Had Zofran at home and took 8 mg of Zofran ODT every 4-6 hours for 36 hours beginning with the onset of vomiting. Missed 3 days of work but was able to orally rehydrate.
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| 44 | 2021-01-28 | nausea | Headache, dizziness, burning tingling lips, nausea, rash on chest, drop in blood pressure |
| 44 | 2021-01-28 | nausea |
My face was bright red and very hot and swollen cheeks I felt nauseous Very bad headache Very thi...
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My face was bright red and very hot and swollen cheeks I felt nauseous Very bad headache Very thirsty
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| 44 | 2021-01-28 | abdominal pain |
Patient reports pain/discomfort in chest and abdomen shortly after vaccine. States she experienced ...
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Patient reports pain/discomfort in chest and abdomen shortly after vaccine. States she experienced shortness of breath, headache, and fatigue for 2 weeks after vaccination. A day after vaccine, reports multiple episodes of subjectively bloody diarrhea. An evaluation by GI showed now abnormal findings. Patient tested for COVID and was negative. Advised not to get second dose of vaccine.
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| 44 | 2021-01-31 | nausea |
Approximately three hours after injection the lymph node in the armpit closest became swollen and ar...
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Approximately three hours after injection the lymph node in the armpit closest became swollen and arm was sore. Administered Tylenol. At approximately midnight woke up with severe chills, fever (103) , Body pain, Severe eye pain and nausea. Developed a headache and sweating throughout the night. Continued to administer Tylenol at regular intervals. Sweating was profuse in that pajamas needed to be changed twice. At this point it has been more than 24 hours and though the symptoms have reduced in severity, eyes are still very sore and still experiencing chills and low-grade fever off and on. I would?ve gone into urgent care but there was a huge snowstorm. The reaction was quite concerning and very surprising. There was literally only a sore arm and mildly at that from the first injection .
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| 44 | 2021-01-31 | nausea | Headache, Fevers , Body aches, Nausea, Arm Pain |
| 44 | 2021-01-31 | difficulty swallowing |
Patient described arm pain at the site of injection soon after injection. Began to develop difficult...
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Patient described arm pain at the site of injection soon after injection. Began to develop difficulty swallowing, which the patient described as her tongue feeling heavy and her throat feeling tight. Adult EpiPen was administered at 10:33 AM with PO diphenhydramine 25 mg immediately after. Symptoms resolved. Patient was tachycardic (~100) and hypertensive 140/100. EMS arrived and brought patient to emergency department for additional testing/monitoring.
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| 44 | 2021-01-31 | abdominal pain |
Severe lethargy for about 12 hours, severe abdominal cramping for about 72 hours Moderate-severe arm...
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Severe lethargy for about 12 hours, severe abdominal cramping for about 72 hours Moderate-severe arm pain at injection site and all down arm for about 24 hours
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| 44 | 2021-01-31 | abdominal discomfort |
Soreness at injection site within 1 hour. Swelling at injection site within 1 hour pain and swelling...
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Soreness at injection site within 1 hour. Swelling at injection site within 1 hour pain and swelling continued until Thursday (4 days later). Feeling ?off? or unwell without any other symptoms -3 hours after injection and lasted until 5:00pm next day when symptoms increased. Starting 5:45pm Lethargy, shaking all over, feeling of ?freezing ?, upset stomach, fever of 101- continued into the evening. Fever resolved with Advil and rest. Shaking and upset stomach stopped sometime overnight. Feeling very tired next day.
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| 44 | 2021-02-03 | diarrhea, nausea |
Dizziness, nausea, Fainting, extreme headaches, brain fog, impacted depth perception, extreme muscle...
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Dizziness, nausea, Fainting, extreme headaches, brain fog, impacted depth perception, extreme muscle pain, knots in large muscles, diarrhea.
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| 44 | 2021-02-03 | difficulty swallowing, vomiting, nausea, diarrhea |
This is a spontaneous report from a contactable nurse patient herself. A 44-year-old female patient ...
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This is a spontaneous report from a contactable nurse patient herself. A 44-year-old female patient received the second dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284, expiry date 30Apr202), via an unspecified route of administration (right deltoid), on 07 Jan 2021 11:00, at single dose, for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899, expiration date 31Mar2021) on 21Dec2020 for covid-19 immunization at 44-years-old. The patient reported that she got the shot. After the first dose received on 21Dec2020 she was fine and experienced no problems but; after the second dose received on 07Jan2021 she had a headache and she didn't go to work. The next day after the second shot she had fever and felt sick on 08Jan2021 and she wasn't going to call about that but then, less than a week later, on Jan2021 she had a stomach virus. She was not sure if it was a stomach virus or something related to the vaccine. She was not going to call but her dad said, "Well they won't know if you don't tell them so you could tell them and maybe see if other people have had that associated with it or not." So, she was going to see in the reporting information if other people had this issue or if it was just like a fluke GI bug that happened soon after she got the shot. She got the second shot on Thursday 07Jan2021 and then on Friday 08Jan2021 she stayed home with fever. On 09Jan2021 she felt fine and headache was recovered. Then the following Thursday 14Jan2021 she woke up at 1AM throwing up and having diarrhea. If it was a GI bug on 14Jan2021 it was the worst GI bug she ever had and right now she doesn't know but she went through the whole process of a GI bug. She couldn't eat anything for a day on Jan2021. She was barely able to drink water on 15Jan2021. She felt better that weekend and she was only eating soup and crackers, but she felt better. But then as soon as she added something else to her diet besides soup and crackers, she started feeling sick again, it did not go well. She was still only able to eat soup and crackers and feels very nauseated on Jan2021 all the time. She would like to know if this was a common reaction from the vaccine. That was on Sunday night 17Jan2021 that she started to feel sick again. On Monday she went to work but they only worked a half day and she was thankful because the only thing she wanted to do was come home and take a shower and go to bed. It had continued from there, still to the point that she said she would go get tested for COVID because she was exposed to a person that tested positive for the virus between her second dose and the first dose. A person very close to her tested positive and then she was around that person for week, it was her fiance. She still got the second shot and she was hopeful that she wouldn't get it; they were careful and wore a mask and everything. She informed that she got COVID-tested yesterday 19Jan2021 and she got this "app thing" but she was unsure about the accuracy of the (state name) health app and the app says her COVID test was negative but her work hasn't called her yet to confirm that it was negative so she was not sure if the app was legitimate. With the (state name) health app she was thinking it would be random they are sending texts to her phone so; they knew that she got a test. She also had an antibody test on an unspecified date after she received her vaccine (unknown which dose) and it was negative; she would like to know if this meant it was not effective. She stated she has never had a GI bug linger like this one. Her stomach was still gurgling in Jan2021, and she was still eating soup and crackers and it has been a week. As for her primary care, she hasn't seen them in a while, she can just skip that. She stated she started feeling sick with the GI bug symptoms on 14Jan2021. She got her second dose on 07Jan2021 and then, on 08Jan2021 was when she was sick with the fever. By that Saturday 09Jan2021 the fever was gone. Then on 14Jan2021 the GI bug symptoms developed. She says the diarrhea and vomiting have stopped; her stomach was just gurgling and she can't eat anything except soup and crackers. The vomiting and diarrhea started and ended on 14Jan2021, but she stopped eating and drinking; so, once everything came out that was the end of that. She just has not gotten back to normal. She says she would not say recovered with lasting effects because she does not think she has recovered at all. She would just say she still has not gotten back to normal. Vaccine Supplemental Form: Pfizer Suspect Vaccine and Vaccination Details. Time the Vaccination Was Given: 07Jan2021 at 11 AM. Anatomical Location of Administration of Pfizer vaccine considered as suspect: right deltoid. Vaccination Facility Type: Hospital as an employee. She remembers it was 4AM that she woke up with fever on 08Jan2021 she already had started taking Tylenol because she didn't want to get anything, and she didn't take any more after dinner on 07Jan2021. She thought she would be fine at that point, but she woke up at 4AM on 08Jan2021, sweating and not feeling good, just feeling sick. Vaccine Administered at Military Facility? No. History of all previous immunization with the Pfizer vaccine considered as suspect: First dose on 21Dec2020. She also has another question before she got the second shot. She asked the lady when she went to get it too. She stated her fiance got sick 29Dec2020 and apparently it came out later that he was exposed on 27Dec2020. She didn't see him until 30Dec2020. He started showing symptoms on 29Dec2020 and then on 30Dec2020, he got tested and she saw him, then he stayed with her because he lives with his elderly parents. He stayed there and they had talked about it before that he would come there to stay with her if he tested positive. She just thought she could handle it better than his parents and she already had the first vaccine but then she was around him 30Dec2020 then got her second dose on the 07Jan2021. Her question was, was there a problem that she was around someone that had COVID. The lady she asked said as long as she doesn't have symptoms, it was not contraindicated. She was told that if she has active symptoms, she should not get it. Since she was not having symptoms, the lady told her it was up to her and she could take it if she wanted it. She wanted to know could that be why she was having these issues because she was around someone with COVID. She further stated that if her COVID test truly does come back negative and her stomach does not straighten out, then she will have to go to the doctor. Also, she stated that they may want to test her for a GI bug or food poisoning, but nothing has been done at this time. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient recovered from headache and fever on 09Jan2021; recovered from throwing up/vomiting and diarrhea on 14Jan2021; had not recovered from GI bug; and recovering from couldn't eat anything for a day and barely able to drink water. The outcomes of the other remaining events were unknown.
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| 44 | 2021-02-04 | vomiting, nausea |
Chills at 9pm (10 hours after vaccine). Chills continued for 2 days. Muscle and body aches, nausea, ...
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Chills at 9pm (10 hours after vaccine). Chills continued for 2 days. Muscle and body aches, nausea, dizziness, tiredness, very sore at injection site, started at 8am the next day and continued for 3 more days. Vomited twice on day 3
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| 44 | 2021-02-04 | nausea |
Nausea immediately after injection, joint and muscle pain, sharp back spasms shortly , site soreness...
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Nausea immediately after injection, joint and muscle pain, sharp back spasms shortly , site soreness, mild headache
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| 44 | 2021-02-04 | vomiting |
Patient reported seafood allergy. She was instructed to wait 30 min post vaccine for monitoring. 20-...
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Patient reported seafood allergy. She was instructed to wait 30 min post vaccine for monitoring. 20-25 minutes post, patient said she had to go to the restroom. She was vomiting in the restroom for 5-10minutes. She was responsive. She drank water and sat in the bathroom for 5-10 minutes and then back into the observation room for another 15-20 minutes.
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| 44 | 2021-02-04 | nausea |
low blood pressure; pale and diaphoretic; pale and diaphoretic; Pain injection site; nausea and feel...
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low blood pressure; pale and diaphoretic; pale and diaphoretic; Pain injection site; nausea and feeling faint; nausea and feeling faint; This is a spontaneous report from a contactable nurse and a contactable consumer. A 44-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3247, Expiration Date: 31May2021), via an unspecified route of administration on 19Jan2021 at 14:00 at 0.3 mL, single on deltoid left for covid-19 immunisation. Medical history included panic attack. There were no concomitant medications. Patient received the vaccine on 19Jan2021 at around 14:00 in her left deltoid. Pain at injection site started at 14:10 on day of injection, patient came to observation area with pain at injection site, nausea and feeling faint. After that, the nurse in observation area took blood pressure (BP) at 14:12 and blood pressure was 88/60 and pulse was 78 and O2 sat 88 on room air, pale and diaphoretic at this time. Treatment: patient legs elevated, offered juice and water. Patient was able to swallow. Nurse in observation placed call to 911 at this time. 14:17 BP rechecked 118/82 and pulse was 78 and Sat 98% and starting to feel better. 14:20, blood pressure was taken again 120/84 pulse 80 and O2 Sat 98%, patient was returned to upright position and stated they felt so much better, cancelled EMS (Emergency Medical Services). Patient stated at this time that she had a history of panic attacks and she felt that she worked herself thinking about the vaccine. Did call doctor in charge of clinic and checked out the patient. Checked on patient the following day and stated that she was fine and going back to work. Outcome of the events was resolved.
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| 44 | 2021-02-15 | vomiting |
Severe dizzyness, vomiting, tongue swelling,. Took ambulance to hospital. Stay at hospital 6 hours. ...
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Severe dizzyness, vomiting, tongue swelling,. Took ambulance to hospital. Stay at hospital 6 hours. Started at home for there days from work. Tongue and throat are still sore.
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| 44 | 2021-02-21 | nausea |
About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that...
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About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that way for several hours. 2 days later my arm felt like someone was hitting it over and over with a needle. I had numbing pain in my shoulder and back. I felt nauseated. It has been over a week and I still have pain at the injection site and have body aches. I am unsure who to contact and am not sure what I should do.
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| 44 | 2021-02-21 | nausea |
Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed...
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Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed swelling in my right breast and lymph nodes in my right armpit. It is painful to the touch and swollen to the size larger than a golf ball. Pain radiates down my inner arm to my forearm.
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| 44 | 2021-02-21 | nausea, vomiting |
Shot 2-Nausea; vomiting; couldn't eat or drink; headache; skin pain; This is a spontaneous report fr...
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Shot 2-Nausea; vomiting; couldn't eat or drink; headache; skin pain; This is a spontaneous report from a contactable other HCP. A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Jan2021 18:00 (at the age of 44 years old) at single dose for covid-19 immunisation. Medical history included vestibular problems, allergies Cipro, migraines, concussion, all from an unknown date and unknown if ongoing. Concomitant medication included budesonide (BUDES), levocetirizine dihydrochloride (XYZAL), montelukast sodium (SINGULAIR), nortriptyline, olopatadine. The patient previously took cipro [ciprofloxacin] and experienced allergies. Patient also had BNT162B2 dose 1 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) lot unknown, on 02Jan2021 at 11:45 AM on left arm. The patient did not have any other vaccines in four weeks. The patient has not had covid-19 prior to vaccination. The patient experienced " Shot 2-Nausea, vomiting, headache, skin pain, couldn't eat or drink" on 23Jan2021 09:00 with outcome of recovering. The events resulted patient in Emergency room/department or urgent care. Patient was also received IV fluids, nausea medication, 2 pain medications for headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Jan2021. Therapeutic measures were taken as a result of the events. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Nausea, Vomiting, and Eating disorder cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-02-21 | vomiting, nausea |
Started with nausea and Headache the day of the vaccine shot. The following day I had nausea, throwi...
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Started with nausea and Headache the day of the vaccine shot. The following day I had nausea, throwing up, light-headed, and actually blacked out momentarily. Treatment included: taking Excedrin for Migraines and an anti nausea medication. I slept for most of the day following the shot and the entire night the next day and the next night. All total sleep was probably a total of 25 - 30 hours of a 48 hour period following the vaccine. Still feeling nauseous and having headaches five days after taking the shot.
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| 44 | 2021-02-22 | vomiting |
5:30pm 2/22/21 started feeling ache ate dinner: 7:30pm started vomiting with fever of 100: 9pm sever...
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5:30pm 2/22/21 started feeling ache ate dinner: 7:30pm started vomiting with fever of 100: 9pm sever chills with sweats: 9:30pm vomited layed down: 1am woke sweating shivering fever still 100 took a shover started extreme body aches with chest pain: drove myself to Stony Brook ED: labs ran covid swabbed still with all symptoms: chest xray preformed: released at 6am was told to monitor symptoms and if I can not keep anything down like water and or still with chest pain after 24hrs return to ED
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| 44 | 2021-02-22 | nausea |
I was given my 2nd dose of Covid-19 vaccine on 10 Feb 2021 at about 0800 am, I stayed at the facilit...
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I was given my 2nd dose of Covid-19 vaccine on 10 Feb 2021 at about 0800 am, I stayed at the facility for 15 minutes and did not have any issues at that time. My arm was a bit sore and I felt tired for a couple days following the 2nd vaccine. On 12 Feb early afternoon (around 1100am), I noticed I was dizzy and feeling a bit nauseated like I had motion sickness. I already had the following week off work, so I napped when I could. I have been tired as well. I have been experiencing waves of dizziness daily now since 12 Feb (today marks the 12th day). I spoke with my PCM's team at the Spokane VAMC and they recommended I try to take Meclizine at night to see if I improve. I was advised to have someone drive me to urgent care if my condition worsens where I lose consciousness, faint, or cannot stand up straight.
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| 44 | 2021-02-23 | diarrhea |
Enlarged painful lymph nodes on right side neck and body under arm. Hot arm, diarrhea, extreme fati...
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Enlarged painful lymph nodes on right side neck and body under arm. Hot arm, diarrhea, extreme fatigue, headache. My neck and underarm are still achy and enlarged. My body is still sore and I have not been able to continue with my daily activities. I have not felt like this since I had mono as a 19 year old. I have 5 children and have gone through natural childbirth 3 times. I?ve received all my vaccinations faithfully and have never in my life reacted this way. I am not getting the second dose until I have blood work done to see how my high my antibody levels are. I respect and am grateful for your work However I need to see data on my body?s reaction to even consider getting another dose.
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| 44 | 2021-02-24 | vomiting, nausea |
Had reaction with first dose. Given Benadryl 50 mg oral at 17:00 just prior to vaccine administratio...
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Had reaction with first dose. Given Benadryl 50 mg oral at 17:00 just prior to vaccine administration. Within 10 minutes of vaccine administration she developed scratchy throat, felt like lump in throat, then progressed to itching all over body, no visible rash, became nauseated and dizziness. Denied any SOB or tongue swelling. About an hour after vaccine given began to vomit. Patient then transported to ED for further evaluation and treatment. Admitted to ED at 18:25 where she received Decadron 10mg IV, Pepcid 20mg IV and Zofran 4mg IV. Vomiting resolved as well as chest tightness, dizziness, headache, throat itching resolved. She was dismissed from ED at 20:03.
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| 44 | 2021-02-25 | vomiting |
I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to ...
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I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to the Covid vaccine; coughing up mucus; severe body aches; This is a spontaneous report from a contactable consumer (patient). Information were received also from Pfizer-sponsored program COVAX US Support. A 44-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#EL9267), via an unspecified route of administration in the left arm on 09Feb2021 17:30 at single dose for COVID-19 immunisation. Medical history included asthma, iodine allergy. The patient previously took atropine and sulfur and experienced drug hypersensitivity. The patient was not pregnant. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast (MONTELUKAST), ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT), colecalciferol (VITAMIN D). The patient experienced dizziness, couldn't walk, vomiting, tongue swelled, allergic reaction to the covid vaccine, coughing up mucus and severe body aches on 10Feb2021 at 00:00 with outcome of recovering. The patient reported that about six hours after the vaccine, she woke up severely dizzy, she couldn't walk and was vomiting. Her husband called the paramedics and She was taken to the hospital. She was at the hospital for 6 hours. Her tongue swelled while she was at the hospital (as reported). The attending physician said that she was having an allergic reaction to the Covid vaccine. She was not been able to go to work this week. She had been coughing up mucus and had had severe body aches. The patient would like to have help paying for the medical bills she had incurred. Events resulted in Emergency room/department or urgent care. The patient received medications as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
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| 44 | 2021-02-27 | vomiting |
Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes ...
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Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes 10 minutes after injection Chest pain and tightness 15 minutes after injection Brain fog delayed movement thyroid meds left my system 20 minutes after injection
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| 44 | 2021-02-27 | difficulty swallowing, nausea |
First light dizziness increased to severe dizziness. Feeling the need to vomit No ability to swallo...
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First light dizziness increased to severe dizziness. Feeling the need to vomit No ability to swallow Shortness of breath Rapid heartbeat (130) Paramedics took vitals blood pressure and heart rate. I was asked to lay on gurney which I refused. I sat in chair. Paramedics monitored for 45 minutes until everything returned to normal. Walked to car by paramedics. Mom needed to drive home I was unable to.
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| 44 | 2021-02-28 | nausea, retching |
01.20.21-01.27.21: headache and fatigue daily 01.22.21: dizziness and right sided facial twitching a...
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01.20.21-01.27.21: headache and fatigue daily 01.22.21: dizziness and right sided facial twitching along the mandibular branch of the facial nerve. This lasted ~ 4 hours 01.26.21: fever 99.2, nausea & dry heaving, left sided ear and throat pain, coughing, body aches, fatigue. These symptoms lasted ~ 12 hours
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| 44 | 2021-02-28 | vomiting |
One minute after receiving the vaccine my face and tongue began to tingle. Then they began to swell....
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One minute after receiving the vaccine my face and tongue began to tingle. Then they began to swell. The swelling lasted for 4 hours. 16 hours after the vaccine I had a fever of 101 degrees Fahrenheit, chills, muscle aches, a headache, and I was vomiting. This lasted for 36 hours.
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| 44 | 2021-02-28 | abdominal discomfort, nausea |
Sat 5pm eyeballs began to hurt. The entire eyeball was painfully sore. At night I woke up with ton...
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Sat 5pm eyeballs began to hurt. The entire eyeball was painfully sore. At night I woke up with tongue that felt thick or swollen. Then the next am woke up with aches, headache, chills, hot (suspected fever but did not get up and check) tiredness. Spit up yellow fluid (thought it might be from GERD) and laided around all day. Did not eat as stomach felt nauseated. At 3 pm I ate half a sandwich and at 4 ate half a banana and drank some water and 1/4 of cup of sweet tea. By 6pm I was really sick to my stomach got up and threw up sandwich and banana. I thought I saw some blood but was not sure. I continued to throw up and it became all blood (bright red) mixed with water. This occured twice and then I called doctors office and the dr on call advised me to go to ER since urgent cares were closed. I went to ER about 8:30pm with continued headache, nausea, lightheadedness. I tried to tell ER dr that I was there mainly for throwing up blood. I sat in waiting room. ER dr saw me at 3am and gave me Zofran for nausea as i thought I was going to be sick and gave me EKG, Blood panel and Blood Pressure readings. Told me I was mildly dehydrated. My BP was higher than I think I have ever seen it.
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| 44 | 2021-02-28 | decreased appetite, abdominal pain upper, nausea |
Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the...
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Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the bath tub. Didn?t take temperature until 9:00am 100.9. Husband gave me Advil & Tylenol. Stomach ache/nausea came next, didn?t feel like eating. Very painful back ache shortly after that. Temperature kept fluctuating all day (due to Tylenol use). The next day (today 3-1-2021), I felt better, so I went to work. I noticed all day I getting the cold sweats. I was clammy most of the day, but didn?t feel tired. Took temperature after someone noticed I looked pale at work. My temp was 99.7. At around 4:30 I noticed my left armpit was hurting. Went home at 5:30 and relaxed. I told my husband my armpit was hurting around 10:30pm, I decided to Take my temp at 11:15pm and it was 97.6. I will see if the adverse side affects go away after today.
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| 44 | 2021-02-28 | nausea |
injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tyle...
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injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tylenol); feel febrile and woke up with the sweats at 2:am; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable nurse (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3249) intramuscularly in the right arm on 26Jan2021 (at the age of 44-years-old) at 11:00 as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took thimerosal on an unknown date for an unknown indication and experienced drug allergy. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) on 05Jan2021 at 10:30 intramuscularly in her right arm. On 27Jan2021 at 02:00 the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell. No treatment was provided for the events. Therapeutic measures were taken as a result of fever and included paracetamol. The clinical outcomes of injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell were unknown. It was also reported the patient was not COVID tested post-vaccination.
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| 44 | 2021-03-04 | nausea |
Fever, chills, joint pain, muscle pain, headache, nausea my symptoms started 10 hours after my 2nd d...
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Fever, chills, joint pain, muscle pain, headache, nausea my symptoms started 10 hours after my 2nd dose injection.
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| 44 | 2021-03-04 | abdominal discomfort |
Intestines froze up, can?t breathe normally and my tumor and abdomen has been inflamed. My spouse al...
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Intestines froze up, can?t breathe normally and my tumor and abdomen has been inflamed. My spouse also got a shot and has been projectile vomiting and has flu like symptoms. Both of us are lethargic.
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| 44 | 2021-03-04 | difficulty swallowing |
Patient received the Covid-19 vaccine. She reports symptoms of flushing, swollen feeling in throat w...
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Patient received the Covid-19 vaccine. She reports symptoms of flushing, swollen feeling in throat with some difficulty swallowing. No difficulty breathing, no wheezing, etc. Symptoms quickly lessened in intensity with first set of vitals. Injection was given at 1443. I have observed patient from immunization given through 1605. Treatment/intervention 1500: BP 138/90 Pulse 94 SPO2 98% Respirations 20 Diphenhydramine 25 mg given - patient requests to receive. 1502: BP 128/90 Pulse 100 SPO2 96% 1506: BP 126/88 Pulse 96 SPO2 99% Respirations 16 Patient tolerated 8 oz water, swallowing Without difficulty, still feels strange feeling in throat but much improved. 1510: Patient states she is feeling "much better" and has called spouse for ride home. 1525: 2nd dose of Benadryl 25 mg given. Patient is feeling much better, throat swelling sensation decreased, face is pink, not flushed, swallowing well and tolerated second 8 oz water. Instructed to contact physician regarding reaction today. Instructed to call 911 if any symptoms recur, difficulties breathing, etc. 1605: Escorted to husbands car, states feels "good."
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| 44 | 2021-03-04 | retching, vomiting |
fever, muscles, joint, bone pains (severe), Vomiting x 1 day, with continuous gagging and vomiting d...
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fever, muscles, joint, bone pains (severe), Vomiting x 1 day, with continuous gagging and vomiting daily since then, migraine
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| 44 | 2021-03-07 | nausea |
Extremely sore arm for 3 days Nauseous for 4 days Lymph nodes under left arm swollen and very tender...
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Extremely sore arm for 3 days Nauseous for 4 days Lymph nodes under left arm swollen and very tender for 5 days
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| 44 | 2021-03-07 | nausea, vomiting |
generalized aches and pains; fatigue; head fog; hot and cold flashes; Nausea; vomiting; insomnia; Si...
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generalized aches and pains; fatigue; head fog; hot and cold flashes; Nausea; vomiting; insomnia; Site pain persisted; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265 and expiry date: unknown), via an unspecified route of administration on the right arm, 04Feb2021 16:00 at a single dose for COVID-19 immunization. Medical history included HTN and Asthma. Patient was not pregnant at the time of administration. Concomitant medication included Olmesartan, bupropion hydrochloride (WELLBUTRIN), loratadine and vitamins. The patient previously took sulfur and morphine and experienced allergies. Events began with insomnia the night of injection on 04Feb2021 23:00. The following morning of 05Feb2021, patient woke with generalized aches and pains, fatigue, head fog, and hot & cold flashes. She had nausea and vomiting midday. Symptoms resolved by second day on 05Feb2021 but site pain persisted on Feb2021. TYLENOL and ibuprofen were given as treatments for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination.
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| 44 | 2021-03-09 | nausea |
Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid hea...
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Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid heart rate; nausea; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies, some environmental allergies, some heart issues specified as SVT, slight asthma, and lung damage. Prior to vaccination, the patient was diagnosed with COVID-19 on 26Dec2020 (also reported as possibly had COVID in Mar2020, however no tests were available; patient was told to quarantine). On 31Dec2020, COVID-19 test showed a positive result. The patient recovered on 09Jan2021, two weeks from onset of symptoms. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. On 21Jan2021 at 16:15, the patient experienced the following adverse events: flushed, over heated, rash/hives on chest, dry mouth, swollen tongue, rapid heart rate, nausea, headache, and weakness. The events resulted to emergency room visit and doctor office visit. The patient received two epi shots, allergy and anti-nausea medications as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.
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| 44 | 2021-03-10 | decreased appetite, diarrhea, nausea |
Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored ...
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Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored stools; Very faint/thought she was going to pass out; Eyes were watering; blotches on her neck and chest; tingly experience on her tongue and lips; Severely shaking; Overwhelming chills; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: E19266) via intramuscular at single dose on 20Feb2021 09:30 for COVID-19 immunization. The first dose was on 30Jan2021 in left arm. Medical history included splenectomy from Feb2017; pancreatic surgery from Feb2017, they removed her spleen as part of that; soy allergy; poultry allergy. Patient confirmed she had splenectomy. The surgery was sort of emergency based so knowing most likely they were taking her spleen out; she was given 4 vaccinations. In the hospital, she did break out in what appeared to be like a chicken pox type rash. The rash lasted a month and then it started to fade. She did not have any breathing sort of symptoms. The doctors did attribute the rash to one of the vaccinations, she was not clear on what vaccine caused the reaction. Ideally, she was supposed to have 2 weeks prior to the surgery so her body had time to reabsorb but she did not have that kind of time, but she had nothing internally going on. She confirmed she had no names, NDC, Lot number or expiration dates for the vaccines she received at that point in time. Having the splenectomy was the biggest thing. In the past, she did not have any allergies to medications, but did have allergies to soy and poultry. She did break out from certain food and her skin develops those blotches. She did have an extra work up in Feb2020, where they tested a bunch of food sensitivities and allergies, and nothing came back. This was right before COVID hit so she did not really follow back up after that, but she was tested for all major foods and household things and nothing came up. In her late 20's, she definitely tested for a soy allergy and allergy to poultry. She did check off yes, she had a reaction previously when she was filling out the form at the COVID-19 vaccine site knowing that she had this prior experience. She was held 30 minutes each time for that reason. Concomitant medication was none. Prior vaccinations (within 4 weeks) was no. On 20Feb2021, patient was very faint, thought she was going to pass out, eyes were watering, blotches on her neck and chest, tingly experience on her tongue and lips, severely shaking, overwhelming chills, extreme nausea. On an unspecified date, patient experienced headache, general weakness, in her legs especially, no energy, no appetite, chills that come and go, diarrhea and green colored stools. Patient received her second shot of Pfizer's vaccine on 20Feb2021. She had had symptoms ever since. She had a reaction on site at the vaccine center. She eventually had to go to the Emergency Room by ambulance. Her symptoms were still going on and tomorrow would mark a week since she received the second dose. The symptoms she experienced on site were different than what she was currently experiencing. She felt like she had a true reaction at the vaccine facility site. Within 6 minutes of receiving the second vaccine, she became very faint, her eyes were watering. She thought she was going to pass out for a bit. She was told she had blotches on her neck and chest. She had a tingly experience on her tongue and lips. She was severely shaking and had overwhelming chills. She stated this happened for a couple of hours. Basically, there were 3 waves of these symptoms kind of happening. The third wave happened probably a couple hours after receiving the vaccine. At that point, she had been given two pills of diphenhydramine hydrochloride (BENADRYL), taken orally. With the third wave, she thought she was going to pass out, which she thought multiple times before, but then with this particular wave, she experienced extreme nausea which was kind of a new symptom. The doctor on site said to the EMT that he wanted her to go to the Emergency Room. Patient confirmed she was taken to the ER via ambulance the day she received the vaccine, 20Feb2021. She was never admitted into the hospital; she was only seen in the Emergency Room for a couple of hours. She was given IV fluids, she had blood work done. She didn't have a copy of her labs but she was told they were okay. She was injected with diphenhydramine hydrochloride (BENADRYL) via IV before she was released. A lot more symptoms came after she was released from the hospital (ER). She came home and she had just a crazy headache that she really woke up with every single day until this morning. She had been taking a lot of caffeine/paracetamol (EXCEDRIN, Lot#: H044G, Expiry Date: Jun2022) for her headaches. She experienced extreme weakness, nausea. She clarified she had weakness in her legs. She had this exhaustion, and she felt this general weakness sort of in her legs especially. She was still taking stuff for a headache, and she was taking nausea pills. She had been out of work all week. She had no energy, no appetite really. She had chills that come and go. She had diarrhea. She clarified she had more diarrhea in the beginning days after receiving the vaccine, but it was always been a green colored stool as well. The ER called and checked in and were very surprised she had been having the symptoms still so severely. They wanted her to go get an actual COVID test. She went to the Urgent Care to get COVID tested on 23Feb2021 and had a rapid and PCR test. The rapid test came back negative. She had not received the results for the PCR test yet. She was taking diphenhydramine hydrochloride but she stopped taking that. The hospital directed her stop taking the diphenhydramine hydrochloride earlier in the week. She clarified she was taking a generic version (Lot#: P113966, Expiry Date: Feb2021), coated mini tablets. She clarified the nausea pills she had been taking was the generic for ZOFRAN, ondansetron 4 mg tablet, by mouth, every 8 hours. She confirmed this product was dispensed in a pharmacy bottle with no NDC, Lot number or expiry date on it. She clarified she also had been taking the generic version of TYLENOL EXTRA STRENGTH, it was the Up and Up Brand acetaminophen (Lot#: P122699, Expiry Date: Nov2022) gel caps, 500mg. COVID-19 rapid test was negative on 23Feb2021; COVID-19 PCR test on 23Feb2021 was unknown results. Patient asked if there was a hotline she can call or an information number where she can talk to somebody about her symptoms. She also reported this to her doctor but the doctor made it clear since it was a private practice, they had limited information. The doctor did take down similar information, she just did not know if there was any further information or a hotline she could call. The outcome of events was unknown.
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| 44 | 2021-03-14 | vomiting |
Chills; fever; body aches; dull headache; vomiting; This is a spontaneous report from a contactable ...
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Chills; fever; body aches; dull headache; vomiting; This is a spontaneous report from a contactable consumer (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL926lt) via an unspecified route of administration in the left arm on 07Feb2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunization. Medical history included ulcerative colitis from an unknown date and unknown if ongoing. The patient did not have allergies to medications, foods or other products and was not diagnosed with COVID-19 prior to vaccination. The patient had no concomitant medications. The patient previously received infliximab (REMICADE) infusions from an unknown date for ulcerative colitis; and received the first dose of BNT162B2 (lot number El3247) in the left arm on 17Jan2021 at 12:00 (at the age of 44-years-old) for COVID-19 immunization. The patient did not receive any other vaccines within the 4 weeks prior to the COVID vaccine. On 08Feb2021 at 00:15 the patient experienced chills, fever, body aches, dull headache, and vomiting. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The events of chills, fever, body aches, dull headache, and vomiting were recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.
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| 44 | 2021-03-17 | nausea |
Patient stated that she almost immediately felt nausea after the injection appx 3:15, was able to am...
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Patient stated that she almost immediately felt nausea after the injection appx 3:15, was able to ambulate to observation on her own and then signaled staff for help, felt hot, felt dizzy, felt nausea, staff immediately assisted to chair, RN @ side; inquired re food; had lunch; sips of beverage w sugar given able to eat cracker. She stated she felt better, was upright in her chair, no SOB, no complaints of swelling throat, itchy etc. After some initial sips of liquid, still feeling dizzy lowered to floor by staff w wedge cushion and legs and feet elevated above heart per protocol b/p 140/96 pulse 86. Stated she had been anxious re injection, but denied ever having this experience after injection. Additional information for Item 18: Reviewed the POD form questions again with her, denied any issues. She then stated she was feeling much better again, her warm feelings were going away from ice in a glove that we had used from her initial dizzy, warm/hot feeling. Around 3:30 she felt nausea again, so we sat her up and gave her a bucket to use to vomit if needed. She was unable to vomit. She wanted to sit up on floor. We sat with her and she sipped on clear beverage. She began to get cold. We put her legs back up took b/p 140/91 pulse 86. No change. We called nursing DON for District to make her aware and by that time patient experiencing chills. We called her husband to be on his way to drive her home after 30 minutes @ 3:45. She continued to tell us she felt better for a few minutes only to then tell us she was feeling nausea again. Rolled her to left side, helped her to prop us to vomit but she was unable to vomit anything. B/p readings 147/91, 150/90, 140/87,150/88She desired to sit upright again. So on floor with nurse holding and b/p cuff on sat her up to try to vomit, unable to do so. Lowered back to floor with legs upright where she remained local Paramedic on site and he came to assist, a portable recliner that allowed for legs to be elevated above heart was set up. Patient felt that she could transfer with paramedic and staff help and passed out while attempting briefly, chilling when she was alert, then passing out again; 911 was called and arrived by 3:55, patient and husband initially wanted to take patient home after hearing patient state she felt better once paramedics had evaluated her. However in front of husband, patient again passed out, and after she was conscious stated she could not feel her arms. and when he observed this he agreed it was best for her to be evaluated and then was transported to ER. Per phone conversation this morning, at 10:41 husband stating that patient still not able to stand without passing out on her own and they were continuing to evaluate her. No additional medication given on site at Mass vaccine site.
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| 44 | 2021-03-22 | diarrhea, nausea |
I have Epstein barre and it feels like it has been reactivated.; waves of dizziness; fatigue; nausea...
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I have Epstein barre and it feels like it has been reactivated.; waves of dizziness; fatigue; nausea; diarrhea; headache; I have been having vivid nightmares during this time as well; metallic taste; This is a spontaneous report from a contactable consumer (patient). The 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 09:45 AM (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included Chronic fatigue syndrome, Epstein barre. The patient was not pregnant. No other vaccine in four week. No covid prior vaccination. The patient did receive other medications in two weeks. The patient experienced i have epstein barre and it feels like it has been reactivated, waves of dizziness, fatigue, nausea, diarrhea, headache, i have been having vivid nightmares during this time as well, metallic taste on 24Feb2021 14:00. Reported as: I have Epstein barre and it feels like it has been reactivated. I have waves of dizziness , fatigue, nausea, diarrhea, headache and metallic taste. I have been having vivid nightmares during this time as well. I developed a metallic taste in my mouth. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.The patient had covid tested post vaccination via Nasal Swab on 03Mar2021 and was negative. It's unknown if the patient received treatment. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.
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| 44 | 2021-03-23 | nausea |
Dizzy; Lost all the strength in her arms and legs; Passed out; Nauseous; She dropped to her left whe...
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Dizzy; Lost all the strength in her arms and legs; Passed out; Nauseous; She dropped to her left when she passed out and fell in shower; Ear completely clogged up only on the left side; Headache; Tired; Soreness on my arm; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 07Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included underactive thyroid. Concomitant medication included unspecified thyroid medication. The patient was asking if her symptoms were normal following the vaccination. She got the second dose of the COVID vaccine yesterday, 07Mar2021 at around 11:00 (also reported as 10:00 to 10: 15 or 10:30). Throughout the day, she was fine and mentioned that she had soreness on her arm later. At around 22:00, she was driving home and started feeling a slight headache and reported that she didn't take anything. She was tired, so when she got home, the patient fell asleep. She woke up and did feel a slight headache and couldn't sleep on her left arm because it was killing her, but it was fine. At 5:30 this morning (08Mar2021), the headache was still there. She then stood and sat up, took her thyroid pill because she has an underactive thyroid and was on the highest dose of thyroid replacement. The patient stated that the events happened so fast, as soon as she got into the shower. She got out of bed and started walking, grabbed her stuff to shower and started feeling that her headache was building up more than it had all morning so far. She thought maybe it was just because she had just physically gotten up and started walking. She got into the shower, and for about 2-3 minutes into getting into the shower, she remembered she had started putting shampoo into her hands; grabbing the shampoo bottle; but she suddenly got so nauseous and the headache that came on was extreme. She did not have a lot of time to react. She thought she would throw up in the shower, she had no time to get out of the shower to the toilet to throw up; she suddenly felt dizzy, passed out in the shower and fell to her left side on the floor. All she could remember before she passed out was that she had the shampoo bottle in her hands and she said out loud, she heard herself say "What is happening to me". Then she lost all the strength in her arms and legs. She remembered for a split second she tried to hold on, she dropped the shampoo bottle on the floor and grabbed the rail or edge of the shower and tried to hold on because she felt herself when she went down. Her left ear was completely clogged up only on the left side. When she passed out, thankfully she thought by trying to hold on to the rail or edge of the shower that she kind of eased her fall down, so she did not fall hard or hit her head. She did not know if she passed out for seconds or minutes because she has no idea exactly when she went into the shower, maybe around 05:45; but when she woke up she realized she was on the floor, she was not flat on the floor but on her knees, having fallen to the left side with her head off to the side on the shower wall; the glass door to her shower was wide open and all the water was coming out of the shower; it scared her when she woke up. The outcome of the event passed out was recovered on 08Mar2021, not recovered for headache, and unknown for all other events. Information on the lot/batch number has been requested.
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| 44 | 2021-03-23 | nausea |
She had previous reaction to Paclitaxel and was given vaccine in high risk COVID vaccine allergy cli...
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She had previous reaction to Paclitaxel and was given vaccine in high risk COVID vaccine allergy clinic. We pretreated her with cetirizine but did not test her to PEG. She developed significant distress, nausea and cough 2-3 minutes after receiving the vaccine. There was no hypotension, wheezing noted. She was treated promptly with epinephrine 0.3 mg. Within five minutes she started to feel better aside from adverse effects from Epi. Left arm and shoulder pain. No significant shortness of breath. She had a large amount of clothing on so were unable to fully see skin but no visible rash. She was transferred to the emergency department.
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| 44 | 2021-03-24 | nausea, difficulty swallowing |
Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous...
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Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous/shakes; Immediately felt tingling, got shaky and nauseous; hard time swallowing and couldn't breathe right; hard time swallowing and couldn't breathe right; Waves of heart racing; her left leg and arm, her right leg had pins and needles and loss of feeling; wheezing; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Mar2021 09:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. Patient experienced immediately felt tingling, got shaky and nauseous. It was coming in waves. she was having a hard time swallowing and couldn't breathe right. She was in the holding. For 15 minutes and she received dismissed annoyed no help from an EMT working in the waiting area for effects. She left. Got a mile down the road and called 911 she was unable to get enough oxygen in. The ambulance arrived and immediately gave her epinephrine, Benadryl, and a breathing treatment along with other medications. She arrived at the hospital and she was doing better and they kept her for observation. She was feeling fine, left with an Epipen and prednisone. The next day (18Mar2021) she felt great until the night time she started wheezing again. She woke up on Friday (19Mar2021). Having shakes and hard time breathing and waves of heart racing. she made a doctor's appointment and received a inhaler. Her symptoms were not getting better and she took Benadryl which helped. By that night her left leg and arm, her right leg had pins and needles and loss of feeling. Treatment included Epinephrine, Benadryl, Prednisone, Albuterol. No COVID tested post vaccination. Events immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right required clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness. Outcome of immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right was recovering.
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| 44 | 2021-03-25 | difficulty swallowing |
Dizziness; numb tongue; difficulty swallowing; difficulty breathing; inability to move arms and legs...
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Dizziness; numb tongue; difficulty swallowing; difficulty breathing; inability to move arms and legs; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6199 and expiration date unknown), via an unspecified route of administration in the left arm on 09Mar2021 at 15:00 as a single dose for COVID-19 immunization. Medical history included depression, pre-diabetes and known allergies: bee stings. Concomitant medications included loratadine (LORATADINE), metformin (METFORMIN), paroxetine (PAROXETINE), and bupropion hydrochloride (WELLBUTRIN), and "Mul". The patient had no other vaccine in four weeks. On 09Mar2021 at 15:15, The patient experienced dizziness, numb tongue, difficulty swallowing, difficulty breathing, and inability to move arms and legs. The patient had no COVID prior vaccination and had not tested post vaccination. Therapeutic measures were taken as a result of the events which included Epinephrine, ER treatment, and Prednisone. The outcome of the events was resolving. The events resulted in: Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event).
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| 44 | 2021-03-26 | difficulty swallowing |
She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swel...
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She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swelling and vocal changes with wheezing within 15 minutes of receiving the vaccine. She was treated with benadryl and albuterol and sent home after improvement. After going home, continued to have some lip/throat swelling. She then presented to local hospital with worsened symptoms, treated with benadryl and steroids, given a script for prednisone, and sent home. She did not fill the prednisone script initially, but had some prednisone (unknown strength) at home and took a pill. The following morning (3/26), she continued to have throat and lip swelling and began to develop some dyspnea. Due to these worsening symptoms, she came to ED. She received a total of 5 doses of IM epinephrine (1734, 1938, 2010, 2320, 0017) along with IV pepcid and IV solumedrol for persistent subjective throat swelling, dyspnea, and difficulty tolerating secretions. She was admitted to the ICU for close monitoring of symptoms and consideration of an epinephrine drip, but did NOT require this. In the morning of 3/27, she noted substantial improvement in symptoms of tongue/lip swelling, improved wheezing, dyspnea, and dysphagia. Still with some mild hoarseness that she attributes to cough, also improving.
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| 44 | 2021-03-29 | abdominal pain upper, nausea, vomiting |
I had an asthma attack at work. I felt nausea. I checked into a Medical Center ER when I was havin...
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I had an asthma attack at work. I felt nausea. I checked into a Medical Center ER when I was having the attack and I couldn't control my breathing body aches - and they gave me anti-nausea medicine. A few days after that I was non stop throwing up - I couldn't get out of bed. I was still having intermittent vomiting - about once a week - and I'd have to take off work. This kept happening up until about a month ago (with the vomiting). It was horrible. I had headaches, too - they weren't major but were bothersome - I had them for about three weeks and then they went away. A couple of weeks later - I was still throwing up and I went to ER - but I don't remember the date of second visit - they gave me IV and Zofran. I had stomach pain from the vomiting. I was admitted into hospital last week - the 18th and was discharged the next evening. I was using inhaler every day for two times a day. They dosed me with a lot of antibiotics - IV antibiotics and also Steroids - Zumatrol and they sent me home with doxycycline HIC 100 mg and those were for 10 days; twice a day; and I haven't been needing my inhaler since last Friday.
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| 44 | 2021-04-09 | decreased appetite |
About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went comple...
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About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went completely numb and tingling. Scalp tingling and numb. Felt like circulation was cut off. Severe Shortness of breath. Extreme feeling of adrenaline. The next day on March 14th, had extreme vaginal bleeding on day 14 of cycle. Bled for another 7 days which led to extreme anemia. The shortness of breath is every day since the first dose. Heart palpitations (heart rate went up to 190!). After the second dose on 4/03, all symptoms got worst. Left leg went completely numb the same day which I went to the emergency room for. The neurological tingling and numbness was spreading to my whole body. Arms, legs, face, ears, scalp, inside my head. I was worried for a heart attack since all of my symptoms of left arm and shoulder pain and numbness etc. I was released from the emergency room 12 hours later. I continued to have severe symptoms. The shortness of breath was so bad that I didn't sleep for 2 nights straight because my oxygen would drop. I also had severe insomnia and no appetite and lost 5 pounds in 1 week. Major adrenaline feeling. I went back to the emergency room 2 more times this week to check out my heart and lungs. All of my doctors recommended ER since they couldn't help me. My neurologist said he is getting lots of these symptoms from people post vaccine. My shortness of breath and elevated heart rate and numbness and tingling are still here and I can barely go up and down stairs without being out of breath and having a 130-140 heart rate and super low blood pressure and night sweats. It is awful.
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| 44 | 2021-04-09 | nausea |
I fainted; I was disoriented and the room was spinning.; I was disoriented and the room was spinning...
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I fainted; I was disoriented and the room was spinning.; I was disoriented and the room was spinning.; extremely nauseated; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 24Mar2021 at single dose in left arm for COVID-19 immunization. Medical history included Cancer. No known allergies. No covid prior vaccination. Patient was not pregnant at time of vaccination. Concomitant medication in two weeks included letrozole. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. It was reported that when patient woke up in the middle of the night. Patient was disoriented and the room was spinning. patient fainted and then was extremely nauseated all on 25Mar2021 02:00 AM. No treatment for adverse events. No covid tested post vaccination. The outcome of events was recovering. Information about lot/batch number has been requested.
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| 44 | 2021-04-09 | vomiting, nausea |
nausea; vomiting; chest pain; myocarditis; thrombocytopenia; This is a Literature-spontaneous report...
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nausea; vomiting; chest pain; myocarditis; thrombocytopenia; This is a Literature-spontaneous report 2021, 1-4; entitled Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination. A 44-year-old woman was hospitalized for nausea, vomiting and chest pain on the day that she received the Pfizer vaccine (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number unknown) at single dose (at 44-year-old) for COVID-19 immunization. Her laboratory values included a platelet count of 85 x 109/L and a peak troponin level of 4 ng/mL (normal < = 0.04 ng/mL). The patient was diagnosed with myocarditis but did not require treatment for thrombocytopenia. Her platelets were 61 x 109/L on discharge, but subsequent platelet counts were not reported. The outcome of the events was unknown. No follow-up attempts are needed. Information on Lot/batch number cannot be obtained.; Sender's Comments: The causal association cannot be excluded between the reported events and BNT162B2 vaccine use. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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| 44 | 2021-04-12 | nausea, vomiting |
Was not instructed to wait after shot so I went to my car. Drove for a couple of hours. Got out of c...
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Was not instructed to wait after shot so I went to my car. Drove for a couple of hours. Got out of car, walked forward and passed out with a seizure then throwing up when I came to. Received concussion. Taken to ER and admitted for 5 days. Still experiencing vertigo and nausea
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| 44 | 2021-04-15 | retching, nausea |
Extreme dizziness - like I was drunk all of the sudden - Severe Tiredness, bad Headache, Muscle pain...
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Extreme dizziness - like I was drunk all of the sudden - Severe Tiredness, bad Headache, Muscle pain, Chills, Fever 100 - 100.6, Nausea (dry heaving). Missed two days of work. I am going to work today but still feel like crap. I had the same reaction, but less to the first dose. 3/23/21
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| 44 | 2021-04-20 | nausea, diarrhea |
At 2am, 12 hours after shot woke up with severe chills and couldn?t get out of bed. Took Advil a and...
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At 2am, 12 hours after shot woke up with severe chills and couldn?t get out of bed. Took Advil a and Tylenol to sleep. Woke up next morning and took Tylenol at 8am so I could try to have a normal day. Held off on medicine but started to feel exhausted and got hot / shaking chills again at 3pm and could not get warm . Took a nap to try to avoid medication but then took Advil/Tylenol again at 5pm because my fever reached 103 and I was too uncomfortable. Fever broke an hour later and I was able to sleep all night. Felt 90% better in morning and pretty normal by 48 hours after shot though continued to have fatigue and some periodic nausea into following day and one instance of diarrhea. Also arm was sore.
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| 44 | 2021-04-20 | nausea, vomiting, diarrhea |
Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Int...
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Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Intense headache, neck, facial and cranial pain; Extreme vertigo within 1 hour; loose stool; Nausea; vomiting; Swollen; itchy hives; itchy hives; Swollen left eye; This is a spontaneous report from a contactable HCP and a consumer (the patient). A 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Batch/Lot Number: EW0150) as single dose for covid-19 immunisation . Medical history included migraine, demyelination , post-traumatic stress disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced immediate left side (injection side) headache. on 03Apr2021 11:45 with outcome of not recovered , intense headache, neck, facial and cranial pain on 03Apr2021 11:45 with outcome of not recovered , extreme vertigo within 1 hour on 03Apr2021 11:45 with outcome of not recovered , loose stool on 03Apr2021 11:45 with outcome of not recovered , nausea on 03Apr2021 11:45 with outcome of not recovered , vomiting on 03Apr2021 11:45 with outcome of not recovered , swollen on 03Apr2021 11:45 with outcome of not recovered , itchy hives on 03Apr2021 11:45 with outcome of not recovered , swollen left eye on 03Apr2021 11:45 with outcome of not recovered. All the reported events were considered Important Medical Events. Course of the event: Immediate left side (injection side) headache. Spread to entire head within 30 minutes. Intense headache, neck, facial and cranial pain persists at hour 53. Extreme vertigo within 1 hour, persisting now at hour 53. Nausea, vomiting and loose stool within 6 hours. Vomiting ceased at 48 hours post 1st shot vaccination. Nausea and diarrhea persists at hour 53. Swollen, itchy hives, injection side within 40 hours, spread to neck and face. Swollen left eye, within 24 hours, waning at hour 53. No follow-up attempts are needed. No further information is expected.
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| 44 | 2021-04-24 | vomiting, nausea |
causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eye...
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causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; Nausea; repeated vomiting; This is a spontaneous report from a contactable consumer (reporting for herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 10:15 (Batch/Lot Number: ER 8737) as single dose for COVID-19 immunization. Medical history included drug amoxillin allergy. Concomitant medication included ibuprofen, simeticone (GAS X), cimetidine (TAGAMET [CIMETIDINE]) and colecalciferol (VITAMIN D [COLECALCIFEROL]), all taken for an unspecified indication, start and stop date were not reported. On 07Apr2021 at 23:00, the patient experienced causing burst blood vessels in face, eyes, nose and throat, nausea and repeated vomiting. The outcome of the events was recovering. The patient did not had COVID prior to vaccination and did not tested positive post vaccination. No follow-up attempts are possible. No information is expected.
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| 44 | 2021-04-24 | diarrhea |
her husband tested positive on 29MAR 2021 and she was direct exposed; Diarrhea; fluid in ears; teste...
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her husband tested positive on 29MAR 2021 and she was direct exposed; Diarrhea; fluid in ears; tested positive for Covid; tested positive for Covid; runny nose and sneezing; runny nose and sneezing; itchy ears and itchy throat; itchy ears and itchy throat; trouble breathing at night; This is a spontaneous report received from a contactable consumer (patient). A 45-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP3302) via an unspecified route of administration in left arm on 13Jan2021 at around 14:00-15:00 as single dose for COVID-19 immunization. Patient medical history included high blood pressure from 6-7 years ago and still ongoing. Concomitant medications were not reported. Patient received historical vaccination as first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), formulation: Solution for injection, Lot number: EH9899, via an unspecified route of administration in left arm on 23Dec2020 10:30 AM at single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. on 3Apr2021, she started having allergy symptoms like a runny nose and sneezing, itchy ears and itchy throat and had trouble breathing at night with clinical outcome of not recovered. She states that the doctor told her she had fluid in both of her ears on 5Apr2021 with outcome of event not recovered. she has diarrhea on 06Apr2021, with outcome of event not recovered. She reported that not even two months later, she has tested positive for COVID-19 on 05APR2021. She states that her husband tested positive on 29MAR2021 and she was direct exposed (exposure to SARS-COV-2) due to work she had to quarantine for 14 days, states her daughter tested positive two days after her husband, states neither of them had the vaccine. The patient did not receive any treatment for the events. The clinical outcomes of event not recovered. No follow-up attempts are possible. No further information is expected.
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| 45 | 2021-01-02 | nausea | Dizziness and Weakness, Headache, Aches, Cold feeling, Nausea, generally feeling unwell. |
| 45 | 2021-01-02 | diarrhea, vomiting |
Severe vertigo began at 3:00 PM on 12/31/2020. Vomiting lasting approx. 9 hours (8 episodes). Unable...
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Severe vertigo began at 3:00 PM on 12/31/2020. Vomiting lasting approx. 9 hours (8 episodes). Unable to open eyes due to vertigo, vasovagal upon standing lasting until approx. 3:00 pm 1/2/2021. Diarrhea began approx. 8:00 pm 1/1/2021 with episodes each time after trying to eat 4 episodes. Headache lasted 3 days. Today on 1/3/2021 I have been able to keep down soup. Eyes feel tired, minimal vertigo upon moving head. No further diarrhea, vomiting.
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| 45 | 2021-01-03 | diarrhea |
After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm a...
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After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm and leg for 20 minutes but neck and face numbness continued 12/25-12/27. Continued with facial numbness on 12/26. Called Occupational Health on 12/28 and stated that she had thigh numbness, no other Covid symptoms. Sent for testing and was negative. On follow up on 12/29, had fatigue, diarrhea and weakness, and on 1/1 still had thigh numbness and extreme fatigue, no diarrhea. By 1/3/21, had fingertip numbness on left hand, pain on her left arm and chest pressure and burning. Went to ER on 1/3 where she had a full workup for myelitis, MRI, C spine, T spine and brain, CBC, CMP, ESR. Treated with toradol and prednisone in ER and discharged. Currently on 1/4 improved muscle weakness but ongoing fatigue taking four day course of prednisone to follow up with PCP. A second dose of the vaccine scheduled on 1/11/21 will be on hold until PCP clearance. Current diagnosis decompensation of raynauds disease due to vaccine reaction.
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| 45 | 2021-01-04 | diarrhea |
Immediately after shot for 20 minutes was tasting metallic taste and tingling in right pinky and rin...
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Immediately after shot for 20 minutes was tasting metallic taste and tingling in right pinky and ring finger. Around 11 pm started having metallic taste and cannot get rid of it. Woke up in middle of the night having diarrhea which still having symptoms this morning.
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| 45 | 2021-01-04 | diarrhea |
Immediately upon receiving vaccination had metallic taste and tingling in right hand pinky and ring ...
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Immediately upon receiving vaccination had metallic taste and tingling in right hand pinky and ring finger. It went away in 20 plus minutes. Around 11 pm started having metallic taste again and woke up with diarrhea in the middle of the night. Symptoms have not subsided.
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| 45 | 2021-01-04 | nausea |
dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainde...
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dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainder of day; This is a spontaneous report from a contactable nurse reporting for herself. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 14:00 at a single dose for COVID 19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. There was no other vaccination administered in the 4 weeks prior to COVID-19 vaccination. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. There were no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported; the patient did receive other medications within 2 weeks prior to COVID-19 vaccination.The patient experienced dizziness and lightheaded, noticed about 30 minutes after vaccine. Vision slightly blurred. BP elevated to 144/96. Slight nausea for remainder of day. The events occurred on 23Dec2020 at 14:45 pm. No treatment was received for the events. The patient recovered from the events dizziness, lightheaded, vision slightly blurred, BP elevated to 144/96, and slight nausea on an unknown date in Dec2020. The patient was not COVID-tested post vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 45 | 2021-01-05 | diarrhea, nausea, vomiting, abdominal pain | Coughing, abdominal pain, nausea, vomiting, diarrhea, headache, fatigue |
| 45 | 2021-01-05 | decreased appetite |
I?m not sure if it was related to the vaccine but on day after shot I had loss of appetite. Day 2 af...
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I?m not sure if it was related to the vaccine but on day after shot I had loss of appetite. Day 2 after shot I feel like I can?t get enough to eat. I?m not sure if this has any relation to that though
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| 45 | 2021-01-05 | diarrhea | diarrhea, fatigue |
| 45 | 2021-01-05 | nausea |
next day with headache, nausea, dizziness, tachycardia up to 170 for about 30 minutes. symptoms star...
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next day with headache, nausea, dizziness, tachycardia up to 170 for about 30 minutes. symptoms started the morning after the vaccine about 24 hours later and then resolved within that next day.
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| 45 | 2021-01-06 | nausea |
At approximately 8 hours post vaccine I began to have Sudden onset bilateral joint pain mostly in my...
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At approximately 8 hours post vaccine I began to have Sudden onset bilateral joint pain mostly in my elbows but knees and hips as well. Then my neck started really hurting. I got a headache. Nausea and powerful chills that made my whole body violently shake. My core temperature Dropped to below 96, high 95s. Over a period of two hours I have stabilized my body temperature, the shaking has stopped. However the headache and muscle aches persist. No respiratory symptoms have developed. I feel as if I am recovering, over a period of about four hours.
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| 45 | 2021-01-06 | nausea |
Woke up in night sweats, nausea, severe headache with neck and back pain. right shoulder pain and ti...
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Woke up in night sweats, nausea, severe headache with neck and back pain. right shoulder pain and tingling right hand.
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| 45 | 2021-01-06 | vomiting | around 1500 Vomited x 1; HTN 190's/ 116-118; flush cheeks bilaterally; dizzy; weak; |
| 45 | 2021-01-06 | nausea |
nausea, hot flashes were noted, pt BP 162/98; Spo2 98%; HR 69. Pt given water and waited for extende...
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nausea, hot flashes were noted, pt BP 162/98; Spo2 98%; HR 69. Pt given water and waited for extended period. Pt stated she felt better and was able to ambulate independently. A/O x4
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| 45 | 2021-01-07 | nausea |
06 Jan 2021 @0810: Patient transported to ED following near syncopal episode at desk. Reported dizz...
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06 Jan 2021 @0810: Patient transported to ED following near syncopal episode at desk. Reported dizziness/lightheaded, intermittent nausea, and heart beating hard. Patient received vaccine at 0645 hours. Provided IV fluids.
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| 45 | 2021-01-07 | nausea |
After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by ...
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After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by a metallic taste. Elevated BP noted. Pt denies SOB and is without rash or angioedema. Pt brough to emergency dept where she reported feeling flushed, nausea, and headache. Given Zofran 4mg ODT and Tylenol 650 mg po. Pt d/c after 2 hours and advised to f/u w/ PCP as needed.
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| 45 | 2021-01-07 | nausea, vomiting | Chills, fever 101.2 (oral), headache, nausea, vomiting, body aches. |
| 45 | 2021-01-07 | nausea | Chills, fever, body aches, joint pain, painful lymph nodes in armpit, headache, nausea |
| 45 | 2021-01-07 | diarrhea |
Diarrhea; Headache; Arm soreness; This is a spontaneous report from a contactable nurse. This nurse ...
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Diarrhea; Headache; Arm soreness; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 3rd of 6 reports. A 45-year-old female patient received a single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) on 29Dec2020 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination, on 29Dec2020, the patient had arm soreness and it lasted a few hours. The patient took Tylenol and was fine. She also developed diarrhea and headache, and her symptoms hit her all of a sudden late afternoon on 04Jan2021. No treatment was received. She woke up in the morning of 05Jan2021 and it was all gone. She had a COVID test on 05Jan2021 and it was negative. The patient recovered from the arm soreness on 29Dec2020 and recovered from diarrhea and vomiting on 05Jan2021. The events were considered related to the vaccine. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
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| 45 | 2021-01-07 | abdominal pain, nausea |
Fatigue, fever 100.7, moderate headache, chills, muscle ache, joint pain, restlessness, fatigue, woo...
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Fatigue, fever 100.7, moderate headache, chills, muscle ache, joint pain, restlessness, fatigue, wooziness, mild nausea, mild abdominal pain. No asthma symptoms.
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| 45 | 2021-01-07 | diarrhea | Headache, Diarrhea with cramping |
| 45 | 2021-01-07 | decreased appetite, nausea, vomiting |
Headache, Myalgia, NauseaVomiting, lethargy; injection site soreness, loss of appetite Narrative: V...
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Headache, Myalgia, NauseaVomiting, lethargy; injection site soreness, loss of appetite Narrative: Vaccine 12/17 @6:00 pm. On 12/18/2020 - woke up with a headache and "tight" muscles. Progressively that day she felt lethargic. She also had soreness in her arm at the site of the vaccine. Within 24 hours she developed nausea and lost her appetite. She took alleve and went back to sleep. 12/20 - slept all day. 12/21 - woke up feeling much better with a mild headache. 12/22 felt back to normal.
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| 45 | 2021-01-07 | diarrhea |
I started having flushing within a minute of receiving vaccine next I noticed I had heart palpitati...
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I started having flushing within a minute of receiving vaccine next I noticed I had heart palpitations I was told my skin was clammy then I had another episode I was taken to ER and decardron was given. I was observed in ER for few hours . Since that day I have heart palpitations every day along with chest pain sometimes I am not able to wean off steroids I also had diarrhea on 1/3 that lasted few days . These side effects are very scary every day heart palpitations I feel my heart would stop
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| 45 | 2021-01-07 | nausea |
PT HAD A VASOVAGAL SYNCOPE EPISODE: ( SWEATING, NAUSEA, AND BLOOD PRESSURE DROPPING). PT WAS LAYED ...
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PT HAD A VASOVAGAL SYNCOPE EPISODE: ( SWEATING, NAUSEA, AND BLOOD PRESSURE DROPPING). PT WAS LAYED ON THE FLOOR IN A SUSPINE POSITIION WITH FEET ELEVATED. PT WAS PLACED ON A BLOOD PRESSURE MONITORING MACHINE. COLD COMPRESSIONS WERE APPLIED TO THE PATIENT'S BODY. PT WAS GIVEN A FEW CRACKERS AND SODA TO INCREASE BLOOD SUGAR. WITHIN MINUTES THE PT BLOOD PRESSURE BEGAN TO RISE AND PT FELT FINE. PT WANTED TO DRIVE HOME AND WAS ADVISED NOT TO DRIVE. PT CALLED FOR HER PARENTS TO COME AND PICK HER UP.
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| 45 | 2021-01-07 | nausea |
Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started...
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Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started to have lower chest (near the lower ribs) pain 9/10 pain and she was diaphoretic. We called 911 as we were concerned about an MI. She was transported via EMS to the hospital. They ran various tests and determined it wasn't cardiac or lung issues and was likely side effects from the COVID vaccine. On 1/8/21, Patient reports that she feels dizzy and is "itching all over." She took antihistamine and that helped the itching symptom.
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| 45 | 2021-01-07 | nausea | chills in evening after vaccination, chills next day in AM then nausea and body aches, temp 102. |
| 45 | 2021-01-07 | nausea |
typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting...
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typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting so sore I couldn't lift it; Within a few hrs I lost the ability to move it at all for a few hrs; overwhelmed with fatigue; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; nauseous; dizzy; No fever but I felt hot & flushed.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ek9231), via an unspecified route of administration on the right arm on 31Dec2020 09:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included lupus.The patient also had allergies to penicillin (PCN). It was also mentioned that the patient COVID twice (Mar2020 until 2020&Nov2020 until 2020). Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and bupropion hydrochloride (WELLBUTRIN). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient reported that she had a very slight reaction after administration & took diphenhydramine (BENADRYL). She described that approximately at the 11-hour mark (31Dec2020 20:00), her arm was getting so sore and she couldn't lift it. Within a few hours, she lost the ability to move it at all. Also, she was getting overwhelmed with fatigue & she had a feeling that can best be described as the feeling of death entering my bones. Every bone hurt and her ribs were so sore she couldn't take deep breaths. The patient would wake up crying in pain & her pain tolerance was very high. She felt nauseous & dizzy and was the worst night of her life. She took acetaminophen (APAP) 1000mg & meloxicam 15mg that night with no relief. She narrated that she had COVID twice (Mar & Nov) & that night that she experienced; she would rather have COVID 1000 more times than ever have this pain she was in. It was also mentioned that she had no fever, but she felt hot & flushed. At the 23hour mark (01Jan2020 20:00), her symptoms became typical flu body aches which was 100% manageable & was a relief after what she had. It was mentioned that she still had terrible fatigue and couldn't do normal activity (in Jan2021). The patient was not sure if she will take the 2nd shot after this. Outcome of the event of fatigue was not recovered; unknown for "couldn't do normal activity" and recovering for the remaining events.
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| 45 | 2021-01-07 | vomiting | vomitting |
| 45 | 2021-01-08 | nausea | Diffuse muscle aches Nausea Fever/chills |
| 45 | 2021-01-08 | nausea |
Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hour...
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Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hours, pulse 100, night sweats, dizziness and slight headache after Tylenol
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| 45 | 2021-01-08 | nausea, vomiting | Headache, Fever & NauseaVomiting |
| 45 | 2021-01-09 | nausea | Chills Fever 103 NauseA Joint pain |
| 45 | 2021-01-09 | diarrhea |
Diarrhea started about 6:30 pm followed by body aches. Within 2 hours I had chills. About 3 am I ha...
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Diarrhea started about 6:30 pm followed by body aches. Within 2 hours I had chills. About 3 am I had a fever of 99.9 degrees F ( normally 97.2 for me). The next day I had a headache and felt fatigue. I had diarhea 3 more times. My spine ached a little when I went to bed about 11pm. No side effects by 1/10/21
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| 45 | 2021-01-09 | nausea |
Woke up with chills and whole body aches almost 12 hrs. After injection. Chills lasted around 3 hrs....
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Woke up with chills and whole body aches almost 12 hrs. After injection. Chills lasted around 3 hrs. I then had extreme fatigue, nausea and headache for another 10hrs.
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| 45 | 2021-01-10 | nausea, difficulty swallowing |
Approximately 5 minutes after vaccination, patient began reporting flushing, shortness of breath, di...
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Approximately 5 minutes after vaccination, patient began reporting flushing, shortness of breath, difficulty swallowing. Presented with elevated BP, pulse, normal O2. Symptoms came in waves with increasing frequency. Nausea also occurred as symptoms continued. Patient was monitored for ~15 minutes before Epi Pen (.03mg) was administered. Patient was transported to hospital by ambulance.
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| 45 | 2021-01-10 | nausea |
HA muscle aches, nausea and dizziness improved. Swelling, pain, itchiness and redness at the injecti...
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HA muscle aches, nausea and dizziness improved. Swelling, pain, itchiness and redness at the injection no treatment no improvement.
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| 45 | 2021-01-10 | diarrhea | Headache, muscle soreness, diarrhea, fatigue |
| 45 | 2021-01-11 | nausea |
Around 6 hours after getting the 2nd vaccine at my place of employment (I am a RN) I was very nausea...
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Around 6 hours after getting the 2nd vaccine at my place of employment (I am a RN) I was very nauseated and dizzy. Couldn?t even walk straight. Then at 0200am I woke up with a 102.8 fever, Heart rate of 159 and body aches along with the dizziness and nausea. It is currently 530pm and I still have all symptoms, heart rate is a little better, around 100. I?m controlling my temperature with Advil and tylenol.
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| 45 | 2021-01-11 | difficulty swallowing | scratchy throat, trouble swallowing |
| 45 | 2021-01-12 | vomiting |
12/22/2021-tingling in left arm/fingers, shoulder pain 12/23-12/25/2021-burning pain between elbow a...
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12/22/2021-tingling in left arm/fingers, shoulder pain 12/23-12/25/2021-burning pain between elbow and shoulder intermittently 12/26/2021-vomiting and constant severe burning pain in left arm. Applied ice pack 12/27/2021-went to ER for the constant severe pain. Given prescriptions for prednisone 60mg orally x two days and norco. Later that night left arm between elbow and shoulder was bright red and hot to the touch. Took Benadryl liquid and the redness/heat went away in 4 hours. Shoulder, tricep, and bicep have continued to hurt with tingling in fingers. Have seen primary care physician at clinic and Dr. with another facility. Have orders for an MRI and follow up with the other facility
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| 45 | 2021-01-12 | abdominal distension, nausea, diarrhea, abdominal pain |
31 hours after receiving the Pfizer vaccine I experienced severe abdominal cramping, bloating, gas, ...
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31 hours after receiving the Pfizer vaccine I experienced severe abdominal cramping, bloating, gas, nausea, & diarrhea. The more severe symptoms started right before 6:30pm and lasted until after midnight. At this time (>48 hrs after vaccine) there is still slight cramping.
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| 45 | 2021-01-12 | difficulty swallowing |
At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck....
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At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck. The next day this continued with a fever of 99-100, malaise, and chest discomfort. At the 48th hour, today?s date, fever still present, body aches are improved, but my head feels hot and now with a stiff neck. I feel very tired and mental status seems ?foggy?
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| 45 | 2021-01-12 | nausea |
The day after the injection I had a itchy red knot appear at the injection site. Starting 27 hours a...
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The day after the injection I had a itchy red knot appear at the injection site. Starting 27 hours after injection I had chills, anxiety, slight shortness of breath, headaches, body aches. Today I have had nausea that comes and goes, the red knot is still present on my right arm and the redness has increased a small amount from the marking placed last night. The injection is not in my deltoid muscle or even close and I am wondering if that is at the least what created the redness and the knot.
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| 45 | 2021-01-13 | nausea |
1. Dec. 30, 2020- Headaches for about 24hrs after 1st COVID-19 injection, treated w/ 500 mg of Ibupr...
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1. Dec. 30, 2020- Headaches for about 24hrs after 1st COVID-19 injection, treated w/ 500 mg of Ibuprofen at 1:00 am, reduced/eliminated headaches by Dec. 31, 2020 3:00 p.m. 2. Jan. 01, 2021- Woke up/laying down when the dizziness/room spinning began lasting about 10 seconds. Dizzy/spinning episodes continued from 01/01/2021-01/05/2021 (decreasing in episodes on 01/04/2021- 01/05/2021). The dizzy/spinning episodes would happen randomly when I first woke up, through out the day/night, about 6-7 times a day, and lasting about 10 seconds. A few times I felt like I would faint. Treated with rest, sleep, drinking water, and took off work for 1 week due to the danger of driving or going outside the home. 3. I would randomly wake up with hot sweats and nausea from 01/01/2021-04/01/2021, treated by drinking water, and resting. 4. I experienced the general feeling of being unwell, fatigue, and foggy mind that lasted about a week after the 1st COVID-19 vaccination. Treated with rest and was off work for 1 week.
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| 45 | 2021-01-13 | nausea |
45 y/o FEMALE WHO REFERED NAUSEAS AFTER COVID VACCINATION 30 MINUTES BEFORE. B/P 144/87, SAT 100%, R...
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45 y/o FEMALE WHO REFERED NAUSEAS AFTER COVID VACCINATION 30 MINUTES BEFORE. B/P 144/87, SAT 100%, RESP FRE. 16 PER MINUTE. PATIENT WAS DICHARGE HOME AT 2:40 PM SAME DAY. FOLLOW UP WITH PRIMARY CARE MD PATIENT STATED SHE WAS FEELING WELL N O NAUSEAS AT TIME OF DISCHARGE.
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| 45 | 2021-01-13 | nausea |
Headache, dizziness, fatigue, and night sweats, and slight nausea. I took Aleve for the headache, it...
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Headache, dizziness, fatigue, and night sweats, and slight nausea. I took Aleve for the headache, it did help.
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| 45 | 2021-01-13 | nausea | Headache, nausea, fever of 103, chills, fatigue |
| 45 | 2021-01-13 | nausea |
On 1/13/21 extreme fatigue- sleeping 4 to 5 hours at a time, swollen gland on right side 1/14/21 nau...
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On 1/13/21 extreme fatigue- sleeping 4 to 5 hours at a time, swollen gland on right side 1/14/21 nausea, headache, dizziness, fever-100.7, muscle ache, swollen gland still
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| 45 | 2021-01-13 | nausea |
Severe headache, nausea and fever only marginally relieved with Benadryl, Zofran, Tramadol, Pepcid, ...
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Severe headache, nausea and fever only marginally relieved with Benadryl, Zofran, Tramadol, Pepcid, Tylenol. Symptom onset evening of 12.29 and increasing over the next several hours, finally beginning to resolve around noon on 1.1.21. Patient was in contact with her Oncologist who is recommending second dose with additional prophylaxis. Not evaluated in person.
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| 45 | 2021-01-13 | diarrhea | Slight body aches, diarrhea and mild headache |
| 45 | 2021-01-13 | nausea |
shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nau...
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shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nausea, skin burning sensation, facial swelling
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| 45 | 2021-01-14 | diarrhea |
Diarrhea within 30 minutes, lasting a few days following; This is a spontaneous report from a contac...
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Diarrhea within 30 minutes, lasting a few days following; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK921, on 07JAN2021 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included hypothyroid from an unknown date and unknown if ongoing, hyperlipidemia from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. The patient did not have known allergies. Concomitant medication included levothyroxine, atorvastatin, lisinopril, and sertraline hydrochloride (ZOLOFT). The most recent COVID-19 vaccine was administered in the hospital. No other vaccines were given in 4 weeks. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 07Jan2021 12:30 PM the patient experienced diarrhea within 30 minutes, lasting a few days following. The diarrhea within 30 minutes, lasting a few days following did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the event diarrhea within 30 minutes, lasting a few days following. Outcome of the event diarrhea within 30 minutes, lasting a few days following was recovering. Since the vaccination, the patient has not been tested for COVID-19.
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| 45 | 2021-01-14 | nausea, vomiting |
Fever 101.2 orally; chills; body aches; headache; nausea; vomiting; first dose on 18Dec2020, second ...
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Fever 101.2 orally; chills; body aches; headache; nausea; vomiting; first dose on 18Dec2020, second dose on 07Jan2021; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm, first dose (lot number: EL0140) on 18Dec2020 at single dose then second dose (lot number: EK9231) on 07Jan2021 18:45 at single dose for COVID-19 vaccination. Medical history included hypertension, depression, osteoarthritis (OA) and known allergies to ACE inhibitors and sulfa eye drops, on unspecified dates. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not have COVID-19 prior to vaccination. Concomitant medications in 2 weeks included losartan, bupropion, fluoxetine hydrochloride (PROZAC), triamcinolone acetonide (NASACORT), naproxen sodium (ALEVE), and colecalciferol (VITAMIN D) from unspecified dates. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient experienced fever 101.2 orally, chills, body aches, headache, nausea, vomiting on 08Jan2021, 5 hrs 15 min onset from last dose on 07Jan2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events includes paracetamol (TYLENOL), ondansetron (ZOFRAN). Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101.2 (unit unknown) on 08Jan2021, and SARs-CoV-2 test (COVID test) with unknown results on an unspecified date. The outcome of the events was not recovered.
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| 45 | 2021-01-14 | nausea, diarrhea |
Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administrati...
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Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administration, and blurry vision. Still having blurry vision and diarrhea after 3 days
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| 45 | 2021-01-14 | nausea |
Received vaccine 1/13/21 at 10:30 am. Felt fine all day. Woke up next day 1/14/21 at 5 AM with feve...
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Received vaccine 1/13/21 at 10:30 am. Felt fine all day. Woke up next day 1/14/21 at 5 AM with fever 101.0, body aches, dizziness, fatigue enlarged lymph node at left axilla, same side as shot, mild nausea, and a sore left arm. Felt sick for about 12 hours with these symptoms, fever resolved slowly with ibuprofen. Symptoms mostly resolved in 24 hours, except I still have an enlarged lymph node - left axilla with throbbing pain. No fever.
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| 45 | 2021-01-14 | nausea |
fever; body aches; severe nausea; This is a spontaneous report from a contactable healthcare profess...
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fever; body aches; severe nausea; This is a spontaneous report from a contactable healthcare professional reporting for self. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 02Jan2021 at 12:00 PM (Dose 1) as a single dose in the left arm (age at vaccination: 45 years old) for COVID-19 immunization. There was no relevant medical history. She did not have COVID prior to vaccination. There were no allergies to medications, food, or other products. The patient's concomitant medications were not reported; there were no other medications taken in the 2 weeks prior. The patient received the COVID vaccine at 12:00 PM on 02Jan2021. Exactly 12 hours later, on 03Jan2021 at 12:00 AM, she began having a fever, body aches, and severe nausea. This had continued all week. The patient was COVID tested post-vaccination on 04Jan2021 via nasal swab with a negative result. "Yesterday" (as of 08Jan2021) she went to immediate care (physician office) and the doctor said that she had a bad reaction to the vaccine and shouldn't be having fevers every day and if they continue she may need to go to the emergency room. She was tested for other illnesses and everything was negative. Therapeutic measures were taken as a result of severe nausea and included ondansetron (ZOFRAN). The outcome of the events fever, body aches, and severe nausea was recovering. She reported the events as non-serious and confirmed there was no hospitalization. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 45 | 2021-01-15 | nausea |
Headache started a couple hours after injection and lasted for days. Muscle pain, neck pain, naus...
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Headache started a couple hours after injection and lasted for days. Muscle pain, neck pain, nausea, fatigue, altered taste bitter,
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| 45 | 2021-01-16 | abdominal pain upper, nausea |
2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head woul...
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2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head would explode- severe left eye pain like my eyeball was going to Pop out 4 hrs post shot- chills no fever temp 97.1 fatigue- took a nap. 12 hrs post shot - severe headache, moderate arm pain and mild swelling at site. SEVERE joint pained tiny joints in ties feet, finger, wrists, neck jaw. Knees were the worst. 16 hours later the joint pain is unbearable . Muscle aching and headache continues at the same time as joint pain. 24 hours post Injection. Chills,moderate painful stomach aching from the inside. Nausea. No vomiting, no energy. Could not work, had to leave. 29 hours post shot- now all symptoms at the same time chills, headache, severe joint pain, stomach pain, nausea, felt like I couldn?t drive home or walk to my car. Got home. Called dr. Went to bed. Slept 14 hours. 48 hours post shot- symptoms decreasing. Headache mild joint pain is the worst. Tired and very cold feeling 72 hours- feeling much better.
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| 45 | 2021-01-16 | nausea | Fever, muscle spasms to the point of difficulty walking, severe nausea |
| 45 | 2021-01-16 | vomiting | Vomiting, dizzinesz |
| 45 | 2021-01-17 | nausea, abdominal pain, decreased appetite |
4am 1/16: fever, chills, headache, and myalgia. Allodynia of scalp trunk and thighs, Acetaminophen a...
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4am 1/16: fever, chills, headache, and myalgia. Allodynia of scalp trunk and thighs, Acetaminophen and Aspirin helped somewhat. 9pm severe fatigue, followed by worsened fever, worsened headache, throat tightness, nausea, myalgia, and waking hourly until 8am. Oral temp at 9am (1/17) was 100.6. Acetaminophen plus aspirin helped. 1/17 all day headache, malaise, poor appetite, and crying. 1/18 woke every 3rd hour to change clothes from night sweats. By 9 am had abdominal cramps, low grade headache, still malaise, and still low appetite. Still not recovered fully.
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| 45 | 2021-01-17 | difficulty swallowing |
Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response. Treatment...
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Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response. Treatment: epipen, IM Benedryl shot x2, ambulance transport to ER at Hospital for monitoring Outcome- deduced symptoms and eventual absence of symptoms 24 hours later
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| 45 | 2021-01-17 | vomiting, nausea |
Note: Employee submitted additional information after first VAERS report:Was Positive COVID in Nove...
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Note: Employee submitted additional information after first VAERS report:Was Positive COVID in November. Received first vaccine on 1/7. Headache and body aches started next evening and continued for next 72 hours that were manageable with Tylenol. On Monday 1/11, headache became more severe and started having light nausea. Tuesday 1/12 headache was severe and acute nausea and vomiting began along with a light fever, body aches, low grade fever, nausea and vomiting. Thursday went to ED in the afternoon to receive fluids (2L) and IV anti-nausea meds (zofran and reglan). Vomiting stopped after ED visit. Nausea, fatigue and body aches continued into Friday. Saturday symptoms decreased significantly. Sunday/Monday only a light headache and back to "normal".
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| 45 | 2021-01-17 | abdominal pain upper, diarrhea | Sudden onset stomach cramping, followed by diarrhea |
| 45 | 2021-01-17 | decreased appetite, nausea |
nausea, lump/swelling under left arm/breast, headache severe, body aches at the slightest touch, pai...
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nausea, lump/swelling under left arm/breast, headache severe, body aches at the slightest touch, painful eyes from 1/15-1/17 w/ headache severe, loss of appetite, nausea lasting from 1/15-present day.
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| 45 | 2021-01-18 | nausea | Body Aches , Chills, 100.9 Temp , Fatigue , nausea , Skin hurt |
| 45 | 2021-01-18 | nausea | Nausea, mild headache |
| 45 | 2021-01-18 | diarrhea |
Night of 2nd dose had chills/body aches. Developed diarrhea next day. Arm became swollen and sore,...
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Night of 2nd dose had chills/body aches. Developed diarrhea next day. Arm became swollen and sore, red and itchy. Continued to get progressively more red, sore, itchy and swollen. On day 5 post vaccination, seeing by primary care doctor and diagnosed with cellulitis. Placed on antibiotics.
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| 45 | 2021-01-18 | decreased appetite |
Sleepiness; pain at site for >24hrs less than 48hrs; itching on arm below injection site; headache; ...
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Sleepiness; pain at site for >24hrs less than 48hrs; itching on arm below injection site; headache; petichiae on site arm below injection site; sneezing; vivid dreams; swelling in legs; lower appetite; thirsty; more frequently urination with larger amounts; more frequently urination with larger amounts; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 04Jan2021 at 15:45 on arm at single dose for COVID-19 immunization. Medical history included Chronic sinusitis and had known allergies with Gluten and Sulfa. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took tizanidine hydrochloride (TANIN, reported as tanins) and had known allergy. The patient experienced sleepiness, pain at site for more than 24hours less than 48hours, itching on arm below injection site, headache, petichiae on site arm below injection site, sneezing, vivid dreams, swelling in legs, lower appetite, thirsty, more frequently urination with larger amounts on 04Jan2021 at 19:00. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No. Information on the lot/batch number has been requested.
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| 45 | 2021-01-19 | nausea | Neck pain Head pressure Dizzy Nauseous Very Fatigue Very sore site (R) arm |
| 45 | 2021-01-19 | nausea |
Patient is a 45 year old female with no significant PMHX who presents today high blood pressure, nau...
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Patient is a 45 year old female with no significant PMHX who presents today high blood pressure, nausea and chills within 30 min of receiving the 1st dose of the COVID-19 vaccine 4 hours ago Denies rash, shortness of breath, vomiting, diarrhea, trouble swallowing or breathing, swelling of throat, tongue, lips or eyes. No fever. Patient states her BP was taken when she was having the symptoms and it was 170s systolic. Patient is presenting today with report of nausea, chills and elevated BP s/p COVID-19 vaccine. Patient has no evidence of anaphylaxis or severe allergic reaction. . Patient has normal vitals and in no respiratory distress. Will discharge home with close outpatient follow-up.
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| 45 | 2021-01-19 | vomiting, abdominal pain, diarrhea, nausea |
Slight Headache (ibuprofen) Fatigue (sleep) Vomiting Nausea (crackers, peppermint tea) Abdominal pa...
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Slight Headache (ibuprofen) Fatigue (sleep) Vomiting Nausea (crackers, peppermint tea) Abdominal pain after eating and woke up with it 1/20/2021 (still happening) Diaherra (stopped on 1/19/2021)
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| 45 | 2021-01-19 | nausea |
a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, thro...
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a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, throbbing headaches, difficulty operating a vehicle. The dizziness has now gotten bad enough that it is causing nausea.
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| 45 | 2021-01-20 | diarrhea |
Body aches, tingling in lip/tongue, tongue swelling, fever, tingling in left arm above the elbow, di...
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Body aches, tingling in lip/tongue, tongue swelling, fever, tingling in left arm above the elbow, diarrhea, rash, sore throat, headache
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| 45 | 2021-01-20 | nausea |
Got it yesterday at noon, totally fine until 10pm. Worsening chills until midnight, then complete b...
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Got it yesterday at noon, totally fine until 10pm. Worsening chills until midnight, then complete body ache, muscles, joints, everything, terrible headache. Was on couch and walked upstairs. By the time I got there, I was nearly vomiting and on the verge of losing consciousness. I laid down on the cold tiles and tried to stay conscious. I couldn't even talk. Saliva was pouring out of my mouth uncontrollably. After awhile it let up enough to scoot into the bedroom and climb into bed. Then an entire night of worsening chills, fever, aches, eye pain, sore throat, pulsating ringing in my ears. Little if any sleep. I tried to get up and sit in a chair this morning at 3am and within minutes was so nauseated and light headed I had to lay back down flat. Tried to drink some hot tea and Gatorade at 5am. Thought I heard someone walking around the house and then realized it was heartbeat pounding in my ears. This morning my feet are super sensitive, I have urinary frequency and urgency, and the pulsatile tinnitus is back. Later today had episode of sharp chest pains front to back that resolved after about five minutes. Treatment has been rest today.
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| 45 | 2021-01-20 | vomiting |
High temperature starting at 3:00 am (101.84, 38.8 Celsius), severe headache, pain all over the bo...
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High temperature starting at 3:00 am (101.84, 38.8 Celsius), severe headache, pain all over the body and shortness of breath, as soon as I tried to drink water I threw up, extreme tiredness and weakness. Slept basically the whole Sunday (1/17). Around late afternoon it started getting better and I was able to eat some soup. But still tiredness and weakness and shortness of breath. I took Ibuprofen 600 3 times that day but it didn't help. On Monday 1/18 headache got better but still extreme shortness of breath and weakness and back pain. Today 1/21 I'm still having shortness of breath and back pain.
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| 45 | 2021-01-20 | vomiting, nausea | Migraine with nausea and vomiting, extreme fatigue x 48hrs |
| 45 | 2021-01-20 | nausea | Migraine, exhaustion x 48hrs, nausea |
| 45 | 2021-01-20 | nausea |
Pt. developed nausea, 15 minutes after vaccine dose, denied shortness of breath, abdominal pain or o...
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Pt. developed nausea, 15 minutes after vaccine dose, denied shortness of breath, abdominal pain or other associated symptoms. She had no skin or other changes noted
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| 45 | 2021-01-20 | vomiting |
Site soreness,body ache,headache,chilling12/28/21 Tylenol around-the-clock, ice for site soreness 1...
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Site soreness,body ache,headache,chilling12/28/21 Tylenol around-the-clock, ice for site soreness 12/30/20 vomitted
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| 45 | 2021-01-21 | abdominal pain | Fever , severe chills , body aches , abdominal pain , arm pain |
| 45 | 2021-01-21 | abdominal pain upper |
Large baseball sized, painful, hard, reddened, lump on arm day one decreased to golf ball size 4 da...
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Large baseball sized, painful, hard, reddened, lump on arm day one decreased to golf ball size 4 days later. I had moderate chills progressed to severe chills, stomach pain, and muscle/joint pain. Unable to work following day. I reported. It advised someone would be calling me. No one ever did. Chills, stomach and joint pain resolved. Still fatigued with painful lump on arm.
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| 45 | 2021-01-21 | nausea |
Muscle cramps, fever, nausea, chills, headache , Pain in armpit Treated with Tylenol, ibuprofen ,...
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Muscle cramps, fever, nausea, chills, headache , Pain in armpit Treated with Tylenol, ibuprofen , and mucinex cold and flu
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| 45 | 2021-01-21 | vomiting, diarrhea, nausea |
R arm pain, fatigue after 1st shot. After second shot sinus pressure, started 1 hr after shot. Foll...
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R arm pain, fatigue after 1st shot. After second shot sinus pressure, started 1 hr after shot. Following day, r arm sore, fatigue sinus pressure continued. After second day, no more fatigue, sinus pressure but developed vertigo with nausea, vomiting and diarrhea.
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| 45 | 2021-01-23 | diarrhea |
Diarrhea temp fatigue muscle aches no appetite. seen dr Blood tests done. White an...
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Diarrhea temp fatigue muscle aches no appetite. seen dr Blood tests done. White and red blood cells elevated. Dx with reaction to vaccination.
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| 45 | 2021-01-23 | nausea | Vertigo, nausea beginning 1/24, slightly under 48 hours from 2nd vaccine administration. |
| 45 | 2021-01-24 | decreased appetite, nausea |
I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm,...
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I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm, the worse headache ever, feeling nauseous and my body was so sore. Throughout the day I felt weak, sleepy and got light headed and went to bed. I had no appetite but I was very thirsty. I didn?t eat Sunday. Today (Monday) I woke up with those same issues and more. I have a sore throat it feels tight, I?m dizzy and just feel sick all around and still have no appetite but I?m thirsty and my finger tingle.
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| 45 | 2021-01-24 | abdominal pain |
Left was sore on 1/18. 1/19 Woke up very congested. 1/19 went into work, she lost her voice and eye...
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Left was sore on 1/18. 1/19 Woke up very congested. 1/19 went into work, she lost her voice and eyes, face and neck swollen- felt like her throat was swelling
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| 45 | 2021-01-24 | nausea | Nausea, "crawling skin", achy muscles/joints, only lasted until 1/24 at around 8:00pm. |
| 45 | 2021-01-25 | abdominal pain upper, nausea, abdominal pain, diarrhea |
I felt mostly fine all day. A little tired and my arm was sore. About 4:45pm, I started sweating a...
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I felt mostly fine all day. A little tired and my arm was sore. About 4:45pm, I started sweating and getting really hot. I felt like I might need to use the restroom (soon) and I was at the grocery store. So, I immediately left. My house is 5-7 minutes from the store. During this time, I experienced terrible pains in my stomach and lower abdomen. I barely made it through my door and had to run to my bathroom. I experienced diarrhea like I?ve never experienced in my life. It was painful and explosive. This lasted about 30 minutes on and off. Mostly on. Once I cleaned myself up, I was very tired and weak. I felt nauseous this entire night but have not had any other episodes. I also have not invested anything except water since this happened.
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| 45 | 2021-01-25 | difficulty swallowing |
Patient received her first dose of the Pfizer vaccine and appeared well. Patient was told to sit for...
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Patient received her first dose of the Pfizer vaccine and appeared well. Patient was told to sit for 30 min to monitor for reaction. After 5 min, patient reported feeling dizzy, tongue feeling slightly swollen, chills, slight difficulty swallowing her own saliva. She denied difficulty breathing, racing heart. NP on site notified, who performed a focused assessment and administered 50 mg IV Benadryl IM. Patient was reassessed and monitored by NP and two RN. Patient reported instant symptom relief within 2-4 min, that her chills went away and no issues swallowing and felt "90%" better. After 15 mins patient reported she was feeling symptoms again come back. Patient was escorted to the ED with NP and RN immediately.
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| 45 | 2021-01-25 | difficulty swallowing |
Started to feel bad when I left after 15 minutes wait time. Upon leaving I almost pulled into the ho...
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Started to feel bad when I left after 15 minutes wait time. Upon leaving I almost pulled into the hospital parking lot to wait, but decided to try and drive home. I began to feel light headed, dizzy, dry mouth, it felt hard to swallow. I knew I did not feel well so I drove myself to the fire station that was closest to me. They took my blood pressure upon arrival and it was 141/93. My normal blood pressure is around 116/63, so it was considerably high. I do not have a history of high blood pressure. The morning of the vaccination I had, had a very small cup of coffee and had eaten a piece of raisin bread. I had also taken two 250 mg generic acetaminophen tablets with 65mg caffeine prior to the vaccination. I also experienced chills and a low grade fever of 100 degrees.
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| 45 | 2021-01-25 | difficulty swallowing, difficulty swallowing | throat tightening, dizziness, difficulty swallowing |
| 45 | 2021-01-26 | decreased appetite |
I'd heard about these side effects, was more than I expected, couldn't go to work that day since I w...
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I'd heard about these side effects, was more than I expected, couldn't go to work that day since I was in bed with side effects. Felt like more than any vaccine I'd received in my life, so decided to report just since this is a new vaccine. About 10 hours after vaccine, chills and fever started, fever up to 101, body weakness, lack of appetite, headache/migraine. Insomnia that night, up all night due to symptoms. . All symptoms except migraine resolved over the next 24 hours. Migraine continued so I took 50 mg imitrex x 3 over the course of the next 36 hours until that finally resolved . So all symptoms gone after around 2.5=3 days.
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| 45 | 2021-01-27 | nausea |
5 days after the first shot(12/24/2020), I started feeling extremely fatigued. I had axilla lymphad...
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5 days after the first shot(12/24/2020), I started feeling extremely fatigued. I had axilla lymphadenopathy, dizziness, nausea, joint pain, muscle pain and periods of tachycardia when standing. This lasted for 7 days. The lymphadenopathy was diagnosed in a routine mammogram/ultrasound screening 9 days after the vaccine. I finally started feeling better the week I was scheduled to receive my second shot. I got my second shot on 1/14/2021. Within 12 hours, I had a 101 fever and muscle aches. I also had axilla lymphadenopathy. Within 3 days, I was feeling better, however about 8 days post vaccine, I started to experience bouts of tachycardia and dizziness again. As time progresses, these symptoms are slowly improving.
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| 45 | 2021-01-27 | abdominal pain upper |
Fatigue, Hot and cold body temperature, chills, dizziness, flighty-light headed, night sweats, stoma...
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Fatigue, Hot and cold body temperature, chills, dizziness, flighty-light headed, night sweats, stomach and back pain
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| 45 | 2021-01-27 | vomiting, nausea | High Fever Body aches Headache Nausea Vomiting |
| 45 | 2021-01-27 | diarrhea |
Sore L arm; body aches; chills; diarrhea; headache; This is a spontaneous report from a contactable ...
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Sore L arm; body aches; chills; diarrhea; headache; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL8982, expiration date unspecified), intramuscular on 14Jan2021 15:30 at single dose (left arm) for Covid-19 immunization. Medical history included vitamin d deficiency (def), Beta Thalassemia, some shellfish allergy, Sulfa allergy and COVID-19, which was prior to vaccination. Concomitant medication included vitamin D3. The patient received vitamin D3 within 2 weeks of vaccination. On 15Jan2021 at 06:45, the patient experienced sore left (L) arm, body aches, chills, diarrhea, and headache. The patient did not received treatment for the events. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had not been tested for Covid-19 since the vaccination. Outcome of events was recovering.
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| 45 | 2021-01-27 | nausea, diarrhea, vomiting |
moderate headache; body ache; tender arm; diarrhea; chills; nausea; vomiting; This is a spontaneous ...
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moderate headache; body ache; tender arm; diarrhea; chills; nausea; vomiting; This is a spontaneous report from a contactable Other Health Professional reporting for herself. A 45-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142), via an unspecified route of administration on 15Jan2021 09:00 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 45 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. She received unspecified concomitant medications. On 16Jan2021 at 23:45 the patient experienced moderate headache, body ache, and tender arm and 40 hours after the dose, she developed diarrhea, chills, nausea & vomiting lasting 4 hours. All the events were considered non serious. No treatment was received for the events. The events had resolved on an unspecified date in Jan2021. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 45 | 2021-01-28 | nausea |
26th January 2021-after the injection-she became foggy funny headed for about an hour-her words 27th...
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26th January 2021-after the injection-she became foggy funny headed for about an hour-her words 27th January 2021-Chills, nauseated 28th January 2021-Body aches, left deltoid area extra tender, nauseated, HA, she has a history of migraines 29th January 2921-A lot better today she took Tylenol for her symptoms-told to go to the ER if her symptoms get worse, PCM if she needs to
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| 45 | 2021-01-28 | nausea |
Pt waited her 15 minute waiting period without issue. Pt then left the clinic & reports that she did...
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Pt waited her 15 minute waiting period without issue. Pt then left the clinic & reports that she did not feel right so she came back to the clinic. Pt reported some numbness & tingling in her arms & hands, nausea, increased anxiety, & shaking. 1mL dexamethasone 4mg/mL given IM to right buttock. Pt placed on 2LPM 02 via NC for comfort. Pt tolerated well.
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| 45 | 2021-01-28 | abdominal pain, abdominal pain upper, nausea |
Reported had severe headache the same night. Worse the next day. Tongue and lip swelling. BP spike...
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Reported had severe headache the same night. Worse the next day. Tongue and lip swelling. BP spiked, severe headache, severe abd pain, seen at Urgent Care and sent to ER. Given meds and sent home. Next day seem at clinic and again sent to ER. . Given IV fluids, IV meds and after four hrs sent home. Experienced extreme weakness. Could barely get out of chair or walk. ED visit 1/15/2021 for acute nonintractable headache, epigastric pain, adverse effect of vaccine. Presents to the ER with epigastric abdominal pain, nausea, and headache after receiving second dose of Pfizer COVID-19 vaccination yesterday at 6 AM. Patient states symptoms started last night. Treated with IV fluids, Reglan, Benadryl, Toradol, and Floricet. Abdominal pain totally resolved and headache pain improved. Discharged to home with prescription for Reglan 10mg PRN. She does have a history of chronic migraines and already has Maxalt at home and was given a prescription for Floricet today which she is already filled.
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| 45 | 2021-01-28 | abdominal pain | SEVERE ABDOMINAL PAIN |
| 45 | 2021-01-31 | diarrhea | 100.6 fever, diarrhea, very sore and hard injection site. called in sick to work. |
| 45 | 2021-01-31 | indigestion, abdominal pain |
DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT...
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DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT: acute tingling around mouth and tongue; BP spiked and face became very flushed. Waited with nurse until 1 hour post shot. BP stayed above normal all day, as did fatigue. 12 HOURS POST SHOT: sever headaches warranting migraine medicine but I only took Tylenol and Ibuprofen since Maxalt (10 mg) can raise BP. Alternated Tylenol and Ibuprofen every 3 hours but would only get about 2 hours of relief each time. This continued through the night. DAY 2 (Fri. 1/15/21): 23 HOURS POST SHOT: Headache remained. but was lessened after taking Mucinex D. Extremely fatigued, which remained throughout the day. 24 HOURS POST SHOT (9:00 am): Saw NP at clinic, BP was normal. Was prescribed Fioricet, ESGIC 50-325-40 and advised to take it if headache returned. If ineffective after 2 hours, advised to take Maxalt 10 mg. 10:10 am: took Fioricet with no impact to headache, took Maxalt at 12:10. 28 HOURS POST SHOT: Severe, painful heartburn in my chest and upper back - Mylanta provided no relief. Headache returned and started having severe abdominal pain and shortness of breath. 29 HOURS POST SHOT (~2PM) Went to urgent care; vitals were all normal. Received fluids and "GI cocktail" containing lidocaine. Heartburn pain subsided but headaches and abdominal pain. Was advised to go to Emergency Department and did. ED ran multiple labs and ECG to rule out gallbladder, pancreas, etc. Headaches and abdominal pain at this point were excruciating and debilitating. Shortness of breath was significant. ED staff said they have seen the different reactions I was having to the vaccine, just not all together in one patient at the same time. Pain subsided after fluids with Benadryl, Toradol and Reglan. Was discharged approximately 4 hours after arrival. MD prescribed Reglan for continued headaches through the weekend. DAY 3 (Sat. 1/16/21): 48 HOURS POST SHOT: Severe headache when I awoke. Reglan did not provide relief. After two hours, took Maxalt 10 mg . Headaches and significant fatigue continued with such severity I took Maxalt as frequently as allowed per dosing instructions. I stayed in a dark room until Monday (1/18/21, Day 5), ensuring I was staying well hydrated and nourished. The fatigue was so significant that movement was very labored. It should be noted that I am a very active person and I had zero energy and missed two days of work (Fri and Mon). DAY 4: headaches were less frequent DAY5 (Mon. 1/18/21): At 3:30 PM (~126 hours post shot) - it was like someone flipped a light switch and the fatigue and headaches were gone and I felt like I was back to normal. DAYS 6-7, (Tues. and Wed 1/19-20/21) - worked a normal day at work. DAY 8 (Thu. 1/21/21): extremely fatigued again, like over the weekend, but it only lasted today. Of note, the lips and tongue tingling would come and go following the initial weekend of severe reactions. While noticeable, it was not as significant as within the first 15 mins of receiving the dose. On Monday 1/25/21 at approximately 3:00 PM, the tingling was very noticeable and my BP spiked again. Since that time until now, I have had no reactions.
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| 45 | 2021-01-31 | nausea |
Got vaccine at 930am. Woke up morning after the vaccine about 930am with tingling/severe pain should...
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Got vaccine at 930am. Woke up morning after the vaccine about 930am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then tylenol mid day. That evening had fatigue and pain all over, slight head ache, chills and then turned to temp 99.9, very warm/uncomfortable. Tylenol again. Woke on Sunday better just fatigue and achy.
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| 45 | 2021-01-31 | vomiting, diarrhea, nausea |
Later that night she felt like she had the flu, nausea, vomiting, later that day diarrhea, and a mig...
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Later that night she felt like she had the flu, nausea, vomiting, later that day diarrhea, and a migraine at Left temple area, sweating, hot and cold chills, after she was able to eat she felt better
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| 45 | 2021-01-31 | nausea |
Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swol...
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Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swollen lymph under jaw on neck.
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| 45 | 2021-01-31 | vomiting, nausea | nausea, emesis, syncope, as well as extended tiredness, headache, joint pain, fever |
| 45 | 2021-01-31 | nausea, decreased appetite |
nausea; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling an...
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nausea; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; headache; body aches at the slightest touch; fever; loss of appetite lasting 4 days; left upper arm/underarm/breast swelling and pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiration date not provided), intramuscular in the left arm on 14Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and hypothyroidism. The patient is not pregnant. The patient has no know allergies. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and no other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Jan2021 02:45, the patient experienced nausea, left upper arm/underarm/breast swelling and pain, headache nothing would take away, body aches at the slightest touch, fever, loss of appetite lasting 4 days and still with nausea, loss of appetite and headache. Treatment was not provided in response to the events. The outcome of the events was recovered with sequelae on an unspecified date in Jan2021. The patient has not been tested for COVID post vaccination.
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| 45 | 2021-02-02 | nausea |
Flu like symptoms: started getting week and tired. Went to bed about 11pm and could barely get up in...
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Flu like symptoms: started getting week and tired. Went to bed about 11pm and could barely get up in the morning at 4:30 am. Headache, low grade fever of 99.7, achy all over, a bit of nausea.
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| 45 | 2021-02-03 | diarrhea |
Approximately 18 hours post injection I began running a fever with severe body aches and headache. 2...
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Approximately 18 hours post injection I began running a fever with severe body aches and headache. 24 hours after onset of initial symptoms, I developed diarrhea. 72 hours after injection, I noted a large painful lymph node in the axilla of the injection side. Fever and malaise continue in addition to cough and chest tightness
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| 45 | 2021-02-03 | nausea |
I started to have aches, joint pain and a migraine with slight nausea on 2/1/21 @ 1700 after having ...
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I started to have aches, joint pain and a migraine with slight nausea on 2/1/21 @ 1700 after having the 2nd vaccine earlier that morning. The migraine persisted till 2/3/2021 at 0930. I called employee heath and was suggested to take some Tylenol and coffee. I continue to have mild joint pain, a mild headache, and no nausea.
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| 45 | 2021-02-03 | nausea |
Nausea; Chills; Headache; Cough; This is a spontaneous report from a contactable healthcare professi...
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Nausea; Chills; Headache; Cough; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on left arm on 19Jan2021 14:15 at single dose for covid-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol, lisinopril, estradiol, sertraline and tramadol hydrochloride (TRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, chills, headache, cough, all on 19Jan2021. The events were assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of the events was recovering.
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| 45 | 2021-02-03 | nausea |
first dose was administered on 03Jan2021 and second dose was administered on 15Jan2021; pain at inje...
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first dose was administered on 03Jan2021 and second dose was administered on 15Jan2021; pain at injection site; Muscle pain; joint pain; nausea; This is a spontaneous report from a non-contactable other health professional. A 45-year-old female patient received second dose oBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number and expiry not available), via an unspecified route of administration, in the left arm, on 15Jan2021 13:00 at a SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. Patient was not pregnant during vaccination. Historical vaccine included BNT162B2 on 03Jan2021 at 02:00 PM, in the Left arm (1st dose) for COVID-19 immunization. Concomitant medications included Birth control (unspecified) and sertraline hydrochloride (ZOLOFT). The first dose was administered on 03Jan2021 and second dose was administered on 15Jan2021. On 15Jan2021, the patient experienced muscle pain, joint pain, nausea and pain at injection site. The patient underwent lab tests and procedures which included covid test via nasal swab post vaccination (on 15Jan2021) with unknown result. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number cannot be obtained.
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| 45 | 2021-02-03 | nausea |
impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more...
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impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more dizziness with visual disturbances; increasingly more and more dizziness with visual disturbances/She feels things are moving that aren't; This is a spontaneous report from a contactable physician, the patient. A 45-year-old female physician received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231, Expiry: Apr 2021), intramuscularly in the left deltoid on 30Dec2020 at 16:30 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included heartburn. Concomitant medications included (dexlansoprazole) DEXILANT for heartburn from an unspecified date (reported as a year and a half). The patient did not receive any other vaccinations within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced dizziness with visual disturbances. She was having increasingly more and more dizziness with visual disturbances where today (20Jan2021) she felt nauseous from that. It was impairing her from driving because she felt things were moving that weren't and made her panic on the interstate, as of an unspecified date. It. Initially it was bothering her while driving, but now she noticed it while sitting at her desk or when she ate. It was all the time now. The reporter assessed the events "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" as being between disabling and medically significant. The patient did not visit the emergency room or a physician's office, although stated it probably did require it. The patient queried whether to receive the second dose today as her symptoms were worsening. The clinical outcome of "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" was not resolved, and of nauseous, "impairing her from driving/ bothering her while driving" and panic were unknown.; Sender's Comments: Based on a compatible temporal relationship causality between events dizziness with visual disturbances and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-02-04 | diarrhea, nausea | BODY ACHES, NAUSEA, DIARRHEA |
| 45 | 2021-02-04 | nausea |
My arm at the injection site got very swollen and red and I had red streaks across my back. Symptoms...
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My arm at the injection site got very swollen and red and I had red streaks across my back. Symptoms began 14 hours after injection. I had the normal fever, nausea, chills, body aches, also had severe ear pain in my left ear same as when I had Covid. Dizziness began 14 hours after but increasingly got worse. My blood pressure went up to 200/118 with my HR 131 with the dizziness. I have NEVER had high blood pressure!! I still have some dizziness. Not completely resolved. BP is better but still high at times. I have been monitoring it closely. I did go to the ER where my BP continued to be high.
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| 45 | 2021-02-04 | nausea |
On January 27, 2021 at around noon I received the first dose of the Pfizer/BioNTech Covid-19 vaccine...
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On January 27, 2021 at around noon I received the first dose of the Pfizer/BioNTech Covid-19 vaccine. After approximately 10-15 minutes I noticed a reaction. I was really lightheaded , short of breath, and shaking. It felt like I was going to pass out. I was given water and a bar to eat, and eventually I got to a place where I felt that I could drive. I went for a walk with a couple of friends, but was having a hard time walking because of shortness of breath, and was still lightheaded plus I had skin tingling on both sides of my face. I ate something afterward the walk and felt better within an hour. The next day I seemed to be fine, but then Friday (two days after the shot) I became increasingly lightheaded/dizzy and nauseous. Additionally, I had issues on Friday and Saturday with anxiety and trying to hold off mild panic attacks plus depression and nausea. I was still lightheaded/dizzy and had shortness of breath for a week after the shot. which has extend to today (February 5, 2021), over a week after the shot.
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| 45 | 2021-02-05 | nausea, vomiting |
Patient felt nauseated and hot. Laid down and given water. About 10 minutes later, patient had cl...
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Patient felt nauseated and hot. Laid down and given water. About 10 minutes later, patient had clear emesis (small amount). Patient sat up and cool cloth applied to face and neck. Felt cooler and said she has a hx of cyclic nausea/vomiting. She was resting and cool cloth applied again to face. Sipped some water. After total of 40 minutes of observation, patient felt better and declined further evaluation in the ED.
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| 45 | 2021-02-07 | abdominal discomfort |
1/29/2021 at apx 5:00am patient stated to have an upset stomach. Later in the day at apx. 12:00pm pa...
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1/29/2021 at apx 5:00am patient stated to have an upset stomach. Later in the day at apx. 12:00pm patient stated to have a fever of 102.0 F and beginning of a rash throughout her body. Symptoms continued through the following day. 1/31/2021 at apx 5:00am patient stated to have swelling of her throat and went to the emergency room. Patient given IV and gastrointestinal cocktail. Patient sent home steroid and diphenhydramine prescription.
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| 45 | 2021-02-07 | nausea |
Client reports had tingling in back of throat and tongue, took a Benadryl and symptoms subsided. Cl...
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Client reports had tingling in back of throat and tongue, took a Benadryl and symptoms subsided. Client reports taking Benadryl all evening long. Client reports 3 days later having migraines, nausea, head ache and not feeling well. Day 3 pulse dropped in the 40's which is abnormal. Denies trouble breathing. Client reports had similar symptoms of migraines but not additional symptoms.
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| 45 | 2021-02-07 | nausea |
Pfizer-BioNTech COVID19 Vaccine Severe symptoms following day: injection site pain, fatigue, headac...
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Pfizer-BioNTech COVID19 Vaccine Severe symptoms following day: injection site pain, fatigue, headache, whole body muscle pain, chills, nausea, malaise. 2nd and 3rd day symptoms: left underarm swollen lymph nodes, injection site pain, headache, tiredness, slight nausea, slight muscle pain. Missed work 1 day, unable to drive 2 days.
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| 45 | 2021-02-07 | nausea |
Severe headache; Fevers; nausea; body aches; severe prolonged fatigue; swollen underarms; This is a ...
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Severe headache; Fevers; nausea; body aches; severe prolonged fatigue; swollen underarms; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the second dose of BNT162B2 (lot number: EL1283 and expiry date was unknown), via an unspecified route of administration in the left arm on 10Jan2021 08:30 at single dose for Covid-19 immunization. The patient is not pregnant. Medical history included asthma. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (lot no. and expiry date were unknown) in the left arm on 21Dec2020 12:00 PM for Covid-19 immunization. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Jan2021 at 08:30 AM, the patient experienced severe headache for 12 days, nausea, body aches, severe prolonged fatigue, swollen underarms, fever for 7 days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included fluids and analgesics round the clock. The patient underwent laboratory test which included Covsars2 swab/nasal swab on 13Jan2021 and the result was negative. The events recovered with sequelae.
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| 45 | 2021-02-08 | difficulty swallowing |
faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arriva...
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faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arrival and it was 141/93; chills; low grade fever 100 degrees; This is a spontaneous report from a contactable 45-year-old female other health professional reported for herself that she received 1st dose of bnt162b2 (lot number EL8982) on 15Jan2021 08:00 AM at left arm for Covid-19 immunization. Medical history included hereditary angioedema from unknown date (last episode 2015). The patient had not received other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant drug included caffeine, paracetamol (ACETAMINOPHEN AND CAFFEINE). The patient reported that after waiting the 15 minutes, she walked to her car, and started feeling off. She thought about sitting in the hospital parking lot, but started to drive home. She started to feel dizzy, light headed, faint, dry mouth, hard to swallow so she drove herself to the fire station. They took her blood pressure (BP) upon arrival and it was 141/93 and blood sugar was 90 on 15Jan2021. She was 120 pounds and her normal BP was 116/63. The event onset time was reported as 15Jan2021 08:30 AM. Later on 15Jan2021, the patient had chills and low grade fever 100 degrees. Treatment was received for the events. The events were resolved on unknown date. Events were reported non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-02-09 | vomiting |
FOR THREE DAYS COULD NOT LIFT MY HEAD WITHOUT VOMITING, HAD A COUGH AND FATIGUE. WENT TO A WALK IN C...
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FOR THREE DAYS COULD NOT LIFT MY HEAD WITHOUT VOMITING, HAD A COUGH AND FATIGUE. WENT TO A WALK IN CLINIC ON DAY 4 ENDED UP GETTING COVID SWABBED AND IT WAS NEGATIVE AND TOLD TO REST AND DRINK FLUIDS. HERE IT IS DAY 20 AND I AM STILL COUGHING NON STOP AND VERY FATIGUED BY AFTERNOON I JUST NEED TO REST. I AM USING MY RESCUE INHALER FREQUENTLY DURING THE DAY AND ALSO USING MY MAINTENANCE INHALER WITH MINIMAL RELIEF. MY BACK ALSO HURTS IN MY SHOULD BLADES AND FEELS LIKE SOMEONE HAS PUNCHED ME.
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| 45 | 2021-02-10 | nausea |
Fever, cough, congestion, nausea, fatigue, headache, MS flare, hospitalized for MS flare, received h...
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Fever, cough, congestion, nausea, fatigue, headache, MS flare, hospitalized for MS flare, received high dose steroids for MS flare (4 days)
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| 45 | 2021-02-14 | decreased appetite, nausea |
nausea; Inappetence; fatigue; headache; brief chills; This is a spontaneous report from a contactabl...
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nausea; Inappetence; fatigue; headache; brief chills; This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 26Jan2021 at 10:30 AM as a single dose for COVID-19 immunisation, lot number: EL3247. Medical history was reported as none. Patient had no allergies to medications, food, or other products. Concomitant medications in two weeks prior to the vaccination included atorvastatin (LIPITOR), sertraline hydrochloride (ZOLOFT), fish oil, multi-vitamin. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 27Jan2021 at 06:30PM patient experienced nausea, inappetance, fatigue, headache, brief chills. No treatment received for the events. Since the vaccination patient had not been tested for COVID-19. Patient recovered from the events on unknown date.
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| 45 | 2021-02-14 | vomiting |
passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of ba...
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passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of back/torso, legs ached; tingling/severe pain shoulders and all of back/torso, legs ached; pain all over/torso; slight head ache; chills/cold; chills/cold; turned to temp 99.9; very warm/uncomfortable; fatigue; This is a spontaneous report from a non-contactable nurse (patient). This 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3249), via an unspecified route of administration on 29Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. The patient's concomitant medications included naproxen (occasional) in two weeks. The patient previously took first dose of bnt162b2 (Lot number: EK9231), on 07Jan2021 at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine received in four weeks. Patient got vaccine at 9:30am. Woke up morning (30Jan2021) after the vaccine about 9:30am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then paracetamol (TYLENOL) mid day. That evening had fatigue and pain all over, slight head ache, chills/cold and then turned to temp 99.9, very warm/uncomfortable. Paracetamol again that night before bed. Woke on Sunday better just fatigue and achy. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovered in 2021. No follow-up attempts are possible. No further information is expected.
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| 45 | 2021-02-14 | nausea, abdominal discomfort |
stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like n...
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stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like nausea; tongue was tingling a little bit; whole body was tingling; headache; her tongue feels like it is tingling and dry; has pain in her right hand since she got the vaccine dose in her right upper arm; feeling a little bit febrile, her temperature was 99 degrees Fahrenheit; This is a spontaneous report from contactable consumers. A 45-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EC1283, via an unspecified route of administration in the right arm, on 24Jan2021 17:00 at SINGLE DOSE for covid-19 immunization. Medical history included blood pressure, and on birth control. She recently started taking the blood pressure medication (lisinopril) three months ago her blood pressure was due to a lot of stress, and she was not feeling good she had her doctor to see her blood pressure her doctor then put her on this (lisinopril). She stated that she took Lisinopril 5mg at night last night as well as took her birth control pill. Concomitant medication included lisinopril for blood pressure; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), pantoprazole and an unspecified flu shot injection to arm in October (year not specified; she takes the flu shot every year). The patient received BNT162B2 on an unspecified date for covid-19 immunization; on the first dose of COVID-19 vaccine, she felt nothing, just a little tired and she had pain in her left hand. However, it was different for the second dose. Fifteen (15) minutes after getting her second dose of vaccine, the patient was fine. Then after 30 minutes, she came home and felt like her whole body was tingling, and her tongue was tingling a little bit. She says she did drink some water. She did no treatment other than drink some water and take and hold breath in and out, holding her breath a little bit. She says her body was tingling for just a second, that is gone, her tongue feels like it is tingling and dry, kind of like when you taste something spicy a little bit, that kind of experience. She says that it lasted like 1- 2 hours yesterday and it is not going, she still feels it a little bit on her tongue, the rest of her body is not tingling. She also experienced headache and has pain in her right hand since she got the vaccine dose in her right upper arm. Today(25Jan2021), she was feeling very tired, her heart rate was a little higher, like 95, and she was feeling something like nausea, her stomach was a little upset today, and she was feeling a little bit febrile, her temperature was 99 degrees Fahrenheit when she took it. Outcome of events was reported as 'unknown'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
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| 45 | 2021-02-16 | nausea, vomiting |
Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a co...
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Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 45-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 45-year-old) on 13Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included penicillin allergy. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 16Jan2021 at 06:00 PM patient experienced nausea, vomiting, shortness of breath, fainting and hand spasms. Events resulted in Emergency room/department or urgent care. Patient was treated at emergency room (ER) with diphenhydramine hydrochloride (BENADRYL), Steroid and Anti nausea. Patient was not tested for Covid post vaccination. Patient recovered on unknown date in 2021 from the reported events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-02-17 | abdominal pain, nausea |
Abdominal pain; severe nausea; headache; numbness in hand; itching on body on the side on injection;...
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Abdominal pain; severe nausea; headache; numbness in hand; itching on body on the side on injection; itching on body on the side on injection; dizziness; insomnia; night sweats; low grade fever; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown, unable to locate or read details), via an unspecified route of administration on 23Jan2021 16:15 (04:15 PM) at single dose on right arm for COVID-19 immunization. Patient was not pregnant at the time of report. The patient medical history was not reported. Patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications included fluticasone, salmeterol, montelukast and paracetamol (TYLENOL). Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The most recent COVID-19 vaccine was administered in School or Student Health Clinic The patient experienced abdominal pain, severe nausea, headache, numbness in hand, itching on body on the side on injection, dizziness, insomnia, night sweats, low grade fever, all on 24Jan2021 02:00. No treatment was received for the events. The events were assessed as non-serious. Outcome of the events was recovering. Patient has not been tested with COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 45 | 2021-02-21 | nausea |
Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-da...
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Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-day 3. Chills-day 4.
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| 45 | 2021-02-22 | nausea | Nausea, vertigo, ataxia, falls, change in vision persisting currently |
| 45 | 2021-02-22 | nausea | fever, chills, joint pain, nausea, headache, overall pain, insomnia |
| 45 | 2021-02-23 | vomiting, nausea |
Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated bloo...
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Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature. Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-02-23 | vomiting, nausea |
headache, flushing, nausea , vomiting and chest pain after 2nd dose. vitals were stable with stron...
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headache, flushing, nausea , vomiting and chest pain after 2nd dose. vitals were stable with strong pulses pt took zofran that she brought home. encouraged rest, and fluids. provided cold compress and reassurance pt laid down in a stretcher and rested for about an hour before getting discharged home.
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| 45 | 2021-02-24 | vomiting | Since the vaccine, headache, sore throat, vomiting and chills |
| 45 | 2021-02-24 | diarrhea, indigestion |
starting that evening, I had fever to 101, headache, heartburn and diarrhea for about 30 hours. on ...
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starting that evening, I had fever to 101, headache, heartburn and diarrhea for about 30 hours. on 2/25 I had an echocardiogram that had been scheduled 3 months prior. It showed a trace pericardial effusion which was unexpected.
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| 45 | 2021-02-25 | diarrhea, decreased appetite, vomiting |
Diarrhea, vomiting , Fever , chills, Extreme body each , Migraine, light sensitivity, weakness, Runn...
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Diarrhea, vomiting , Fever , chills, Extreme body each , Migraine, light sensitivity, weakness, Runny noise, lose of apatite . Extreme sweating. Extreme sweating of the under arm is still and issue. No fever now.
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| 45 | 2021-02-25 | nausea |
The patient presents with symptoms that started immediately after pt received her first covid vaccin...
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The patient presents with symptoms that started immediately after pt received her first covid vaccine around 1000 today at center. she developed lightheadedness, sob, nausea, h/a, and when er triage nurse was triaging her she syncopized for 3-4 seconds. no fall. pt was seated. and pt also reports that earlier she felt like the room was spinning. Tx in the ED w zofran and discharged.
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| 45 | 2021-02-26 | diarrhea, abdominal pain |
Blood pressure 65/33. Severe Diarreaha, moderate abdominal cramps, severe dizziness, close to fainti...
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Blood pressure 65/33. Severe Diarreaha, moderate abdominal cramps, severe dizziness, close to fainting. Minor chest pressure
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| 45 | 2021-02-27 | nausea | Headache, nausea, extreme fatigue, swollen glands, muscle aches |
| 45 | 2021-02-28 | diarrhea, nausea, vomiting |
Constricted throat. I was given Zyrtec. Observed for an hour. Got discharged. Throat constriction di...
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Constricted throat. I was given Zyrtec. Observed for an hour. Got discharged. Throat constriction didn't go away until 2 hours afterwards. Puffy, itchy eyes (both eyes) with rash came and lasted about two weeks. Monday or Tuesday, I noticed a rash all over my body - red and blotchy. That went away in a day. I got chills, fever, weakness, nausea, vomiting, diarrhea and that lasted 48 hours (16th in pm-17th and got better evening of 18th). When I had the rash was all over the body, I took a Zyrtec. The weekend I was really sick I didn't take any medication. Phone visit with Doctor - January 15th - allergist - I followed up with him about the throat constriction. He just was monitoring symptoms. After the weekend that I was really sick, I told him and he ordered bloodwork.
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| 45 | 2021-02-28 | nausea |
Fatigue; chills; severe aches; headache; nausea; dizziness; This is a spontaneous report from a cont...
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Fatigue; chills; severe aches; headache; nausea; dizziness; This is a spontaneous report from a contactable other healthcare professional. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, lot number: El9262, via an unspecified route of administration on 26Jan2021 15:00 at single dose in the left arm for COVID-19 immunization. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: En1686 on 05Jan2021 15:15 in the left arm. Medical history included allergy to bacteria. Concomitant medication included hydrochlorothiazide, triamterene (MAXZIDE), bupropion, escitalopram oxalate (LEXAPRO), lorazepam and paracetamol (TYLENOL). The patient previously took erythromycin and experienced drug allergies. The patient experienced fatigue, chills, severe aches, everywhere, headache, nausea, dizziness on 26Jan2021 at 22:00. No treatment received for the events. The patient had no prior vaccinations and has not tested for COVID post vaccination. The outcome of the events was not recovered.
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| 45 | 2021-02-28 | nausea |
Vasovagal Near Syncope Lightheadedness, Hypotension, Nausea Patient is a 45-year-old female wi...
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Vasovagal Near Syncope Lightheadedness, Hypotension, Nausea Patient is a 45-year-old female with history of hypertension, anxiety. Patient received vaccination at 14: 05, approximately 5 minutes later at 14:10, Vasovagal response
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| 45 | 2021-02-28 | vomiting, nausea |
after having the fever of 102, fainting and throwing up I had horrible vertigo and nausea. had to g...
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after having the fever of 102, fainting and throwing up I had horrible vertigo and nausea. had to go on anti vert and anti nausea meds, now 1 month later, I am still dizzy in the morning, my muscles ache terrible , especially my lower leg muscles , joint pain, and I am so exhausted
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| 45 | 2021-02-28 | nausea |
pain and swelling at the site, low fever, chills for several days, tiredness, constant headache. To...
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pain and swelling at the site, low fever, chills for several days, tiredness, constant headache. Tonight, end of day 3, injection site is warm/hot, raised, red and swollen. feelings of nausea intermittently today.
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| 45 | 2021-03-02 | appendicitis, abdominal pain |
severe abdominal pain; low grade fever; body chills; had an appendectomy at the ER; This is a sponta...
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severe abdominal pain; low grade fever; body chills; had an appendectomy at the ER; This is a spontaneous report from a contactable consumer (patient). This 45-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EN5318), via an unspecified route of administration on 11Feb2021 15:00 at single dose in the right arm for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included magnesium, cannabidiol (CBD) and docusate sodium (COLACE) received within 2 weeks of vaccination. The patient previously took the first dose of bnt162b2 (lot number=EL1283) on 21Jan2021 15:00 in the left arm for COVID-19 immunization and experienced extreme muscle cramps in both legs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. On 13Feb2021 19:00, patient experienced severe abdominal pain with a low grade fever and body chills. Patient visited her primary doctor the following day, and then went to the ER on day four of the onset of her symptoms. Patient had an appendectomy in Feb2021 at the ER. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included surgery to remove appendix. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab (post vaccination): Negative on 15Feb2021 and 16Feb2021. Outcome of the events was recovering. The report was assessed as serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021183649 same patient, different AE/dose
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| 45 | 2021-03-03 | nausea |
Report couldn't breath, couldn't stand up or walk. Stated started to black out, fever 102.0, chills...
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Report couldn't breath, couldn't stand up or walk. Stated started to black out, fever 102.0, chills and nausea. Treatment: nothing Outcome: Continue to be short of breath with walking, body aches improved. Advise to see her PCP or seek urgent or emergent care if become SOB.
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| 45 | 2021-03-03 | difficulty swallowing | Reported difficulty swallowing |
| 45 | 2021-03-04 | abdominal discomfort |
Instantly had a Metal taste in mouth and buzzing tongue. Later I had a very sore arm and throat. The...
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Instantly had a Metal taste in mouth and buzzing tongue. Later I had a very sore arm and throat. Then the next day I had a headache, upset stomach, chills and a was achy.
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| 45 | 2021-03-24 | nausea |
Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine...
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Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Fever; Body aches; She felt like she was going to die; feels awful; Constipation; Couldn't keep her eyes open; Chills; Sore arm; Tired; couldn't keep her eyes open; Nauseousness; Lightheaded; it felt like someone was playing with my head and controlling her memories; sugar levels going up; This is a spontaneous report from a contactable consumer (patient). This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6205 and expiration date 30Jun2021 received on 03Mar2021 as a single dose (at the age of 45 years), unspecified route in left arm for COVID-19 immunisation. History included thyroid removed in 2014 and diabetes in 2019 (diagnosed about a year and a half ago), Cirrhosis liver, fatty liver. Concomitant medications include metformin for diabetes, glyburide for diabetes, levothyroxine sodium (TIROSINT) for thyroid disorder, cetirizine hydrochloride (ZYRTEC), omeprazole, ascorbic acid (VITAMIN C), zinc, ergocalciferol (VITAMIN D), bifidobacterium lactis (PROBIOTIC), fluticasone propionate (FLONASE), albuterol (SALBUTAMOL), and budesonide, formoterol fumarate (SYMBICORT). Following the vaccination on 03Mar2021, she came home at night with sore arm and started getting chills. She felt very nauseous. She could not open her eyes anymore. She went to sleep and woke up in the middle of the night. She felt like someone was controlling her memories. It felt like someone is taking away memories (Mar2021) and she was trying to hold on. Like something was messed up in her head. The next day she woke up with a sore arm and felt fine. She had a little nauseousness but it was controlled. On Friday (04Mar2021), the vaccine site became red, hot, hard, and had a white ring around it. The more red it became the more fever, nauseousness, and constipation she had. She couldn't keep her eyes open. She started coughing. She had to use her inhalers even more. Her inhalers are Albuterol and Symbicort and she doesn't have a lot number to provide for her inhalers. All day she felt that way. She felt like she was going to die, has body aches. It was awful. She also had dizziness at nighttime she took the ice pack and froze her arm because she couldn't take it anymore. Saturday, 05Mar2021 she woke and still had dizziness and couldn't go to the bathroom. She feels nauseous. She can't keep her eyes open. Sunday (06Mar2021) it was better (unspecified events), but she is not herself. Ever since then she feels like she is always tired. Today it has been a week after and she is so tired. She called the number and one of the representatives said she wouldn't do the second dose. The doctor said it is side effect. She also reported that she is lightheaded. She said her sugar numbers have been sky high. She told the nurse that it didn't hurt like the flu shot. She did not have NDC, lot, and expiry to provide for flu shot. Lab information in Mar2021 included Sugar levels were up and weight: 203 to 205 pounds. Outcome of events was unknown.
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| 45 | 2021-03-24 | abdominal discomfort, diarrhea |
Instant Lupus flare; Instant extremely high blood pressure and pulse rate; Instant extremely high bl...
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Instant Lupus flare; Instant extremely high blood pressure and pulse rate; Instant extremely high blood pressure and pulse rate; Instant red face; tightness in chest/Instant hot fire feeling in stomach and chest.; Instant hot fire feeling in stomach and chest; Shortness of breath; Sore throat; diarrhea; upper back pain; Tiredness; rash on arm; chills; insomnia; This is a spontaneous report from a contactable consumer. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 08:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included lupus, high blood pressure, asthma, anemia. No pregnant. No covid prior vaccination. No known allergies. No other vaccine in four weeks. Other medications in two weeks. The patient's concomitant medications were not reported. The patient experienced instant lupus flare, instant extremely high blood pressure and pulse rate, instant hot fire feeling in stomach and chest, instant red face, shortness of breath, tightness in chest, sore throat, diarrhea, upper back pain, tiredness, rash on arm, chills, insomnia on 18Mar2021 08:15 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: instant extremely high, blood pressure measurement: instant extremely high, sars-cov-2 test(Nasal Swab): negative on 07Jul2020, on 11Nov2020, on 15Dec2020, on 01Feb2021. Treatment received as Emergency care and needed extra bp and Lupus meds. The patient experienced Emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Information on the Lot/Batch number has been requested.
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| 45 | 2021-04-08 | abdominal pain upper |
Headache, stomach pain, chills, tiredness, general body ache. Rash on the skin (the itch lasted more...
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Headache, stomach pain, chills, tiredness, general body ache. Rash on the skin (the itch lasted more than a week). Since the vaccine I have felt inflammations in the body in general.
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| 45 | 2021-04-21 | nausea | Nausea, headache, body ache, fatigue, fever up to 102.5 degrees F |
| 45 | 2021-04-24 | nausea, vomiting |
is passing out at 7PM; had two antibody tests and she's been negative; Patient verifies she is not d...
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is passing out at 7PM; had two antibody tests and she's been negative; Patient verifies she is not dizzy, she just feels like yuck; Patient states she has pain; she felt like she couldn't breathe; she felt like, not herself, like un-well. Patient states she is feeling unwell since; zapping, basically like a electric shock; nausea and vomiting; nausea and vomiting; extreme fatigue/that night she was exhausted, she couldn't pick up her head; head just doesn't feel right/she couldn't pick up her head; fever; closing of her throat; heat coursing through her body, felt heat in her vessels/she was a bloody, hot mess; chills; This is a spontaneous report from a contactable other health professional. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:00 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunization. Patient states she had chronic strep throat, she was sick four times a year for the first 12 years of her life. Patient stated she has no allergies, she was a healthy woman. Concomitant medication included simvastatin taken for an unspecified indication from 2020 and ongoing. On 26Mar2021, the patient experienced nausea/vomiting happened almost immediately, soon after the injection. The patient stated she wasn't feeling well, she had to go home from work, but the symptoms started that day almost immediately and persisted for a few days later. She has this zapping. The patient stated it was actually a term, it's basically like an electric shock that she was feeling throughout her body, like from head to toe on 08Apr2021. The patient stated and her head just doesn't feel right, just like dizziness. The patient stated she has pain and was uncomfortable. Patient stated she was concerned about what to do moving forward. Patient stated the day she got the shot, within three minutes, she felt like she couldn't breathe. Patient stated it was not emotional, she's very self aware, she was a psychologist. Patient stated it was a closing of her throat, but that has turned on and off as well. Patient stated then she had heat coursing through her body, felt heat in her vessels, down the center of her throat down in to her throat into the center chest and down into legs. Patient stated that night she was exhausted, she couldn't pick up her head. Patient stated she threw up and had chills, she felt like, not herself, like un-well. Patient states she was feeling unwell since. Patient states she did travel that Monday after, which she doesn't know if it made it worse, but was gone only for an hour, then got sick again that night with fever and throwing up. Patient states then yesterday, she started getting these zaps in her body, it felt like someone had put a taser to her all over her body. Patient stated she was just not herself, she wasn't at her normal. Patient stated she passed out at 7PM at night. Patient verified she was not dizzy, she just felt like yuck. Patient stated she also experienced chills and fever, that happened later that day on 26Mar2021. Patient stated she came back to work and she just felt like she needed to go home. She was instantly not well. Patient stated she has had two antibody tests and she's been negative. Patient stated she checked after that, she made sure she had no antibodies. Patient clarified she checked her antibodies twice before getting the vaccine. Patient stated her resting heart rate was at 55, she was in athletic shape, she was healthy. Patient stated when she had the both, she was on the toilet and throwing up at the same time, she was a bloody, hot mess. Patient states she ripped her clothes off, she was hot. The outcome of the event nausea, vomiting, fatigue, "head just doesn't feel right" was recovered with sequel on 03Apr2021l; fever was recovered with sequel on 07Apr2021; chill was recovered on 03Apr2021; electric shock was not recovered and unknown for the other events. The patient did not received any recent vaccines for SARS-COV2 other than Pfizer- BioNtech COVID-19 Vaccine prior to the event being report and has not received any other vaccines around the time of Pfizer- BioNTech Vaccine Vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-01-01 | diarrhea |
Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driv...
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Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driving due to violent rigors. Single episode explosive diarrhea upon arrival home. Patient incapacitated on couch for 3.5 hours due to shaking chills, dizziness, headache, profound weakness, near syncope when attempting to get up. Patient unable to reach phone to summon help for over an hour. (phone was only 2 feet from patient).
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| 46 | 2021-01-04 | difficulty swallowing |
Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her ...
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Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her own albuterol inhaler without relief. Transported to ED. PE: red hands with swelling, throat and lip swelling with difficulty swallowing. Later developed headache and dizziness then tachypnea and stridor. Meds given - See section 5 PLUS epinephrine IM and infusion @ 0.05 mcg/kg/min, Alb and ipratropium negs, racemic epi nebs. Admitted to the hospital on 12/22 and still hospitalized at the time of this report on 12/23. She remains on an epinephrine drip and was given methylprednisolone 125 mg IV x 2. No previous history of anaphylaxis. History of Reye's syndrome as a child when given aspirin.
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| 46 | 2021-01-04 | abdominal pain |
At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen an...
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At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen and tried to go to sleep. I was unable to sleep on my left side as normal. Around 12:30am I woke up cold, shivering violently, with a fever of 103.°3. My feet were also burning. I woke up around 2:30am. Fever was down to about 102.4°, feet were still burning and my face and eyes were swollen. I took more ibuprofen and put used cold compress on my eyes. Around 4:30am I woke up with abdominal pain and pain in my hips. Fever was lower, eyes were better but face still swollen and feet still burning. I called off work at that time. By about 8am fever broke and have just had an intense headache.
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| 46 | 2021-01-04 | nausea |
Began with headache in late evening on the 4th. Woke up with extreme nausea, headache, fatigue. Ha...
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Began with headache in late evening on the 4th. Woke up with extreme nausea, headache, fatigue. Has continued through the day of 5th.
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| 46 | 2021-01-04 | abdominal pain | Muscle aches followed by severe abdominal cramping |
| 46 | 2021-01-04 | nausea |
Never pregnant, swelling and redness at injection site, Nausea in the morning, slight fever, no brea...
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Never pregnant, swelling and redness at injection site, Nausea in the morning, slight fever, no breathing difficulties, and weakness. Tylenol helped.
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| 46 | 2021-01-04 | nausea |
feeling like motion sickness, light headed/unbalanced which is causing nausea, when in sitting posit...
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feeling like motion sickness, light headed/unbalanced which is causing nausea, when in sitting position on couch i feel fine. too much movement gets me nausea and feeling light headed
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| 46 | 2021-01-04 | nausea | nausea, numbness & tingling of mouth/tongue |
| 46 | 2021-01-04 | nausea |
severe intractable headache; photo sensitivity; generalised body malaise; pain & tenderness in injec...
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severe intractable headache; photo sensitivity; generalised body malaise; pain & tenderness in injection site; nausea; This is a spontaneous report from a contactable physician. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 23Dec2020 01:00AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. The patient medical history was not reported. Concomitant medication included folic acid, ascorbic acid (VIT C), tocopherol (VITAMIN E), Multivitamins. The patient previously took metronidazole and experienced drug allergy, NTG and experienced drug allergy. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe intractable headache, photo sensitivity, generalised body malaise, pain & tenderness in injection site, nausea on 23Dec2020 12:00 PM. Patient received Tylenol, neurofen and rest as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The events were reported as non-serious.
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| 46 | 2021-01-05 | nausea, abdominal pain upper |
About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever a...
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About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever and some chills, along with body aches. I felt nauseous. I started feeling cramping in my stomach. Yesterday, my temp was just 99.4, face was really red. Felt over heated all day long. When they gave me the shot, after 20 mins I could feel my right nostril burning, and like I could taste a metal taste and taste the actual shot. At 9am, my temp was 100. I took a tylenol.
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| 46 | 2021-01-05 | nausea |
Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of ...
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Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of right toe. Blood pressure and heart rate mildly elevated beginning around 10:40 pm 1/5/21. Spoke with a triage nurse twice late pm 1/5/21 and early am 1/6/21. Advised self monitoring. Unable to sleep more than about 1 hr at a time-woke up sweaty. No temp. Woke up without dizziness/nausea but had dizziness when eating cereal and looked down. Saw general practice physician 1/6/21 after 10 am 1/6/21. Given anti-dizziness med. prescription. Dizziness/nausea, Tired/heaviness in legs gone when saw physician. Still mild altered sensation in right leg and big toe numbness that comes and goes. Elevated blood pressure at physician. Bloodwork ordered and scheduled for Saturday.
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| 46 | 2021-01-05 | nausea | Extreme fatigue and nausea. |
| 46 | 2021-01-05 | nausea |
Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not ...
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Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not even move; Different waves of chills to the point of she could not even move; sweating; severe headache; just crap now; Now she smells metal; she has no sense of smell other than stinky metallic smell; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right deltoid on 30Dec2020 08:15 at a single dose for vaccination. The patient's medical history included tested positive for COVID-19 from Jul2020. There were no concomitant medications. Around 30Dec2020 9:00 AM, she began experiencing extreme nausea and dizziness, extreme fatigue, different waves of chills to the point of she could not even move, sweating, severe headache, and just crap now. The patient's physician told that this is something she should report. It could possibly have been an immune response because she had possibly been exposed to COVID-19 that she probably had some sort of antibodies from then until now on Dec2020, even though she tested negative for COVID-19 and continued to test negative for COVID-19 on 2020. She smells metal on Dec2020. She has no sense of smell other than stinky metallic smell. Her taste is fine. Outcome of the headache was not recovered, of the metallic smell was unknown, of the remaining events was recovered on 30Dec2020 13:00.
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| 46 | 2021-01-05 | vomiting, nausea | Headache, Myalgia, Arthralgia, NauseaVomiting, chills/ pain inj site |
| 46 | 2021-01-05 | nausea |
muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; he...
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muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; headache; Nausea; left arm numbness; left arm tingling; left hand numbness/left side of face and head numb; left hand tingling; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), intramuscular on 30Dec2020 04:45 at single dose at left deltoid as Covid vaccine for coronavirus. Medical history was none. There were no concomitant medications. The patient stated that she had Covid vaccine. She had dizziness, headache, nausea, left arm hand numbness and tingling, feels very weak, left side of face and head numb, all on 30Dec2020, neck pain and feeling tired, muscle aches, eyes watering and won't stop, eyes hurt in the morning, all on 31Dec2020. Treatment was None. Headache, eyes watering and won't stop, feels very weak and tired, eyes hurt was reported as worsened. Outcome of Nausea, left arm numbness was recovering, of other events were not recovered.
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| 46 | 2021-01-06 | nausea, decreased appetite |
Chills, fever, extreme body aches, nausea Ibuprofen 400mg taken every 4-6 hours. Fever broke after ...
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Chills, fever, extreme body aches, nausea Ibuprofen 400mg taken every 4-6 hours. Fever broke after 15 hours but returned within 4-6 hours. Easier to manage on second day with ibuprofen. Loss of appetite and nausea. Compazine taken forever nausea. Currently 50 hours post vaccination, had to miss work due to symptoms. Fever free for 12 hours , co tinge to have loss of appetite and body aches
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| 46 | 2021-01-06 | nausea |
Day 1: strong ache in all joints, mild nausea, headache Day 2: swollen lymph nodes in left arm & nec...
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Day 1: strong ache in all joints, mild nausea, headache Day 2: swollen lymph nodes in left arm & neck, severe back ache low temp 99-100.3 Day 3: @ 0300 fever 101.5, chills (rigors 3hrs), very bad headache, neck pain, joints and lymph swelling. Had both regular and Rapid covid test and rapid was negative. Awaiting FLU swab and regular Covid test. Day 4: continued fevers 99-100.9, back and neck pain, milder headache.
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| 46 | 2021-01-06 | nausea | Fever 36-48 hours Headache Chills Nausea Aches/ sore muscles |
| 46 | 2021-01-06 | abdominal pain |
I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on...
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I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on the 3rd and 4th day, I had chest pain radiating to left arm and jaw. Fever and chills reported 100.2 in fever. Severe right arm pain. I have difficulty lifting objects. I have recovered from the chest pain and abdominal pain but the arm pain is still bothersome and continues to be hurtful.
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| 46 | 2021-01-06 | nausea |
Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortnes...
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Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortness of breath, left axillary lymphadenopathy, elevated blood pressure which onset on 12/31. COVID-flu negative, normal labs, CT thorax and brain MRI negative. Has been to ED and is returning today due to continued symptoms. Reported symptoms to VSafe
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| 46 | 2021-01-06 | nausea, vomiting |
Presented to ER 12/23/2020 with Lightheadedness, chills, nausea, vomiting, rash. Iv fluids and antie...
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Presented to ER 12/23/2020 with Lightheadedness, chills, nausea, vomiting, rash. Iv fluids and antiemetics administered, pt reported feeling better. RX for Medrol Dosepak given.
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| 46 | 2021-01-06 | nausea | Sore arm- lasted 3 days. Moderate intensity Fatigue- 24 hours Nausea and dizziness-2 hours |
| 46 | 2021-01-06 | nausea, vomiting |
Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin ...
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Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin pale, diaphoretic, c/o nausea with vomiting x1. Taken to ED. Treated with Benadryl 50mg IV, Zofran 4mg SL, meclizine 25mg PO, and 1 liter of 0.9% Normal Saline IV. Symptoms improved, discharged to home at 6pm.
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| 46 | 2021-01-06 | nausea | nausea, fever, body chills,headache, tx with Motrin |
| 46 | 2021-01-07 | decreased appetite |
With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I co...
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With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I couldn't get warm, I felt very tired. About the next thirty hours I had body ache and head ache my arm got very heavy and hurt, I did not run a fever but felt very restless and achy. I was very tired and didn't work the following day, didn't have much of an appetite. I had some mild itching on my arm.
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| 46 | 2021-01-07 | difficulty swallowing |
difficulty breathing/swallowing; difficulty breathing/swallowing; Hives/hives all over including in ...
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difficulty breathing/swallowing; difficulty breathing/swallowing; Hives/hives all over including in her mouth; This is a spontaneous report from a contactable consumer (spouse). A 46-year-old female patient (wife) received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, lot number: EH9899) via unspecified route of administration at arm right on 29Dec2020 at single dose for Covid-19 vaccine. Medical history included ongoing anxiety diagnosed 22 years ago. Concomitant medications were not none. Patient received the vaccine and was one big hive (01Jan2021). She went to the ER on sat and will have to go back. Caller is asking where she should go. patient went through the VAERS report 3 times. She did not have any sides effects. patient is a frontline worker. On 29Dec2020 she got the Covid vaccine. On Sat 02Jan2021 she went the ER with hives all over including in her mouth, stated she had difficulty breathing/swallowing, was given medication to take home and discharged. She was readmitted yesterday 05Jan2020 with worsening symptoms and needed to be given a prednisone nebulizer. they had two ER visits. No Investigation Assessment. patient was not recovered from the event hives/hives all over including in her mouth, the final outcome of other events was unknown.
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| 46 | 2021-01-08 | decreased appetite | 1st Day- Arm Neck Pain 12/31/2020 Loss of Appetite, Dizzy-current |
| 46 | 2021-01-08 | nausea | Chills, Headache, Nausea, and Fever |
| 46 | 2021-01-08 | nausea, vomiting |
Dizziness, NauseaVomiting, right arm mild soreness Narrative: 12/29 employee reports onset of dizzi...
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Dizziness, NauseaVomiting, right arm mild soreness Narrative: 12/29 employee reports onset of dizziness and nausea about 2 hours after the vaccine. Her right arm is slightly sore. 12/30 - symptoms have improved and are very slight today. 12/21 resolution of all symptoms.
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| 46 | 2021-01-08 | vomiting, nausea |
Myalgia, NauseaVomiting, Left Arm pain, fatigue, sharp muscle pain, nausea Narrative: Rest, fluids,...
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Myalgia, NauseaVomiting, Left Arm pain, fatigue, sharp muscle pain, nausea Narrative: Rest, fluids, Tylenol and Motrin at home
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| 46 | 2021-01-09 | difficulty swallowing |
15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could fe...
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15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could feel my pulse escalating. Nurse in the post-shot monitoring tent took vitals to confirm pulse at 95, when typically 68. I was laid down and BP dropped to 110/78. Chest tightness that I am familiar with from asthma started to develop and my neck and throat and upper shoulders felt very tight and constricted. I had some trouble swallowing water as though my throat was constricted and my breathing felt shallow. Nurses provided care and I was asked to get up and sit in a chair again. Within a minute, I felt dizzy and disoriented again and heart rate went up. The tightness in my chest and throat and shallow breathing continued along with my voice becoming hoarse. The doctor on call asked if I?d had these symptoms before and I said I had after eating shrimp years ago. He decided to transfer me to the ER for monitoring . I stayed at the ER for about an hour and a half and was monitored. The constricted throat and asthma chest tightness did not subside but did not get worse. Doctor recommended Benadryl every 6 hours as symptoms persisted. Within a half hour of taking 25 mg of Benadryl, I started to feel improved breathing and less throat constriction and easier swallowing. After the second dose of Benadryl, symptoms were much 70% gone, except for hoarse voice abs very slight tightness with swallowing. I had informed the injection staff prior to receiving my vaccine that I am a person with a history of anaphylaxis (not to a vaccine) that required and epi pen and overnight hospital stay in the past .
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| 46 | 2021-01-09 | indigestion |
Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway con...
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Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway constriction but on the outside). Severe heartburn, burping and reflux, anxiety, slightly elevated heart rate about 30 mins after injection, lasting about 30 mins. 5 hours after injection, after eating a small snack, repeat of heartburn, burping and reflux. Felt hot but temperature 97.7, then chills briefly. Anxiety and related fast heart beat and shallow breathing for about 1 hour. Took benadryl, no change.
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| 46 | 2021-01-09 | nausea | mild nausea 12/25 and 12/26 |
| 46 | 2021-01-10 | vomiting |
01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vacci...
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01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vaccine 01/09 body aches, headache couldn?t move neck due to stiffness; 01/10 left arm soreness, armpit pulsation, fever range 102 F,; 01/11 vomiting. seasonal allergy eye drops for right eye swelling (went away), Benadryl 50 mg.; ibuprofen and Tylenol around the clock starting 01/09 to present day, 01/11/2021
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| 46 | 2021-01-10 | nausea, diarrhea |
About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: lik...
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About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: like felt like rushed through my body and then instantly my heart started racing and I felt it thump into my throat. Let nurse in attendance know and she took me to another area secluded from others and told me to relax. Sat down. Hooked me up to monitors; blood pressure cuff and finger pulse and she left to go get someone and she brought EMT back with her. Felt tight in chest; in neck felt like there's tightening; but could still breathe; felt heavy: chest. Neck felt tight. Felt like I needed an inhaler. I don't have it with me as I only have asthma in spring and fall. They kept telling me to calm down and I wasn't feeling nervous. I was trying to relax. EMT asked questions and he said that the same thing happened to him. He told me I couldn't leave Event Center until things calmed down for me. Released her when I felt fine but was just really tired and kind of shaky. I felt so exhausted. Told EMT that and he told me he would feel that way if he had just ran a marathon. I had slept 12 hours the night before. He didn't tell me what my heartrate went up to. I left event center at 9:49 pm. Started feeling strange again when doing errands and was at store afterwards (about 30 or 40 min later) - nauseous; dizzy; sweaty, clammy. Heart was racing again. I told husband I didn't feel right. Felt like I needed to sit because I was shaky. Left and went to vehicle. As we sat in car, I told him something wasn't feeling right. Mouth was so dry. He started driving. I felt like we were driving down a tunnel.Husband looked at me and said you don't look right either. Took me to ER in nearest hospital: blood pressure high; heart rate elevated; ER (Hospital) The doctor did lab work. Triponin levels elevated; potassium levels low - sign of a heart episode and needed to get in control. Gave me potassium and took more blood work and troponin levels started coming down. Dr advised me not to go back to get second dose. Personal Care Dr confirmed that I shouldn't get the 2nd dose - put in my records that I am allergic to this vaccine. The next day I had severe diarrhea and terrible pain in my arm that went all the way down and up into my neck and whole right side head hurt. (really bad headache). Extreme fatigue. Went back to work on the following Monday evening and was exhausted doing my job. When I say family Dr on Tuesday, I didn't want to be taken off work because I was in the right place where people could take care of me and I'd taken time off at holidays. That entire week was a lot of exhaustion and tiredness.
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| 46 | 2021-01-10 | diarrhea |
Diagnosed with COVID 19, Cough, Fatigue, Aguesia, Anosmia, Diarrhea, Headache, phonophobia, leg pain...
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Diagnosed with COVID 19, Cough, Fatigue, Aguesia, Anosmia, Diarrhea, Headache, phonophobia, leg pain. Patient now knows she was exposed before receiving vaccine.
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| 46 | 2021-01-10 | diarrhea |
Diarrhea beginning within 12 hours of receiving vaccine, treated w/hydration, no food, pepto bismol,...
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Diarrhea beginning within 12 hours of receiving vaccine, treated w/hydration, no food, pepto bismol, rest, no medical needed. Still ongoing >10 days out from vaccine, not as severe as initial onset, but returns as soon as pepto bismol has worn off.
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| 46 | 2021-01-10 | nausea |
Erytema with facial flushing on neck and face, Nauseas, no vomit, No dyspness, no shortness of brea...
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Erytema with facial flushing on neck and face, Nauseas, no vomit, No dyspness, no shortness of breath. treatment Benadryl IV = Solumedrol + Famatidine IV
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| 46 | 2021-01-10 | nausea | Fever, chills, nausea, headache |
| 46 | 2021-01-10 | abdominal discomfort, diarrhea |
Pfizer COVID-19 Vaccine A couple hours after the vaccination the patient experienced pain in the v...
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Pfizer COVID-19 Vaccine A couple hours after the vaccination the patient experienced pain in the vaccine arm, headache, and feeling ache. Day 1 post vaccination patient experienced sore arm, headache, low grade fever, feeling ache, and GI symptoms with diarrhea. Day 2 post vaccination patient experienced sore arm, Migraine, and diarrhea. Day 3 post vaccine patient woke up with chest pain that radiated into her left arm and some weakness. Patient's blood sugar was >500 and was admitted to hospital for DKA.
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| 46 | 2021-01-11 | abdominal discomfort, decreased appetite, abdominal pain, nausea |
1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-t...
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1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-took tylenol and benadryl 1/7/2021, 6:30 AM, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore, called into work 1/7/2021, 10:20 am, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore-took benadryl and tylenol 1/7/2021, 1:15 PM, very fatigue, fever, body aches, upset stomach, right ear throbbing, fever 100.6-employee health notified, was advised to self monitor for 48 hrs and if no improvement to be tested for COVID on 1/9/2021 1/7/2021, 7:27 PM, completely exhausted, on going headaches, chills off and on, body aches, decreased appetite-tylenol taken 1/8/2021, 10:02 AM, headache, body aches, arm swollen and very painful, the pain traveled to the armpit, felt about 60 % better this day, but still fatigue Symptoms remain the same for the day of 1/8/2021 1/9/2021, 9:38 AM, lingering headache, arm and armpit sore; otherwise, feel much better 1/10/2021, 7:27 PM, Felt much better this day, just little fatigue and arm soreness; otherwise not further symptoms.
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| 46 | 2021-01-11 | nausea, vomiting |
Day 1 After vaccination fatigue, Day two fatigue, nausea vomiting, afternoon started with bilateral ...
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Day 1 After vaccination fatigue, Day two fatigue, nausea vomiting, afternoon started with bilateral foot pain. Day three moderate bilateral foot pain, all joints have pain, hands and feet the worst. Day four: fatigue (decreased), all over joint pain mild to moderate (went home from work) fatigue. Day Five (today) continued bilateral feet and hand joints mild pain that increases with pressure (walking holding or opening anything causes increase in pain from mild to moderate.
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| 46 | 2021-01-12 | nausea |
01/12/2021 reported redness in face, neck, stomach, and minimal on arms. Swelling on eyelids, slight...
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01/12/2021 reported redness in face, neck, stomach, and minimal on arms. Swelling on eyelids, slightly nauseated. Instructed by employee health to take Benadryl STAT and report to ED for worsening symptoms. 01/13/2021 Pt reports symptoms are no longer present and has no complaints.
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| 46 | 2021-01-12 | vomiting |
Around 11:30pm on 1/12/2021, began having pretty serious chills (fever not measured but felt very wa...
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Around 11:30pm on 1/12/2021, began having pretty serious chills (fever not measured but felt very warm). At about 1:45am on 1/13/2021, was feeling very achy and uncomfortable, so I went downstairs to get some Tylenol. Rapid heart rate and sweating, so much I had to sit down in the kitchen for a few minutes. Eventually took the Tylenol, and as I was heading back upstairs, I passed out (I don't remember going down to the floor) and dropped the cup of water I was taking with me. Was out for less than 30 seconds. A couple episodes of heaving/vomiting small amounts of liquid while on the floor. Made it back to bed and was starting to feel improved around 4:00am.
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| 46 | 2021-01-12 | retching, vomiting |
Around 11:30pm, I woke up with incredible chills and had them for about 1.5 hours. Around 1:45am/2:0...
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Around 11:30pm, I woke up with incredible chills and had them for about 1.5 hours. Around 1:45am/2:00am on 1/13/2021, aches began, so I went downstairs to take acetaminophen. Increased heart rate and sweating while in the kitchen (had to sit down on the floor), eventually took Tylenol, and as I was heading back upstairs with cup of water, I passed out (less than 30 seconds) dropping the cup of water. Heaved/vomited small amount of liquid two or three times. Made it back to bed and began to feel better around 4:00am 1/13/2021.
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| 46 | 2021-01-12 | nausea |
Palpitations; Chest pressure; Lightheadedness; Nausea; This is a spontaneous report from a contactab...
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Palpitations; Chest pressure; Lightheadedness; Nausea; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Dec2020 14:15 at left arm, at single dose for covid-19 immunization. Medical history included history of seizure, known allergies: topical Sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included (ascorbic acid) (VITAMIN C), (sambucus nigra) (ELDERBERRY), (linum usitatissimum seed oil) (FLAXSEED OIL), (allium sativum) (GARLIC). The patient previously took lamotrigine (LAMICTAL) and known allergies: LAMICTAL. The patient was not pregnant at the time of vaccination. The patient experienced palpitations, chest pressure, lightheadedness and nausea on 23Dec2020 14:15. The patient received Zofran and Meclizine given. Event resulted in: Emergency room. The outcome of the events was recovered on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information on the lot/batch number has been requested.
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| 46 | 2021-01-12 | nausea | headache nausea syncope |
| 46 | 2021-01-13 | vomiting, nausea | Systemic: Nausea, Systemic: Vomiting, Systemic: shortness of breath |
| 46 | 2021-01-13 | decreased appetite |
fever above 100, Bone muscle pain on a scale 7/10, injection site pain and burning 9/10, dizzi...
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fever above 100, Bone muscle pain on a scale 7/10, injection site pain and burning 9/10, dizziness, slight headache and decreased appetite
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| 46 | 2021-01-13 | abdominal distension |
following initial vaccine 12/28, got extremely bloated with joint tightness, fluid overload, inflamm...
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following initial vaccine 12/28, got extremely bloated with joint tightness, fluid overload, inflammation, overall discomfort, back pain which radiated to the front of the chest lasting x3 days, took Tylenol. now resolved
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| 46 | 2021-01-13 | difficulty swallowing |
throat is swelled; hard for me to swallow; This is a spontaneous report from a contactable consumer ...
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throat is swelled; hard for me to swallow; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the Pfizer vaccine for the COVID-19 on 29Dec2020. She reported that it was hard for her to swallow on an unspecified date. It was not when she was eating or drinking, just sitting down. She was having trouble swallowing on an unspecified date. It felt like something in her throat swelled. She was having trouble swallowing. She works as a lab assistant. As for the treatment, she said that she has a doctor appointment on Monday (unspecified date). She had been taking diphenhydramine hcl (BENADRYL) as treatment. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 46 | 2021-01-14 | nausea, diarrhea, decreased appetite, vomiting |
I had body aches, knee joints were hurting, temp 100F, chills, shaking, exhausted like I was hit by ...
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I had body aches, knee joints were hurting, temp 100F, chills, shaking, exhausted like I was hit by a truck. Later that evening my temp went to 102F, after that I was sleeping 10 hours a day, no appetite, nausea, vomiting, diarrhea, 9lbs in 9 days, back was killing me, alternated hot and cold compress. One morning I woke up and my tongue was like a rock, I was so dehydrated. Fever for 5 days, took Tylenol and it would just break it down to 100F. Went to COVID and flu on the 12/29 got positive for COVID on 12/31/20. Yesterday I felt hot and flushed and was sweating profusely, other than that no other symptoms. ( I received the second dose on 01/13/21)
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| 46 | 2021-01-14 | vomiting, nausea |
Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and ...
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Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Tighten in chest; Weakness; dizziness; Slept for over 24 hours; Nausea; vomiting; This is a spontaneous report from a contactable other Health Professional (HCP) (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on 07Jan2021 14:30 at single dose in her left arm for covid-19 immunization. Medical history included dermatitis contact and asthma. The patient had allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) at single dose in her left arm on 17Dec2020 14:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced feft arm went total numb for over 72 hours, red and swollen all the way up to the shoulder, tighten in chest, weakness and dizziness, slept for over 24 hours, nausea and vomiting on 08Jan2021 04:30. The events result in doctor or other healthcare professional office/clinic visit. The patient received prednisone 100 mg to treat these events. The outcome of the events was recovered in Jan2021.
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| 46 | 2021-01-14 | nausea | Lightheaded, dizzy, nausea, dry mouth, shortness of breath |
| 46 | 2021-01-14 | nausea |
Low grade fever, muscle aches, fatigue, nausea, headache hours 17 - 29 post vaccine. Still continui...
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Low grade fever, muscle aches, fatigue, nausea, headache hours 17 - 29 post vaccine. Still continuing to have headache, as well as fatigue and shortness of breath with activity.
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| 46 | 2021-01-14 | vomiting | Temature, body aches, headache, weak and vomiting |
| 46 | 2021-01-14 | abdominal pain upper, nausea | headache, nausea, pain in upper stomach area |
| 46 | 2021-01-14 | nausea, diarrhea |
headache; chills; muscle & joint pain; muscle & joint pain; some GI Symptoms (nausea and diarrhea); ...
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headache; chills; muscle & joint pain; muscle & joint pain; some GI Symptoms (nausea and diarrhea); some GI Symptoms (nausea and diarrhea); injections site soreness; This is a spontaneous report from a contactable pharmacist reported for self. This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. She experienced injections site soreness on the day 07Jan2021 then resolved. The next day (08Jan2021) experienced headache, chills, muscle & joint pain, and some GI Symptoms (nausea and diarrhea). Outcome of the event injections site soreness was recovered. Outcome of other events was unknown. Information on batch/lot number was requested.
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| 46 | 2021-01-15 | diarrhea, abdominal pain |
Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swo...
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Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swollen, developed minor tightness in throat and feeling tongue swollen along with tremors and lightheadedness. BP 140/102, HR low 100s. Took Benadryl 50mg with bottle of water. Symptoms resolved over next 30 minutes. Developed numbness in left 4th and 5th digit which resolved at approximately 1 hour. About 1 1/2 hours after injection some abdominal cramping and 1 episode of diarrhea. BP and HR back to normal at about 1 hour after event.
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| 46 | 2021-01-17 | decreased appetite |
1. Runny nose/sore throat and extreme fatigue started about 4pm. 2. By 8pm I had extreme body chills...
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1. Runny nose/sore throat and extreme fatigue started about 4pm. 2. By 8pm I had extreme body chills/dizziness with a temperature of 101. That is when the muscle weakness went into overdrive. I was unable to sleep more than an hour overnight due to the chills and muscle pain. Early in the morning of 1/12 I messaged my supervisor and called the main pharmacy that I was unable to be there for my 9-5:30pm and would be out for the day. 3. Around noon on 1/12 the temperature went below 100 degrees and around 4pm on 1/12 I was finally able to eat something and start moving around. 4. On Saturday 1/16 I started having right arm weakness and my fingers tingling/numbness that hasn?t resolved. This is the arm that I received both injections in.
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| 46 | 2021-01-17 | vomiting |
12/23 vaccine' 12/27/2020 lower abdominal pain, woke up with symptoms, severe. vomited 1x. Sharp pa...
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12/23 vaccine' 12/27/2020 lower abdominal pain, woke up with symptoms, severe. vomited 1x. Sharp pain. Intermittent. 12/28/2020 pain got less 12/29/2020 referred to pcp. Thought possible ovarian cyst. 12/30 Pain continued, lower abdominal.
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| 46 | 2021-01-17 | nausea |
FEVER CHILLS, BODY ACHES (DEBILITATING), DIZZINESS, NAUSEA FOR 24 HRS. SWEATING AND CHILLS. UNABLE T...
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FEVER CHILLS, BODY ACHES (DEBILITATING), DIZZINESS, NAUSEA FOR 24 HRS. SWEATING AND CHILLS. UNABLE TO SLEEP BUT NO FEVER LAST NIGHT AND THIS AM. TOOK IBUPROFEN 600 EVERY 6 HRS.
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| 46 | 2021-01-17 | difficulty swallowing |
I noticed that my arm started itching, tingling and my whole arm and hand became weak. I started bur...
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I noticed that my arm started itching, tingling and my whole arm and hand became weak. I started burning under my armpits. Then, I started having issues swallowing. I felt a general feeling of weakness all over. I went to the ER because I was scared I was having a stroke.
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| 46 | 2021-01-17 | abdominal pain upper |
arm really hurt; stomach cramping; didn't feel well; This is a spontaneous report from a non-contact...
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arm really hurt; stomach cramping; didn't feel well; This is a spontaneous report from a non-contactable Nurse anesthetist reporting for herself via Pfizer employee (friend). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 08:00 at single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) received via an unspecified route of administration on 18Dec2020 at 08:00 at single dose. The patient was taking COVID-19 vaccine since is front line healthcare worker. The patient was vaccinated at hospital. Age at vaccination was 46 years. The patient's medical history and concomitant medications were not reported. The patient reported she had no problems with the first dose but after the second dose that night (08Jan2021) her arm really hurted and she had stomach cramping. She didn't feel well at all. The patient took two Advil and the next day (09Jan2021) she was fine and is still fine. The Pfizer employee stated her friend looked fine as she was exercising. Onset date of the events was also reported as 09Jan2021 with recovery date 10Jan2021. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
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| 46 | 2021-01-18 | nausea | Chills, Fever 100.5, Arm and Leg muscle pain, fatigue, Migraine, Nausea |
| 46 | 2021-01-18 | vomiting, nausea |
Day 1 sore arm at injection site Day 2 -4 am nauseous 6am vomiting every 30 min ... unable to ...
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Day 1 sore arm at injection site Day 2 -4 am nauseous 6am vomiting every 30 min ... unable to keep anything down. 1/2 phenergan suppository used. Still vomiting x 2. Additional 1/2 phenergan given. No more vomiting.
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| 46 | 2021-01-18 | nausea | Headache, Body aches, Nausea, Chills, Sweats, Took Tylenol |
| 46 | 2021-01-18 | difficulty swallowing |
I waited the 15 minutes. I walked to my car and drove to work. Got very busy with work, coughed here...
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I waited the 15 minutes. I walked to my car and drove to work. Got very busy with work, coughed here and there. Noticed my tongue felt swollen and tried to swallow some water and had difficulty, realized I was having a little anaphalxsis reaction. It started approximately it 12pm, maybe earlier, I was busy.
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| 46 | 2021-01-18 | abdominal pain upper, nausea |
On my second does the same night on 1/13/2021 I started feeling nauseas. The next morning on 1/14/20...
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On my second does the same night on 1/13/2021 I started feeling nauseas. The next morning on 1/14/2021 I felt horrible, my stomach was hurting, my left arm was swollen, felt really weak & tired, I had a lot of fatigue & I felt very nauseas. It last 24 hrs.
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| 46 | 2021-01-18 | nausea |
Strong headache, mild nausea, tired, arms were like Jell-O, those started 20 minutes after the vacc...
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Strong headache, mild nausea, tired, arms were like Jell-O, those started 20 minutes after the vaccine and lasted for 2 1/2 days. The next day was the soreness around the injection site.
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| 46 | 2021-01-19 | nausea |
About 10 minutes after injection - extreme sedation, flushing, hives and itching on right side of ch...
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About 10 minutes after injection - extreme sedation, flushing, hives and itching on right side of chest, and continuous cough. Was administered one dose of epi-pen injection, steroid injection, and oral benedryl by doctor on site. 20 minutes later flushing, headache, and extreme nausea. Was given second dose of epi-pen and sent to the hospital in an ambulance for monitoring.
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| 46 | 2021-01-19 | diarrhea |
I have had a headache since injection was given on the day of I did have. Diarrhea the day of. And a...
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I have had a headache since injection was given on the day of I did have. Diarrhea the day of. And also neck stiffness for three days after vaccine
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| 46 | 2021-01-20 | nausea |
Employee experienced shortness of breath, chest tightness, nausea and headache after vaccination and...
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Employee experienced shortness of breath, chest tightness, nausea and headache after vaccination and needed prolonged monitoring post vaccination. Improved with rest.
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| 46 | 2021-01-20 | nausea |
Itchy started within 3-5 minutes after injection. Started in scalp this time and then moved througho...
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Itchy started within 3-5 minutes after injection. Started in scalp this time and then moved throughout body down to feet. After 45 minutes of it not going away, received a shot of Benadryl in left hip. Itching started to subside within 30 minutes of getting the Benadryl shot. Nauseous feelings and joint pain started about 3.5 hours after vaccine was administered.
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| 46 | 2021-01-20 | nausea | Nausea, headache, armpit pain, muscle pain, injection site pain, tiredness |
| 46 | 2021-01-20 | nausea |
Nauseous; Fever; Chills; Headache; This is a spontaneous report from a contactable consumer (patient...
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Nauseous; Fever; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient supposed to be calling after she get vaccine to report any side effects. The patient just nauseous, fever, chills, headache. The patient had started symptoms on 09Jan2021 and still had her symptoms today (10Jan2021). The outcome of the events was not recovered.
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| 46 | 2021-01-21 | diarrhea, nausea |
Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fe...
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Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fever starting around 24 hours after vaccine dose, subsiding with medication after about 8 hours. Diarrhea and blanching red rash at chest, shoulders and back starting 48 hours after vaccine dose.
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| 46 | 2021-01-21 | nausea |
Feeling dizzy like I just got off a cruise ship with nausea and hot flashes on and off no fever but ...
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Feeling dizzy like I just got off a cruise ship with nausea and hot flashes on and off no fever but felt intermittently clammy/sweaty started on the 20th and resolved midday on the 21st until the morning of the 22nd, the dizzy/nausea returned and occasional sweaty/clammy feeling. Called OHS and they recommended calling pcp. PCP called in script for zofran and instructed me to take that and dramamine and call if not improved by Monday the 25th
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| 46 | 2021-01-21 | nausea, vomiting |
Nausea and vomiting within 45 minutes of vaccine. Left side facial numbness, allergic swelling of f...
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Nausea and vomiting within 45 minutes of vaccine. Left side facial numbness, allergic swelling of face within 1 hour of vaccine, lasting 24 hours with Benadryl & Pepcid given as treatment. Numbness of face occurring 1 week post vaccine. Benadryl given as treatment.
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| 46 | 2021-01-21 | diarrhea |
Shortly after the vaccination I got a burning warming sensation up and down my left leg which still ...
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Shortly after the vaccination I got a burning warming sensation up and down my left leg which still presist today. I had a fever for one day but had diarrhea for about a week.
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| 46 | 2021-01-21 | difficulty swallowing |
allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well ...
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allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well a few minutes after receiving it; her throat felt thick; had trouble swallowing; This is a spontaneous report from a contactable other HCP and pharmacist. A 46-year-old female patient received the first dose of BNT162b2 (lot: EL3247, Expiry Date: May2021), via an unspecified route of administration in left arm on 15Jan2021 at 0.3 mL, single for covid-19 immunization. Medical history included food allergic. The patient's concomitant medications were not reported. The patient experienced allergic reaction on 15Jan2021. The patient alerted she wasn't feeling well a few minutes after receiving vaccine. The patient was experiencing being flushed, had a fast heart rate, and her heart rate kept increasing over time, despite two benadryl, the patient had allergic reactions in the past due to food, so the patient knew what it felt like, so could expect it, so the patient spoke up soon, and the Epipen was given 28-30 minutes later, and after that, the patient said her throat felt thick and she had trouble swallowing, so was taken to the hospital. The patient seemed to be getting worse, after time, after the Epipen. The patient was most likely admitted to the hospital. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-01-22 | abdominal pain |
patient went back to the procedure center after receiving vaccine after 15 min observation and compl...
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patient went back to the procedure center after receiving vaccine after 15 min observation and complained of N, abdominal pain and out of body experience with inability to talk or describe what happened. Palpitations. No CP, SOB, wheezing or visual changes. HR 140's w occ PVCs, SBP 160-170's SpO2 100% with pt appearing flushed and drowsy. O2 NC, NS 1 liter IV, zofran 4mg IVP x1 given. Admitted to procedure center at 1500 and discharged at 2359.
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| 46 | 2021-01-23 | nausea | Hives itching headache fatigue nausea joint and muscle pain concentration problems |
| 46 | 2021-01-23 | nausea |
Metal taste (immediate - within 5mins post injection and lasted approx 5days) Fever of 101; myalgia;...
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Metal taste (immediate - within 5mins post injection and lasted approx 5days) Fever of 101; myalgia; chills; nausea; loss of taste; malaise (almost exactly 12-hrs post injection and stopped 24-hrs post injection (almost to the exact timing from inj)). Please note: Lot number could be: ER4176 or EU4176 (unable to clearly ready handwriting on the card)
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| 46 | 2021-01-24 | difficulty swallowing, nausea |
Approximately 5-10 minutes after 1st dose of vaccine, patient complained of feeling sweaty, nauseous...
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Approximately 5-10 minutes after 1st dose of vaccine, patient complained of feeling sweaty, nauseous, and not feeling right. She was tachycardic and bradycardic soon after. She was transported to the ED for evaluation. She endorsed lightheadedness, chest pain, and trouble swallowing upon ED triage. She was given diphenydramine 25mg PO x 1 dose and observed for ~2.5 hours prior to discharge.
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| 46 | 2021-01-24 | diarrhea | Headache, Sore arm at injection site, diarrhea |
| 46 | 2021-01-24 | nausea |
I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes we...
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I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes were hurting and burning really bad.
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| 46 | 2021-01-24 | nausea | Shortly after the vaccination the patient complained of nausea and jitters. |
| 46 | 2021-01-25 | nausea, diarrhea |
On 1/22, two days after injection of 2nd dose, recipient developed diarrhea, nausea, aches which per...
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On 1/22, two days after injection of 2nd dose, recipient developed diarrhea, nausea, aches which persisted for 48 hours.
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| 46 | 2021-01-25 | nausea |
Received 2nd vaccine 1/22/21. The next day I had fatigue, chills, low-grade temp, mild nausea, body ...
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Received 2nd vaccine 1/22/21. The next day I had fatigue, chills, low-grade temp, mild nausea, body aches, and arm was more sore than 1st vaccine. Symptoms were pretty much resolved by Sunday afternoon.
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| 46 | 2021-01-25 | nausea |
Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at i...
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Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at injection site, radiated: up and across L shoulder blade area, up neck and into head, down to L fingertips 0600 -all above continued, R knee joint pain (sharp/stabbing) 1400 -all above continued except R knee joint pain; spinal pain and intercostal pain began 1900 -all above continued; TMJ, jaw, and 'tooth' pain began Monday, 1/11/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Tuesday, 1/12/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Went to dentist (scheduled appointment on Monday) for cleaning and thorough exam...exam was normal Wednesday, 1/13/21 continuation of symptoms from 1/12/21, but pain worse, ear pain Thursday, 1/14/21 0630 had eaten a full can of chicken noodle soup. Was sitting and working on CEs for work, had taken medications for the day, but added in hydrocodone, half of a 7.5/325mg tablet and ibuprofen 200mg. Felt a severe wave of nausea. Laid my head down on my arms on the table. Do not remember getting up, but remember walking through the kitchen in front of the refrigerator, reaching up to feel my pulse, felt two beats which were too far apart and thought to myself, "I'm going to faint". Apparently I was able to walk about 6 feet further, but I don't remember it. I don't know what time I fainted, but I think I must have fallen. I woke up sometime after 7, disoriented and my head hurt, lying on the kitchen floor. My husband came to my side after I called out to him about 5 times. I was drenched in sweat and very weak. When firefighters arrived they said my heart rate was 'all over the place', from 46 to I don't know what (did not hear). Ambulance arrived around 0730. Glucose was normal. Was taken for evaluation. Was given IV NS (I think 1000mls). Labwork was drawn. CXR, CT, and EKG. ER Dr recommended I follow up with my cardiologist, as she noted mitral valve regurgitation and thought a Holter monitor would be advisable. CXR and CT normal. EKG normal sinus rhythm, but showed anteroseptal infarct of unknown age, confirmed by cardiologist who read the EKG. Also seen by my PCP at 1430, he checked my ears, as they had been hurting as well, said they were clear. Advised alternating tylenol and ibuprofen Q4-6H. Friday and Sunday 1/15 and 1/16 night sweat, TMJ pain, nauseated, headache, neckache, fatigue, shoulders sore, eyes sore, inner ear pain Sunday, 1/17 0500 woke up, lying in bed, dizzy, clammy palms, chest pain (mid-clavicular, just below left breast, stabbing), night sweat, TMJ pain, nauseated, headache, neckache, fatigue, L & R flank pain, BP 115/70, HR 54 Monday 1/18, Tuesday, 1/19, Wednesday 1/20, Thursday 1/21, Friday 1/22, and Saturday 1/23 varying degrees of: fatigue, nausea, dizziness, TMJ, jaw, and 'tooth' pain, palpitations, and ear pain. TMJ and jaw pain worsens with activity.
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| 46 | 2021-01-25 | nausea, diarrhea, vomiting |
cramping; Diarrhea; body aches; Headache; Nausea; Vomiting; This is a spontaneous report from a cont...
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cramping; Diarrhea; body aches; Headache; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient) and another consumer. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: 30Apr2021), intramuscular (right arm) on 11Jan2021 (around 1:10-1:30pm) at single dose for Covid-19 immunization. The patient received the first dose of COVID Vaccine (BNT162B2, lot number: EK5730, expiration date: 31Mar2021) on 21Dec2020, intramuscular (right arm) for Covid-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021, the patient experienced nausea, some vomiting which has subsided, diarrhea, headache and body aches. The patient also stated that she woke up at 3 a.m. this morning (12Jan2021) vomiting. She vomited for about an hour and half. The vomiting has subsided and now she is just nauseated. The diarrhea initially began about 7:30 a.m. She had 3 bowel movements and she hasn't had a movement since about 8:30. She still has cramping but nothing else. The body aches started within last half hour or so. The headache has been the entire time since 3 a.m., starting when the vomiting occurred. The vomiting was more important at that moment, but she knows her head hurting at the time. The patient verified it was her second COVID vaccine. She received the vaccine yesterday (11Jan2021), between 1:10-1:30p.m. The patient reported that she did have bloodwork, but not in regard to the COVID vaccine. She had bloodwork done Monday, 04Jan2021. The outcome of vomiting was recovering; outcome of event cramping was unknown; while the outcome of other events was not recovered.
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| 46 | 2021-01-25 | nausea |
day of felt "fuzzy" tired chills/rigors and fever 103, body/aches. 1/7 temp 99 still taking APAP q 3...
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day of felt "fuzzy" tired chills/rigors and fever 103, body/aches. 1/7 temp 99 still taking APAP q 3 hrs. nausea. rt axilla swollen and severe pain. 18/ bilateral hand numbness and tingling up to elbow. temp normal, nausea better. no axilla or neck swelling. reports tremors (that aren't visible) when tries to write "feels not right". 1/11 all sxs resolved. ok to work.
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| 46 | 2021-01-26 | nausea |
Chest tightness/ heaviness ( like an elephant sitting on my chest ), severe headache , and ringing i...
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Chest tightness/ heaviness ( like an elephant sitting on my chest ), severe headache , and ringing in ears began about 1 hour after vaccine given. Fever greater than 102 / chills began about 2 hours after vaccine given. Severe body aches, nausea, and extreme fatigue, extreme weakness, dizziness, and chest pain when taking a deep breath began within 4 hours after vaccine.
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| 46 | 2021-01-26 | nausea |
Cold chills; Body aches; Nausea; Right arm sore/site of injection started to get sore; Headache; bac...
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Cold chills; Body aches; Nausea; Right arm sore/site of injection started to get sore; Headache; back is hurting a little more, and she is more achy; joints are starting to get tight; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration into right arm on 12Jan2021 12:15 at a single dose for covid-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity; Hashimotos Disease diagnosed 10 years ago; pre-diabetic diagnosed 5 years ago (she does not have to take insulin or take blood sugars daily). Concomitant medication included metformin for Pre-diabetic. The patient had no previous history of immunization. No additional vaccines administered on same date of the Pfizer covid vaccine. The patient experienced headache on 12Jan2021 13:30 with outcome of not recovered; right arm sore further described as site of injection started to get sore on 12Jan2021 19:00 with outcome of not recovered; cold chills on 13Jan2021 02:00 with outcome of not recovered; body aches on 13Jan2021 02:00 with outcome of not recovered; nausea on 13Jan2021 02:00 with outcome of recovering. The patient also reported on unspecified date in Jan2021, her back is hurting a little more, and she is more achy, joints are starting to get tight. No ER or physician's office required yet. No prior vaccinations within 4 weeks. Therapeutic measures were taken as a result of headache and cold chills as TYLENOL extra strength. Outcome of events back pain and tight stiffness was unknown.
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| 46 | 2021-01-27 | nausea, vomiting |
25th Jan-body aches, fatigue, HA, nausea 26th Jan 2021-Body aches, fatigue, HA, N/V, Chills, severe ...
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25th Jan-body aches, fatigue, HA, nausea 26th Jan 2021-Body aches, fatigue, HA, N/V, Chills, severe low back pain, bilateral arm tingling 27th Jan 2021-Body aches, HA, fatigue 28th Jan 2021-Fatigue
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| 46 | 2021-01-27 | nausea |
I developed a left kidney stone unexpectedly on the morning of December 31st. I did not have a his...
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I developed a left kidney stone unexpectedly on the morning of December 31st. I did not have a history of kidney stones prior to this. I was seen in the emergency room. I had a CT scan that showed I passed a stone during my time in the ER. I was treated with pain and anti-nausea medications. I was in the ER for 4 hours.
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| 46 | 2021-01-27 | nausea, vomiting |
Nausea; Vomiting; Muscle pain; Fatigue; Chills; This is a spontaneous report from a contactable heal...
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Nausea; Vomiting; Muscle pain; Fatigue; Chills; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1686), intramuscular in left arm, on 11Jan2021 at 14:15, at a single dose, for COVID-19 immunization. The patient's medical history included hypertension, Hashimoto's, and allergies to sulfa. The patient had unspecified concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: EK5730) on 19Dec2020 at 08:00 AM (intramuscular in left arm) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 12Jan2021 at 10:30 PM, the patient experienced nausea, vomiting, muscle pain, fatigue, and chills. No treatment was administered for the events. The patient had not been tested for COVID-19 post-vaccination. The patient was recovering from the events.
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| 46 | 2021-01-27 | nausea, abdominal pain upper, decreased appetite | chills, body aches, headache, nausea, loss of appetite, stomach cramps, fatigue lasting 24 hours |
| 46 | 2021-01-28 | nausea |
I only experienced mild arm pain after the injection. Five days later, I was walking down a hallway ...
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I only experienced mild arm pain after the injection. Five days later, I was walking down a hallway at the hospital (I am a physician) when all of a sudden I experienced vertigo (I was not dizzy, but I felt my vision shift to the left). I fell down, landing against 2 crash carts that were in the hallway. I did not lose consciousness. I had persistent dizziness and nausea for at least 10 days afterwards.
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| 46 | 2021-01-31 | diarrhea | Diarrhea |
| 46 | 2021-01-31 | nausea |
beginning on 1/31/2021 at approximately 5:00pm I noticed joint pain in the elbow and hand/wrist of t...
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beginning on 1/31/2021 at approximately 5:00pm I noticed joint pain in the elbow and hand/wrist of the arm the injection was given in. This joint pain progressed to then include muscle pain and by the morning of 2/1/2021 joint/muscle pain was not localized to one specific area of the body and I was experiencing nausea
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| 46 | 2021-01-31 | nausea |
malaise; weakness; nausea; This is a spontaneous report from a contactable healthcare professional (...
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malaise; weakness; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Dec2020 08:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant at time of vaccination. Concomitant medication included linaclotide (LINZESS), omeprazole, ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient previously took erythromycin and DEMEROL and experienced allergy. The day after first injection, patient had extreme malaise, weekness and nausea on 20Dec2020 06:00. Outcome of the event was recovered. No treatment was received for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 46 | 2021-01-31 | diarrhea |
severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; blee...
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severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; bleeding gums; small hematomas on legs; extremely hot diarrheas; horrible burning sensation; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EJ1686, expiration date was unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 14:15 at a single dose for COVID-19 immunization administered at the hospital. She received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EK5730, expiration date was unknown) via an unspecified route of administration on the left arm on 18Dec2020. Relevant medical history included known allergies to shellfish. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. On 09Jan2021 at 12:00 AM, the patient experienced severe headache, severe neck pain, severe arm pain, fever at 103 degrees Fahrenheit (F), swollen lymph node, bleeding gums, small hematomas on legs, and extremely hot diarrheas that she had this horrible burning sensation. The patient did not receive any treatment for the adverse events (AE). The patient underwent further lab tests and procedures, which included COVID test via nasal swab post vaccination on 13Jan2021, which resulted negative. The patient was recovering from all the events.
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| 46 | 2021-02-03 | nausea |
On day 1 post immunization @ 14 hours, I started to feel nauseated then developed chills, flushing ...
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On day 1 post immunization @ 14 hours, I started to feel nauseated then developed chills, flushing of face, body aches. On about 24 hours post immunization, I developed temp. 100.9 , chills and with wet cough , headache. Post 24 hours, fevers, sweats, wet cough and continued headache. On day 3 post immunization, no more fevers, wet cough, and chills with sweats, head ache , body ache and pain at sight subsided. As of date of reporting experiencing, sweats, chills and wet cough. Starting taking Tylenol and Ibuprofen for symptom management.
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| 46 | 2021-02-03 | nausea, retching |
Pfizer-BioNTech COVID-19 Vaccine EUA Nausea, chills, HA, muscle aches, weakness and some dizziness. ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Nausea, chills, HA, muscle aches, weakness and some dizziness. The Nausea started around 05:00 Am on 2/3/21 some dry heaving. Other symptoms have been progressively worsening throughout the morning. No Temp.
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| 46 | 2021-02-03 | nausea |
WOKE UP WITH TERRIBLE MIGRAINE THAT MADE ME NAUSEOUS AND BODY ACHES WITH EXTREME FATIGUE. MIGRAINE ...
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WOKE UP WITH TERRIBLE MIGRAINE THAT MADE ME NAUSEOUS AND BODY ACHES WITH EXTREME FATIGUE. MIGRAINE LASTED CLOSE TO 10 HOURS. BODY ACHES AND FATIGUE LASTED 2 DAYS.
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| 46 | 2021-02-04 | nausea |
Chills began about 1/2 hour later. The chills got continuously worst as the day went on.; Immediatel...
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Chills began about 1/2 hour later. The chills got continuously worst as the day went on.; Immediately after the shot I felt nauseated; lethargic; ache and pain in my arm is tremendous; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 vaccine; unknown lot number and expiration date), intramuscular left arm on 21Jan2021 11:30 at a single dose for covid-19 immunization. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. The patient received the most recent COVID-19 vaccine in nursing home/senior living facility. The patient reported that she has never had an adverse effect to this degree from any injections or vaccinations. She mentioned that immediately after the shot (21Jan2021 11:30 AM), she felt nauseated then chills began about 1/2 hour later. The chills got continuously worst as the day went on. It has only been about 4 hours since the shot and she was very lethargic and the ache and pain in her arm was tremendous. She was an extremely active athlete and she has not been sick in over 2 years. The patient did not receive treatment for the adverse events. The events were considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event chill was not recovered while the outcome of the other events was unknown. The following information on the batch/lot number has been requested.
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| 46 | 2021-02-04 | nausea, vomiting |
Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we att...
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Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we attributed to nerves and I went to go home without reporting. During the drive the headache and nausea got worse and my extremities and face began to tingle. My chest felt tight. My body was shaking. My colleague noted weak pulses and pale complexion. I am a doctor and gave myself epinephrine 0.3 mg IM and within 60 to 90 seconds the symptoms improved dramatically. I had my husband pick me up at the office and went home. The headache and nausea worsened on the drive but then settled down significantly. I rested for a few hours, then took oral pred 20 mg at about 2:45. I noticed that my headache was back and very intense at about 3:15 pm. No nausea this time, but my left eye began itching and it was very tight / hard to breathe. My extremities began tingling and I had spasms / tremors of my muscles. I injected another 0.3 mg epi into my thigh and followed with dex sodium phosphate 4 mg IM. Symptoms resolved within about 2 to 3 minutes. I took 40mg more of oral pred. I also took 10 mg of pepcid PO. I am still feeling well now with no headaches or other symptoms at this writing (7:30 pm), but I have another doctor with me and we are 2 minutes from the ER if needed. I am marking unknown below since it has only been a few hours without symptoms.
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| 46 | 2021-02-04 | nausea |
symptoms began 02/02/21 that night and lasted about 24 hours. headache, muscle aches, nausea, fever...
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symptoms began 02/02/21 that night and lasted about 24 hours. headache, muscle aches, nausea, fever, chills, right arm soreness
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| 46 | 2021-02-05 | nausea | 102° F temperature, severe headache, severe back ache, nausea |
| 46 | 2021-02-07 | abdominal pain |
Abdominal pain at the end of her 15 min monitoring. BP 168/92, HR 83, Pt denies any other symptoms....
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Abdominal pain at the end of her 15 min monitoring. BP 168/92, HR 83, Pt denies any other symptoms. RN had medic assit. Pt states she recently had a colonoscopy and stated she felt fine to go after being checked at by RN and medic.
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| 46 | 2021-02-09 | decreased appetite, nausea |
Chills and night sweats started 2 days later; Chills and night sweats started 2 days later; Pain ove...
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Chills and night sweats started 2 days later; Chills and night sweats started 2 days later; Pain over left eye; Nausea; No appetite; This is a spontaneous report from a contactable consumer reported for herself. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, brand=Pfizer, lot number=EL3247) via unspecified route of administration at age of 46 years old on 21Jan2021 05:00 PM at single dose at left arm, for COVID-19 immunization. The patient medical history included patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Other concomitant medications the patient received within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT 25mg), atorvastatin statin. It was reported patient experienced chills and night sweats started 2 days later. Pain over left eye, nausea, no appetite, can sleep at night. All the adverse events started on 23Jan2021 04:00 PM. It was reported case type non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Since the vaccination, the patient had been tested for COVID-19 on 27Jan2021: Nasal Swab (PCR): Negative. There was no treatment received for the adverse event. Outcome of events at the time of last observation was recovering.
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| 46 | 2021-02-09 | nausea |
I experienced headaches, chills, muscle aches, felt feverish, felt hot and cold but mainly severe he...
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I experienced headaches, chills, muscle aches, felt feverish, felt hot and cold but mainly severe headache. I was also having nausea. I saw PCP on 01-06-2021 and he gave me Phenergan 6.25-10mL, 5mL syrup with codeine to help with my headache. I only took the Phenergan one time in the evening before I went to bed. I also got tested for a rapid Covid-19 test which was negative.
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| 46 | 2021-02-09 | diarrhea |
Severe diarrhea; This is a spontaneous report from a non-contactable consumer (patient herself). A 4...
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Severe diarrhea; This is a spontaneous report from a non-contactable consumer (patient herself). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on unspecified date at SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not have COVID-19 prior vaccination. The patient did not test for COVID-19 post vaccination. It was reported that the patient did not receive other vaccines in four weeks, "other vaccine same date details" were also provided as 24Jan2021 (as reported). The patient experienced severe diarrhea on 24Jan2021 12:30 which resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of severe diarrhea. Outcome of the event was not recovered. No follow-up attempts are possible; Information on the lot/batch number cannot be obtained.
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| 46 | 2021-02-14 | nausea |
Nausea; Severe headache; Body/joint aches; Body/joint aches; This is a spontaneous report from a con...
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Nausea; Severe headache; Body/joint aches; Body/joint aches; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL4238; Expiration date was not reported) on 25Jan2021 (14:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included hypertension (HTN), asthma and allergies. The patient had unspecified concomitant medications. The patient was not pregnant at the time of vaccination. On 26Jan2021 (09:00), the patient had nausea; severe headache; and body/joint aches. The patient did not receive any treatment for the reported events. The outcome of the events, nausea, severe headache and body/joint aches, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
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| 46 | 2021-02-16 | difficulty swallowing |
Fever, chills, muscle pain, unable to swallow solid food and headache for 48 hours. Large rectangle ...
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Fever, chills, muscle pain, unable to swallow solid food and headache for 48 hours. Large rectangle red rash that is warm to touch surrounding injection site appearing at 48 hours and is still present 5 days after injection.
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| 46 | 2021-02-17 | difficulty swallowing |
tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingl...
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tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; raised blood pressure; metallic taste; This is a spontaneous report from a contactable healthcare professional. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number 0041297301), via an unspecified route of administration in left arm on 15Jan2021, at 17:00 as first single dose for covid-19 immunisation. Medical history included obesity, opiate allergy and artichokes allergy from an unknown date. Concomitant medication included unspecified probiotic, levothyroxine (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), ergocalciferol (VIT D), linum usitatissimum seed oil (FLAXSEED OIL NATURE MADE). The patient experienced the following non-serious events: metallic taste on 15Jan2021, at 17:30 with outcome of recovered in Jan2021; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing on 15Jan2021, at 17:30 with outcome of recovered in Jan2021; raised blood pressure on 15Jan2021, at 17:30 with outcome of recovered in Jan2021. Details were as follows: following vaccination the patient reported a metallic taste in her mouth, then a tingling sensation in her jaw which extended to her nose and it felt numb with difficulty swallowing, and she also had raised blood pressure. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19.
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| 46 | 2021-02-18 | difficulty swallowing |
Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spo...
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Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: not available), via an unspecified route of administration on left arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Age at vaccination was 46 years. The patient was not pregnant at the time of vaccination. Medical history included food irritations. Concomitant medications included unspecified vitamins (received within 2 weeks of vaccination). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced tongue swelling, difficulty swallowing, raised blood pressure, redness, body weakness on 01Feb2021 at 16:30. The events resulted in emergency room visit/ department or urgent care visit. The patient received breathing treatments and unspecified IV medication for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.
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| 46 | 2021-02-19 | nausea |
24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 ...
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24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 days after vaccine), woke up with vertigo, visual changes, severe nausea, diagnosed with cerebrovascular accident
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| 46 | 2021-02-21 | nausea |
Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) ...
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Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) issue is my throat, I feel like I have something (stuck) in my throat; I feel like I can't breathe normally; I can't speak; I do not feel well/I feel terrible/I feel isolated; I have pain in my body; I could hardly stand up/I did not got to work; Feel an itch, like an allergy, it was not a rash, just an urge to scratch me; Feeling dizzy; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she received the COVID-19 vaccine at a hospital, patients were allowed to stay for 30 minutes, then they were released. After she left the hospital she started to feel an itch, like an allergy, it was not a rash, just an urge to scratch herself. She started feeling dizzy, nauseous, and a headache. Yesterday (02Feb2021), she could hardly stand up. Today (03Feb2021) she did not got to work, she do not feel well, she have pain in her body, fever and chills. The (most serious) issue was her throat, she feel like she have something (stuck) in her throat, she can't speak, she feel like she can't breathe normally. She haven't felt well at all, today is the 3rd day after receiving the vaccine and she couldn't go to work, she was nervous because she was fine (before receiving the vaccine). She does not want to go out because she feel very tired and dizzy, she was afraid of falling down in the street and getting hurt, she can hardly walk and she feel tired, experienced fatigue and sore throat. She have a cold, she feel terrible. she feel isolated and afraid. She will have to go to the hospital, if she cannot breathe well. Outcome of the events was unknown. Information about Lot/batch no has been requested.
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| 46 | 2021-02-22 | nausea, vomiting |
Day 2-3: fever, chills, body aches, joint and muscle pain, headache, nausea, fatigue and vomiting Da...
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Day 2-3: fever, chills, body aches, joint and muscle pain, headache, nausea, fatigue and vomiting Day 4-5: felt completely fine Day 5-6: that evening, all of the same symptoms returned, including fever of 102 Day 7-9: felt completely fine Day 10-11: all symptoms returned, including fever of 101 Day 12: today, feel completely fine
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| 46 | 2021-02-28 | abdominal pain upper, diarrhea |
About 5 minutes after the shot, I developed a sudden sharp pounding headache at the top of the head ...
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About 5 minutes after the shot, I developed a sudden sharp pounding headache at the top of the head & near the temple. I also got clammy/sweaty in my neck & the back of head. My hair got damp at the scalp. At nurse took my BP & it was 142/88 which is very high for me. I usually average a low BP. This reaction slowly subsided within 30 minutes. I was able to drive home. I felt nothing more on this day other than soreness in the injection site. On 2/23/21 I woke up with stomach cramping & had looser stools than usual. I also had fatigue & lethargy all day, which got stronger towards the evening. This lasted until 2/25/2021.
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| 46 | 2021-02-28 | decreased appetite |
injection site is painful; chills; fever with temperature of 99.7 F; headache; tiredness; loss of ap...
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injection site is painful; chills; fever with temperature of 99.7 F; headache; tiredness; loss of appetite; joint pain; feeling unwell; received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the left arm on 22Jan2021 13:15 (lot number: EL3302; expiration date: unknown) at a single dose for covid-19 immunization. Medical history included mental disease, seasonal allergy in spring and allergies to sulfa antibiotics. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included aripiprazole (ABILIFY). The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the right arm on 05Jan2021 13: 45 (lot number: EJ1685) at a single dose for covid-19 immunization. The patient received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021. On 23Jan2021 02:00 AM, she had chills, fever with temperature of 99.7 F, headache, tiredness, loss of appetite, joint pain and feeling unwell for 2 days post vaccination. She also mentioned that the injection site was painful on 25Jan2021 for 4 days post vaccination. The patient did not received treatment for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was unknown.
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| 46 | 2021-03-01 | nausea |
sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints h...
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sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints hurt; very large lymph node swelling on left (neck/collarbone/under arm).; cough; Spoke to MD regarding feet as it was difficult to walk; vaginal bleeding; headache; fever 101.9; felt like I was in shock; uncontrollable shaking; fast breathing; freezing; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 10Feb2021 at 11:00 AM (at the age of 46-year-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to sulfa drugs. The patient has pins in both feet from prior surgery. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ) on 19Jan2021 at 11:30 AM (at the age of 46-year-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient stated that it was unknown if prior to the vaccination, she had COVID-19. The vaccine was administered in a Nursing Home facility. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccination. On 11Feb2021 the patient awoke at 1:30 AM with uncontrollable shaking, fast breathing, and she was freezing. She had no temperature at that time, almost felt like she was in shock. She took a shower and got calmed down. She was very nauseous but able to go back to sleep. At 04:30 AM she awoke again, this time with headache and a fever of 101.9. She continued with a fever in the 101.1 to 101.9 range for remainder of the day. The next day, 12Feb2021, she awoke feeling better and no fever but she had welts on her toes and her feet were swollen. Both feet and hand joints hurt and she had very large lymph node swelling on left (neck/collarbone/under arm). She also had developed a cough. She spoke to her MD regarding her feet as it was difficult to walk. They directed her to the Emergency Room (ER). The ER staff said to watch for two days. Later that evening (12Feb2021) she started having some shortness of breath and vaginal bleeding. She has an IUD and has not had a period for four years. She called the ER and they gave same advice. She had no fever that day (13Feb2021) but she woke around 3:30 AM soaked. As of 14Feb2021 she was still short of breath on/off and still has sore feet. The patient did not receive treatment for the events. Lab data included Fever of 101.9 on 11Feb2021 and fever in the 101.1 to 101.9 range also on 11Feb2021. The clinical outcome of shortness of breath was reported as not recovered. The clinical outcome of shock-like symptom, shaking, fast breathing, feeling cold, nauseous, headache, fever, welts, swelling of feet, arthralgia, lymphadenopathy, cough, gait disturbance, vaginal bleeding, hyperhidrosis was reported as recovering. The patient has not been tested for COIVD-19 after the vaccination. Information about lot/batch number has been requested.
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| 46 | 2021-03-02 | nausea, vomiting, diarrhea, abdominal discomfort |
migraine; face numb and tingling sensation; face numb and tingling sensation; vomiting; diarrhea; fe...
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migraine; face numb and tingling sensation; face numb and tingling sensation; vomiting; diarrhea; fever; body aches and muscle aches; body aches and muscle aches; really sick; She had the horrible headaches; Nausea; Upset stomach; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), intramuscular in the left arm on 25Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included migraine. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 for COVID-19 immunization and experienced flu like symptoms, body aches, headache, muscle aches and light fever. No additional vaccines administered on the same date of the Pfizer suspect. The patient had questions about the side effects of COVID vaccine. The patient experienced migraine, face numb and tingling sensation, vomiting, diarrhea, fever, body aches and muscle aches, and has been really sick the night after that second vaccine on an unspecified date in Jan2021. It is slowly getting better and now it had been a Monday a week later from the second dose and she still has the body aches, fever that comes and goes, and headaches that have just been ongoing. She wanted to know if anyone reported any of this or prolonged symptoms. She also mentioned horrible headaches, nausea, vomiting, numbness and tingling in face on an unspecified date in Jan2021. She mentioned again the nausea and upset stomach, body and muscle aches and fever she still has a little of on an unspecified date in Jan2021. The biggest thing was the headaches. The body and muscle aches and fever comes and goes. Thought she was over the fever and it started back again yesterday. She was unable to provide seriousness criteria when queried, only stated that it was very frustrating, it's not life threatening, but she is at home versus being at work. The events migraines, fever off and on, body and muscle aches, diarrhea, vomiting, numbness and tingling in face, really sick required a visit to the Physician office. The outcome of the events migraine, Tingling, Numbness in face, Vomiting, Diarrhea, Fever, Generalized aching, Muscle ache and sickness was not recovered while the outcome of the events headache, nausea and upset stomach was unknown.
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| 46 | 2021-03-07 | nausea |
Nausea, something in throat, involuntary finger movement, especially in left hand. Benadryl 50 mg IM...
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Nausea, something in throat, involuntary finger movement, especially in left hand. Benadryl 50 mg IM given.
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| 46 | 2021-03-14 | nausea |
Throat swelling; severe allergic reaction to the Pfizer vaccine; chills; sweats; nausea; This is a s...
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Throat swelling; severe allergic reaction to the Pfizer vaccine; chills; sweats; nausea; This is a spontaneous report from two contactable physicians. A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267), via an unspecified route of administration on 13Feb2021 at a single dose in left arm for COVID-19 immunization. Medical history included herpes Simplex I, back pain, SI joint dysfunction, difficulty sleeping and allergy to raw tomatoes. The patient's concomitant medications were not reported. On 13Feb2021, the patient experienced throat swelling, severe allergic reaction to the Pfizer vaccine, chills, sweats, nausea, the seriousness of throat swelling, severe allergic reaction was reported as hospitalization, seriousness of the other events was reported as medically significant. Under anaphylaxis that the patient has EpiPen at home for raw tomatoes Clinical course: she had a severe reaction to the first shot presenting the following side effects: chills, sweats and nausea within 5 minutes and then developed throat swelling within 10 minutes, the patient was administered with an EpiPen, Benadryl and was sent to the ER where she received Benadryl IV monitored, eventually her symptoms diminished from 10 of 10 to a 6 in a scale of 10, the patient also received Prednisone 40 mg everyday for 4 days. She did have nausea and sweats. It was six out of ten in the ER. Then it went to four or five out of ten. It took four to five days to get back to normal. By five days after the vaccination she was back to normal. She had a virtual visit with a patient who apparently had a severe reaction after the first vaccine. It was set up in physical therapy office. HCP wants to know if it is safe for the patient to receive the second dose of the vaccine. HCP mentioned that this is her first patient who has a severe allergic reaction to the Pfizer vaccine. She was feeling better. She was told to call her doctor about getting the second shot. The bottom line is if they acted as severely as they did she would think the answer would be not to get the second. She was better. She felt fine. She has an allergy to raw tomatoes. She knows she is not supposed to have raw tomatoes. A couple of days ago she had a dressing that must have had raw tomatoes in it because she had throat swelling. The patient said what happened with Pfizer was more. She knew it when it was happening because it has happened before. She had no hypoxia. The patient reported that her pulse ox was checked and was in the high 90's. The patient was able to swallow. No drooling. She did have nausea and sweats. It was six out of ten in the ER. Then it went to four or five out of ten. It took four to five days to get back to normal. By five days after the vaccination she was back to normal. On 23Nov2020, the patient weighed 150 pounds and her height was 66 inches. The outcome of events was recovering. There is a causality, because it happened with 5 to 10 minutes after receiving the vaccination. She had to wait for 15 minutes. The patient had chills, sweats, and nausea within 5 minutes. She felt fine upon immediately receiving and then within 5 minutes she had chills, sweat, nausea, headache. Then within 5 to 10 minutes throat swelling. There is a causality, because it happened with 5 to 10 minutes after receiving the vaccination. She had to wait for 15 minutes. The patient had chills, sweats, and nausea within 5 minutes. She felt fine upon immediately receiving and then within 5 minutes she had chills, sweat, nausea, headache. Then within 5 to 10 minutes throat swelling.; Sender's Comments: Based on known safety profile and temporal association, the contribution of the suspect drug to the onset of events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-03-15 | nausea |
First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat cl...
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First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat closing; throat closing; This is a spontaneous report from a contactable consumer (Patient herself). A 46-Year-Old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration at Left arm on 16Feb2021 17:45 (at age of 46 years old) at single dose for COVID-19 immunisation. Relevant medical history included: Athsma-lasting trouble breathing after allergic reaction, Ehlers-Danlos Syndrome, PCOS (Polycystic ovarian syndrome), Hypothyroid. Known allergies was Cashews, pistachios, cat dander. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination. The patient experienced first dizziness and nausea Then itching Then tongue swelling/throat closing, all Adverse events started on 16Feb2021 17:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included COVID test type post vaccination was Nasal Swab, COVID test name post vaccination=PCR on 21Feb2021 with result Negative. Treatment (Epipen, IV Benadryl, Pepcid, Prednisone) received for all AE. The outcome of the events was recovered in 2021.
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| 46 | 2021-03-18 | vomiting |
Vomiting fainting took a nop as the day went on the pain on my R leg got worse; Vomiting fainting to...
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Vomiting fainting took a nop as the day went on the pain on my R leg got worse; Vomiting fainting took a nop as the day went on the pain on my R leg got worse; vomiting fainting took a nop as the day went on the pain on my R leg got worse; Symptoms of fatigue; Pain on my R knee; Went to fever 102.2 then; Chills, into the entire night/Shivers and shakes; Headache; Into the morning could not walk on my R leg/Can not walk on either foot; Numbness to my face; Found a cyst on the back of my knee; Shivers and shakes; Damage to my ligaments; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular in the left arm on 04Feb2021 at single dose for covid-19 immunisation. The patient was not pregnant. The patient medical history was none, and concomitant medications were not reported. The patient was not sure about allergies. The Patient not received other vaccine in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249), via intramuscular Left arm on 14Jan2021 04:30 PM at single dose for COVID-19 immunization (at the age of 46-years). The patient stated, "on 12Feb2021 at 03:30 PM, (as reported: one week after the second dose) after the second dose of vaccination. I started having symptoms of fatigue, pain on my R knee, went to fever 102.2 then, chills, into the entire night, headache, into the morning could not walk on my R leg, numbness to my face, vomiting fainting took a nop as the day went on the pain on my R leg got worse. Went to the ER (emergency room) x ray and ultrasound was done, found a cyst on the back of my knee not sure if it was from the shivers and shakes caused damage to my ligaments, 2 hours later my right foot was in a lot of pain, two bumps onto of my L foot lots of pain went back to the ER on Sunday morning (14Feb2021), x ray was done only no broken bones foot was red turned purplish, this started Friday 12th (12Feb2021) and her Monday the 16th Tuesday missed work and still in a lot of pain cannot walk on either foot very far without my boot or crushes." No covid prior vaccination. The patient underwent lab tests and procedures which included post vaccination sars-cov-2 test Nasal Swab: negative on 23Dec2020; body temperature: 102.2 on an unknown date; ultrasound scan and X-ray: cyst on the back of my knee on 12Feb2021, x-ray: no broken bones foot on 14Feb2021. Took the following treatment measures, shot for pain, cortisone shot, naproxen 500. The adverse events resulted in doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relation, the association between the event syncope and the vaccination with BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-03-18 | nausea |
nausea; Headache; malaise; Cold sweats; restlessness; unable to sleep; This is a spontaneous report ...
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nausea; Headache; malaise; Cold sweats; restlessness; unable to sleep; This is a spontaneous report from a non-contactable female consumer reported for herself (Non pregnant). A 46-year-old female patient received second dose BNT162B2 (Solution for injection, lot number was EL3246) via left arm on 24Feb2021, 10:30 AM, single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose BNT162B2 (lot number:EL3247) left arm on 03Feb2021, 10:30 AM at single Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. After second dose vaccination patient experienced headache, nausea, malaise, cold sweats, restlessness, unable to sleep on 24Feb2021 at 08:15 PM. The patient taking treatment 600mg ADVIL taken for all events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 46 | 2021-03-22 | abdominal pain |
Summary: Abdominal pain (similar to that experienced years previously, but not experienced approx. 2...
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Summary: Abdominal pain (similar to that experienced years previously, but not experienced approx. 2 years previous to Pfizer COVID-21 vaccination) recurred after first vaccination, worsened after second vaccination, leading to 2 ER admission and hospital admission. Ultimate cause still not determined or successfully treated; pain continues treated by opoids, gabapentin, anti-nausea medication. Patient has not been able to work since March 4th, 2021 (currently March 23rd, 2021). Details: The day after the first vaccination, abdominal pain similar to that the patient had previously experienced, but which had not presented severely for around a two years, recurred quite severely for 4-5 days. Missed 2 days of work. Pain reduced enough to resume work after 4-5 days. The day after the second vaccine dosage (2 Feb 2021), the abdominal pain worsened again, becoming more severe and more prolonged than after the first dosage. Missed four days of work (not consecutive). Pain worsened. 12 March 2021 visited PCP, who recommended immediate ER/hospital admittance. ER could not any definite cause of pain (though 8cm fibroid present, thought to be causing lower abdominal pain but not upper abdominal) and released patient. Abdominal pain became somewhat better but still continued. March 6th, abdominal pain greatly increased, leading to ER visit and hospital admittance March 6th-March 9th, 2021. CT scan 6 March 2021. Relevant results: Bowel: Multiple dilated loops of distal small bowel with fecalization of small bowel contents and a slow transition to normal caliber at the terminal ileum. The appendix is not visualized. The stomach is unremarkable. The colon is not dilated. Mesentery/Peritoneum: Small indeterminate density fluid adjacent to dilated loops of bowel in the right lower quadrant. Nodes: Scattered small abdominal nodes, none meeting CT criteria for pathologic enlargement. Pelvis: Large uterine leiomyoma. Uterine fibroid identified as probably source of pelvic and lower abdominal pain. Mid and upper abdominal pain thought not to be related, however, and may be related to dilated loops of distal small bowel and adjacent fluid. Pain treated with opoids, gabapentin, anti-nausea drugs, patient released 9 March 2021. Abdominal pain continues, partially controlled with pain medications. Lower pelvic pain has not recurred (birth control pills started at end of hospital visit). Patient has been been able to work since March 4th (currently March 23rd, 2021). Patient is applying for short-term disability due to extended absence from work caused by these issues.
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| 46 | 2021-03-28 | nausea |
The second day after injection temperature dropped to 93.7; I was very cold; I was dizzy almost pass...
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The second day after injection temperature dropped to 93.7; I was very cold; I was dizzy almost passed out; tired; nausea; headache; almost passed out; Hypertension/BP 155/103; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6203, expiry date not reported) via an unspecified route of administration, administered in left arm on 04Mar2021 at a single dose for COVID-19 immunisation. Medical history included interstitial cystitis and endometriosis, known allergies to milk and sulfa, have had a complete hysterectomy, and patient was getting hormone injections. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior to vaccination. Concomitant medications were unspecified; it was reported that patient had other medications in two weeks. The patient previously took ibuprofen and experienced known allergies; and had first dose of bnt162b2 for covid-19 immunisation on an unknown date. The patient had no other vaccine in four weeks. The second day after injection (06Mar2021), temperature dropped to 93.7, BP 155/103, and patient was very cold. Patient was dizzy, almost passed out (Mar2021). Patient temp ran from 97 to 98 and was able to get temp up to 95 (2021) but it's been there and dropping to 94.9 since 06Mar2021. Patient did have hypertension BP but take meds for it (Mar2021). Patient was also very tired, nausea and headache on and off (Mar2021). But all those have been reported. It's not normal for the patient to be cold because patient have had a complete hysterectomy and was getting hormone injections. Therapeutic measures were taken as a result of the event hypertension. No treatment received for the other events reported. The patient was not tested for covid post vaccination. The outcome of the events was not recovered.
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| 46 | 2021-03-30 | vomiting |
intractable vomiting; severe unusual for her headache; This is a spontaneous report from a contactab...
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intractable vomiting; severe unusual for her headache; This is a spontaneous report from a contactable physician. A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 04Mar2021 14:00 (Batch/Lot number was not reported), at the age of 46-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. There were no concomitant medications. The patient is not pregnant at the time of vaccination. The patient did not have COVID prior vaccination. On 11Mar2021, patient developed intractable vomiting and was not able to keep any fluid down for 24h. She had no any other symptoms at that time and no fever or headache. After her vomiting was stopped with high dose of Zofran, she developed severe unusual for her headache that lasted 2 days. The events required physician office visit. The events were assessed as life-threatening by the physician. MRI was done and it was normal. The patient has fully recovered and has no any residual symptoms. Interesting, that patient has a physically and mentally disable son that developed encephalitis at age 4month unclear etiology. No reason for his encephalitis was ever found and no virus was ever recovered. One of the versions of his encephalitis from infection disease team was post vaccinated encephalitis. The outcome of the event was recovered. The patient was not tested for COVID post vaccination. Information on lot/batch has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021301884 Same reporter, different patient/event
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| 46 | 2021-04-03 | abdominal pain, appendicitis |
4 days after receiving my first dose of the Pfizer vaccine I was admitted to the hospital with sever...
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4 days after receiving my first dose of the Pfizer vaccine I was admitted to the hospital with sever me abdominal pain and diagnosed with appendicitis. Surgery was required to remove my appendix. I had no symptoms prior to receipt of the vaccine.
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| 46 | 2021-04-07 | difficulty swallowing |
post vaccine observation session, patient complained of throat tightness/trouble swallowing and voic...
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post vaccine observation session, patient complained of throat tightness/trouble swallowing and voice became raspy. patient has multiple reported allergies and carries epipen. Received 2 doses of epi IM and one dose Benadryl prior to arrival in EC, for throat and tongue swelling again. At triage, sleepy, on transfer to floor became unresponsive and noted to be seizing (received 3 doses ativan) with no resolution, subsequently intubated for airway protection and transferred to ICU.
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| 46 | 2021-04-12 | nausea, vomiting |
Went to ER and was diagnosed with bilateral pulmonary emboli; Pain on left lung/torso/Severe pain on...
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Went to ER and was diagnosed with bilateral pulmonary emboli; Pain on left lung/torso/Severe pain on Left lung/torso, pain starting at collar bone down the torso; increased difficulty breathing; Vomiting; fever 99.2/fever 99.6; Tired; Nausea; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER 8727), via an unspecified route of administration, at the age of 46 years, administered on the left arm on 23Mar2021 10:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to PCN from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC) and fluoxetine (FLUOXETINE); both taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicilin and experienced drug hypersensitivity. The patient went to ER and was diagnosed with bilateral pulmonary emboli on 23Mar2021 21:30, pain on left lung/torso/severe pain on left lung/torso, pain starting at collar bone down the torso on 23Mar2021 21:30, increased difficulty breathing on 23Mar2021 21:30, nausea, vomiting, fever 99.2/ 99.6, tired on 23Mar2021 21:30. The patient underwent lab tests and procedures which included body temperature: 99.2 on Mar2021, body temperature: 99.6 on Mar2021, sars-cov-2 test: negative on 01Apr2021. Therapeutic measures (Eliquis (blood thinners)) were taken as a result of the events. The events were reported as Life threatening. The outcome of the events was recovering.
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| 46 | 2021-04-13 | diarrhea, abdominal pain upper |
High heart rate (140-150) while sitting. High Blood Pressure (150/90) while sitting. Left side chest...
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High heart rate (140-150) while sitting. High Blood Pressure (150/90) while sitting. Left side chest pain. Heart palpitations. Welt at injection site, was painful and itchy. Stomach cramping and loose stool.
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| 46 | 2021-04-17 | appendicitis |
appendicitis; This is a spontaneous report from a contactable consumer (patient). This consumer repo...
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appendicitis; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 27Mar2021 at 16:30 (batch/lot number: ER 870) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unspecified date. The patient was not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID) and drospirenone (SLYND); both taken for an unspecified indication, start and stop date were not reported. Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. On 31Mar2021 at 12:00 AM, 4 days after receiving the first Pfizer shot, the patient was hospitalized with severe abdominal pain and diagnosed with appendicitis. A day later, she had surgery to remove her appendix. The woman in the hospital bed next to her had received the same shot on the same day and was hospitalized at the same time as her with the same diagnosis and surgery. The adverse event resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for appendicitis from 31Mar2021 to 03Apr2021 for 3 days. No Covid prior to vaccination and was Covid tested post vaccination. Covid test post vaccination included nasal swab on 31Mar2021 with negative result. Therapeutic measures were taken as a result of appendicitis which included appendectomy. The outcome of the event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021403551 same reporter, drug and event, different patient
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| 46 | 2021-04-20 | decreased appetite |
Fever, fatigue, body aches, loss of taste, loss of appetite burning at injection site immediately an...
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Fever, fatigue, body aches, loss of taste, loss of appetite burning at injection site immediately and hotness around site for three days, heaviness in chest all the way through to back, shortness of breath
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| 46 | 2021-04-20 | vomiting, nausea |
passed out and went completely unconscious; Nauseous; felt weak like someone sucked all her energy o...
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passed out and went completely unconscious; Nauseous; felt weak like someone sucked all her energy out; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 46-years-old, administered in Arm Left on 01Apr2021 13:30 (Lot Number: ER8734) as single dose for COVID-19 immunization. Medical history included ongoing High Blood Pressure, hyperthyroidism from 28Mar2021 and ongoing, allergy to Cheese and penicillin. Everyone in her family has done fine with the vaccine except her. Concomitant medications included thiamazole (METHIMAZOLE) taken for hyperthyroidism from 28Mar2021 and ongoing; atenolol, chlortalidone (ATENOLOL AND CHLORTHALIDONE) taken for hypertension from an unspecified start date and ongoing; amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing. On Thursday 01Apr2021, the patient had her first shot and she stayed for 30 minutes. After she was allowed to leave, she passed out and went completely unconscious and she was rushed to the ER. She sat for the 30 minutes, then got to her car and it took 10 minutes to get to department store and with in 7 minutes of being at department store she started feeling nauseous then came the fatigue and she felt nauseous and felt like she was going to pass out so she sat down, she didn't know what was going on. It started with her feeling nauseous and then she started to feel weak like someone sucked all her energy out. She states in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills. The EMS took her to the ER. The adverse events occurred on 01Apr2021 14:30 (as reported). The ER let her go home Thursday night. They gave her an IV and did lab work and the lab work came back fine. It was a combination of her meds and the vaccine or it was just the vaccine. Her primary doctor said it was the vaccine. She is scheduled 22Apr2021 for her second one and she is calling to see if there is any advice or anything she needed to do for the second shot. Her doctor told her that when she takes it, she needs to be close to the ER so a doctor can monitor her. Treatment for events included IV fluids to help from being dehydrated and throwing up, Emergency Room, possibly Benadryl. The events required a visit to Emergency Room on 01Apr2021 and to the Physician Office on 05Apr2021. The outcome of the events passed out and went completely unconscious and felt weak like someone sucked all her energy out was recovered on 02Apr2021 while for the rest of the events was recovered on 01Apr2021. The events were considered as serious (medically significant). No Prior Vaccinations (within 4 weeks), no adverse events following prior vaccinations. Information on Lot/Batch number was available. Additional information has been requested.
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| 46 | 2021-04-27 | diarrhea |
Anaphylactic reaction; a lot of "brain fog"; Diarrhea; Her hip pain has gotten progressively worse; ...
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Anaphylactic reaction; a lot of "brain fog"; Diarrhea; Her hip pain has gotten progressively worse; This is a spontaneous report from a contactable consumer via Program. The 46-years-old female consumer (patient) received BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown,) on 19Mar2021 via an unspecified route of administration as a single dose for COVID-19 immunization. The medical history and concomitant medication were not reported. The other medication included XELJANZ XR TAB 11MG since 28Jul2020. Patient reported that she had an anaphylactic reaction to her first Pfizer COVID-19 vaccine on 19Mar2021. Since this reaction she has had a lot of brain fog and diarrhea, that was not happening before the reaction. Patient also said that her hip pain has gotten progressively worse and affecting her ability to dress herself. Further patient explained she will miss 2 doses of Xeljanz before she receives the medication on 15Apr2021. The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 46 | 2021-04-28 | decreased appetite |
Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensi...
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Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensitivity to lights and sounds; inability to speak; neck stiffness; vertigo; confusion; altered personality; hallucinations; memory loss; difficulty with word retrieval; migraines; recurring headaches; loss of appetite; difficulty concentrating; clumsiness; off balance; reduced speed of thought; This is a spontaneous report from a contactable consumer, reporting for herself. A 46-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EP7534), via an unspecified route of administration in the left arm on 22Mar2021 14:30 at a single dose for covid-19 immunisation. The patient received the bnt162b2 in the hospital. The medical history was not reported. There were no allergies. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN) taken for an unspecified indication, start and stop date were not reported. On 25Mar2021 at 16:00, the patient experienced drowsiness, sensitivity to lights and sounds, inability to speak, neck stiffness, uncharacteristic behavior/ not aware of behavior, confusion, altered personality, hallucinations, memory loss, extreme sleepiness, difficulty with word retrieval, migraines and recurring headaches, loss of appetite, difficulty concentrating, clumsiness and off balance, reduced speed of thought, and vertigo, which were serious for disability. The events required emergency room and physician office visits. Therapeutic measures were taken as a result of the events and included treatment with fluids and acetaminophen (TYLENOL). There was no covid prior to or post vaccination with bnt162b2. The clinical outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
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| 46 | 2021-04-28 | abdominal pain upper |
pulmonary embolism; pain on my stomach upper right side; difficulty breathing; This is a spontaneous...
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pulmonary embolism; pain on my stomach upper right side; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in arm left on 05Apr2021 16:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included spironolactone taken for an unspecified indication, start and stop date were not reported. On Wednesday, 07Apr2021, the patient started experiencing pain on her stomach upper right side and had difficulty breathing. Thursday, 08Apr2021 the symptoms worsened so Friday morning, 09Apr2021, she went to Urgent Care and they sent her to the hospital ER. Friday evening, 09Apr2021 she has been admitted to the hospital with pulmonary embolism. She was released from the hospital on Sunday, 11Apr2021. Currently taking warfarin and enoxaparin injections. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 09Apr2021. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.
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| 47 | 2020-12-31 | nausea |
Significant fatigue 24 hours after injection. Brain fog, need to sleep. Next am felt better Left arm...
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Significant fatigue 24 hours after injection. Brain fog, need to sleep. Next am felt better Left arm discomfort for week Day 4 after vaccine- nausea, mild congestion no fever Day 6 after vaccine mild congestion and significant headache
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| 47 | 2021-01-03 | difficulty swallowing |
Didn't feel "right", felt like her throat was closing, couldn't swallow, shortness of breathe, breat...
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Didn't feel "right", felt like her throat was closing, couldn't swallow, shortness of breathe, breathing got worse, called 911, 1 Epipen given, she started to cough and talk to us, then couldn't breathe again, couldn't talk, paramedics arrived.
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| 47 | 2021-01-03 | nausea |
Friday 7 AM - Extreme Dizziness, fell over 2x Extreme fatigue, general malaise, Nausea 5 pm more awa...
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Friday 7 AM - Extreme Dizziness, fell over 2x Extreme fatigue, general malaise, Nausea 5 pm more awake, dizziness subsiding Sat 10am Dizziness Subsiding, general malaise, Nausea Sun Dizziness gone, Runny Nose, Stuffiness, full/congested feeling Mon 99.5, Nausea, Drainage
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| 47 | 2021-01-03 | nausea |
Migraine with nausea and dizziness preceded by visual aura, severe left arm pain (could not raise ar...
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Migraine with nausea and dizziness preceded by visual aura, severe left arm pain (could not raise arm without significant pain), left wrist pain
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| 47 | 2021-01-03 | abdominal pain | Severe fatigue, abdominal cramping, fever 102.7 |
| 47 | 2021-01-03 | diarrhea | Temp, diarrhea for 4 hrs, malaise, bad headache , insomnia |
| 47 | 2021-01-04 | nausea |
All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My ...
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All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My left arm started swelling, it started in fore arm and it started getting marks on it; pain in arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in her right arm on 21Dec2020 at single dose for covid-19 immunization. Medical history included Blood pressure high, Attention deficit hyperactivity disorder (ADD), depression and cancer four years ago and she didn't have any left node in left arm. Concomitant medications included losartan (LOSARTAN) for Blood pressure high, venlafaxine hydrochloride (EFFEXOR) as antidepressant, tamoxifen (TAMOXIFEN) for her cancer and it was hormone blocker, lisdexamfetamine mesilate (VYVANSE) for ADD. The patient received the vaccine last this last Monday on 21Dec2020, in her right arm, she was fine, on Thursday on 24Dec2020 like all of sudden she started feeling bad, she mean it just hit her. She had fever, she was very nauseous and her arm, her left arm started swelling, it started in forearm and it started getting marks on it. Anyway she went go and got tested for Covid yesterday 26Dec2020 because in middle of night, that night I felt so bad. She have got just headache on 24Dec2020, its most of that before then. Anyways she had just got her results back that was negative but so she didn't know that her arm, it was the opposite arm. The patient still experiencing pain in arm, she haven't had fever in last night and she haven't checked it today. She took Tylenol and she called her doctor yesterday and they made of me some antibiotics for her arms, probably the 7mg and the patient guess it is every 8 hours. The outcome of the event pain in arm was not recovered and the outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-05 | nausea |
Fever; fatigue; uncontrolled headache; eye pain; chill; joint pain; nausea; This is a spontaneous re...
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Fever; fatigue; uncontrolled headache; eye pain; chill; joint pain; nausea; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the left arm on 02Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included COVID on an unspecified date. The patient's concomitant medications were not reported. The patient stated, "fever, fatigue, uncontrolled headache, eye pain, chill, joint pain. nausea. Get more worst and worst". The patient received treatment. The outcome of the events was not recovered.
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| 47 | 2021-01-06 | diarrhea, vomiting, nausea |
Headache, Arthralgia, Diarrhea, NauseaVomiting, fatigue, injection site pain Narrative: left work a...
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Headache, Arthralgia, Diarrhea, NauseaVomiting, fatigue, injection site pain Narrative: left work at noon on 12/31/20
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| 47 | 2021-01-06 | nausea, vomiting | Headache, Myalgia & NauseaVomiting |
| 47 | 2021-01-06 | nausea, vomiting | Headache, Myalgia, Fever, UrticariaPruritus, NauseaVomiting, temp 101.0 then 99.5 Chills Narrative: |
| 47 | 2021-01-06 | nausea, vomiting | Headache, Myalgia, NauseaVomiting, fever T 99.5 F |
| 47 | 2021-01-06 | nausea | Mild throat swell, nausea, blurred vision |
| 47 | 2021-01-07 | nausea, vomiting | Headache, Myalgia, Fever & NauseaVomiting Narrative: |
| 47 | 2021-01-07 | nausea, abdominal pain upper, diarrhea |
Rash on both legs; nausea; diarrhea; runny nose; epigastric pain; cough; This is a spontaneous repor...
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Rash on both legs; nausea; diarrhea; runny nose; epigastric pain; cough; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number ej1685) on 20Dec2020 13:15 at single dose intramuscularly in the left arm for COVID-19 immunization. Relevant medical history included unspecified allergies (known allergies: Yes. Allergies to medications, food, or other products: yes). There were concomitant medications. The patient experienced rash on both legs, nausea, diarrhea, runny nose, cough, epigastric pain on 20Dec2020 20:00, which resulted in emergency room/department visit or urgent care. The reporter (patient) considered the events were non-serious. It's unknown if any treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020, the patient was tested for COVID-19 (Nasal Swab) and the result was negative. The patient recovered with lasting effects.
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| 47 | 2021-01-07 | diarrhea |
Severe headache, severe body aches, skin sensitivity, fatigue and diarrhea for 18 hours then spontan...
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Severe headache, severe body aches, skin sensitivity, fatigue and diarrhea for 18 hours then spontaneously resolved
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| 47 | 2021-01-07 | difficulty swallowing |
Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside m...
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Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat. Then I began to have difficulty swallowing my saliva. And then the lump inside my throat started to feel larger and larger. By this time Dr had already injected me with Epipen and the pharmacist injected me with Solumedrol and I still felt as if I was having difficulty breathing and then I was taken to ER and I really can't remember too much after that. I was very groggy and then I was discharged from ED about 9:30 pm.
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| 47 | 2021-01-07 | diarrhea |
dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 h...
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dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 hours; itching; burning; diarrhea; redness traveling up arm into chest; This is a spontaneous report from a contactable nurse reporting for herself. A 47-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 29Dec2020 03:30 at single dose for COVID-19 immunization. Medical history included breast cancer, allergy to peanuts, dogs, cats, the outdoors. Concomitant medication included tamoxifen (unknown manufacturer). On 29Dec2020 04:00 the patient experienced dizziness, tongue and lip tingling, welt on bottom lip, chest tightness, SOB with activity for 2-4 hours, itching immediately after injection (as reported), then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. The outcome of the events was recovered. The patient received famotidine (PEPCID) and Cetirizine as treatment for the event. No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 47 | 2021-01-07 | nausea |
sore left arm swelling at injection site; 15 hours after injection:Sore left arm swelling at injecti...
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sore left arm swelling at injection site; 15 hours after injection:Sore left arm swelling at injection site; Nausea; joint pain; specifically hands wrists and neck; muscle pain; headache; fever between 102.8 and 101.3; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 11:45 am at single dose at left arm for covid-19 immunization. The patient medical history was not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took codeine and zolpidem and experienced allergies. Prior to vaccination, patient was not diagnosed with COVID-19. 15 hours after injection, patient experienced sore left arm swelling at injection site, nausea, joint pain, specifically hands wrists and neck, muscle pain, headache, fever between 102.8 and 101.3, chills on 05Jan2021 03:00 AM. Patient took covid test /Nasal Swab on 04Jan2021 and on 05Jan2021 with unknown results. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Outcome of events was not recovered. The report is considered non-serious. Information on the lot/batch number has been requested.
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| 47 | 2021-01-08 | nausea |
About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did...
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About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did not seem affected by the fatigue but my brain/head felt very "fuzzy". I had a hard time getting words out. Similar feeling to etoh intoxication. I was a bit off balance and dizzy. I remember shaking my head to try to clear it. I also had a very"plastic" taste in my mouth and felt nauseous. At the 48 hour mark (almost exactly) I felt better. At 60 hour mark brain/head symptoms completely resolved. Only experienced a very slight nauseated feeling.
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| 47 | 2021-01-08 | vomiting, nausea |
Headache & NauseaVomiting Narrative: Developed headache and nausea following administration of covi...
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Headache & NauseaVomiting Narrative: Developed headache and nausea following administration of covid vaccine. Resolved by 1/3/21.
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| 47 | 2021-01-08 | decreased appetite |
Myalgia, Fever, UrticariaPruritus, Anorexia, SOA, rhinorrhea, chills, Narrative: Self treated with B...
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Myalgia, Fever, UrticariaPruritus, Anorexia, SOA, rhinorrhea, chills, Narrative: Self treated with Benadryl and motrin
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| 47 | 2021-01-08 | nausea |
She initially developed and numbness of her face (both sides). This started in about 15 - 30 minutes...
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She initially developed and numbness of her face (both sides). This started in about 15 - 30 minutes after the vaccine and lasted about 2 hours. She had no facial muscle issues. She then developed intense vertigo and nausea. I question possible vestibular neuritis. This lasted about 5 days and was more severe the first 3-4 days. At day 7 she was almost back to normal. She also had a frontal tension style headache
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| 47 | 2021-01-09 | nausea, decreased appetite | Fever (101.9), myalgias, nausea, anorexia, headache x24 hours |
| 47 | 2021-01-10 | diarrhea |
01:45 I woke with severe soreness and ache over my entire body (8/10), chills, fever 101.5, and thro...
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01:45 I woke with severe soreness and ache over my entire body (8/10), chills, fever 101.5, and throbbing excruriating pain in the left arm (10/10). I was barely able to move the left arm, and I could not bend it due to severe pain in the elbow joint. At approximately 0800, I started having diarrhea that lasted for no more than an hour. By noon the soreness and aching had reduced to a moderate pain (5/10). I was able to bend my left arm, but the arm remained sore at the elbow joint until 01/10/2021. By the morning of 01/10/2021, all the symptoms were gone.
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| 47 | 2021-01-10 | vomiting, nausea |
72 hours of extreme fatigue. 48 hours of nausea and vomiting. 48 hours chills, aches. Ongoing headac...
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72 hours of extreme fatigue. 48 hours of nausea and vomiting. 48 hours chills, aches. Ongoing headache x5 days.
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| 47 | 2021-01-10 | diarrhea |
Bodyache , chills, Diarrhea , headache , fatigue , was tested for Covid on the 28th and was confirm...
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Bodyache , chills, Diarrhea , headache , fatigue , was tested for Covid on the 28th and was confirmed positive
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| 47 | 2021-01-10 | nausea |
Persistent headache and malaise with intermittent nausea and muscle/joint aches - began 1/4/21 and o...
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Persistent headache and malaise with intermittent nausea and muscle/joint aches - began 1/4/21 and ongoing
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| 47 | 2021-01-10 | nausea |
Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of...
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Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of warmth" come over my body and my heart rate suddenly increased to the 140's. Began to feel fullness in my throat and extremely tremulous. Nurse monitored my BP- elevated 140/101 with no hx of HTN. HR remained elevated for ~ 10 minutes than began to normalize. BP slowly began to decrease to more normal range. Tremors continued along with tingling sensation to extremities. Monitored by nurse for ~ 1 hour. Symptoms improved. Drove home. Extremely fatigued. Took dose of Benadryl. Fitful sleep with sporadic episodes of tachycardia on day #1. Following day 1/9- extreme fatigue, arm soreness, "spacey" feeling, weakness and nausea. Took additional doses of Benadryl. Slept 12 hours. Awoke on the following day ( 1/10), with persistent fatigue and nausea. Had insomnia that night and was restless, Awoke on 1/11 again with nausea, fatigue, arm soreness resolved but itchiness injection site.
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| 47 | 2021-01-10 | nausea | fatigue,nausea, body aches, head ache, chills |
| 47 | 2021-01-11 | abdominal pain upper, nausea, diarrhea |
Chills and joint pain in hips and shoulders with severe body aches occurred about 10 hours after bei...
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Chills and joint pain in hips and shoulders with severe body aches occurred about 10 hours after being vaccinated and continued to get worse over a period of 6 hours. Nausea and stomach pain also present. Diarrhea started 19 hours after being vaccinated. Body aches and diarrhea continued for a total of around 20 hours of symptoms.
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| 47 | 2021-01-11 | nausea, abdominal pain | Fever, nausea, HA, abdominal cramping |
| 47 | 2021-01-11 | abdominal pain upper, retching, nausea, diarrhea |
Morning after vaccine was sleepy with a slight headache. Went home about 16:30. Felt nauseated wi...
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Morning after vaccine was sleepy with a slight headache. Went home about 16:30. Felt nauseated with chills. Took a nap. Woke with significant chills and proceeded to dry heave for about 5 minutes. Advised to take 25mg Benadryl and also took 1 tab Advil. Symptoms resolved after about one hour. Went to bed. Following morning had stomach pain. Assumed from dry heaving, but took another 25mg Benadryl and 325mg Tylenol. Slept all day / night. Following day had diarrhea but otherwise fine.
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| 47 | 2021-01-11 | nausea | Nausea, Chills, Body Aches |
| 47 | 2021-01-11 | nausea |
body aches/aches all over her body like a fever; nausea; Pfizer COVID 19 vaccine; first dose 17Dec20...
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body aches/aches all over her body like a fever; nausea; Pfizer COVID 19 vaccine; first dose 17Dec2020; second dose 05Jan2021; dizziness; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration in the right arm on 05Jan2021 17:30 at single dose for COVID-19 immunization. Medical history included heart attack three years ago which predates treatment with the Pfizer COVID 19 vaccine. The patient's concomitant medications were not reported. The patient previous received the first dose of the Pfizer COVID 19 vaccine (first dose lot= EH9899) on 17Dec2020 at 17:30 PM in the right arm and reported no reactions to the vaccine. The patient experienced dizziness on 05Jan2021, body aches/aches all over her body like a fever, nausea on 06Jan2021. Consumer calling regarding the Pfizer COVID 19 vaccine. States she never had side effects with the first shot but the second was killing her. Clarified she received the first dose of the Pfizer COVID 19 vaccine 17Dec2020 at 17:30 PM in the right arm. She didn't have any effects after that dose. Reports she received the second dose of the Pfizer COVID 19 vaccine 05Jan2021 at 17:30 PM in the right arm. She noticed about 20 minutes after the injection on the way home, she felt dizzy had to pull over. The next morning, she continued to experience a little dizziness with nausea but states she never threw up and she had aches all over her whole body, like a really bad fever but she didn't have a fever. She was still feeling the body aches but when she gets up and walks it gets worse, like if she went to work so she stayed home today and she can still feel it a little but it is less since she is relaxing. From her vaccine card she provides the lot number for the first dose and the lot number for the second dose EK9231; does not see NDC or expiration date. The outcome of events for dizziness, nausea was resolved on 06Jan2021, for body aches/aches all over her body like a fever was not resolved. The adverse event didn't require a visit to physician office nor emergency room. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to adverse event was none. Relevant tests were none. Vaccination Facility Type: Hospital. Vaccine Administered at Facility: No.
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| 47 | 2021-01-11 | diarrhea, nausea |
tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her a...
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tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on 28Dec2020 at 0.3 mL, single for COVID-19 immunization. The patient's medical history included ventricular tachycardia from 2010 and defibrillator in her chest. There were no concomitant medications. She was scared initially so she waited for her coworkers to get the vaccine. Now, she is scared for the second dose. The night after the injection, on 28Dec2020, she had soreness in her arm. It was really bad. After two days, on 30Dec2020, she developed muscle pain, diarrhea, nausea, and headache. On Saturday (02Jan2021), she had an issue with her left eye wherein the eye lid became sore, and it got worse and worse. Her left eyelid was swollen and hurts. Now it is all swollen up. Her eye is not red. The top of the eyelid is so sore. She was really tired initially on an unspecified date. Outcome of the pain in arm and tiredness was unknown, of the swollen eyelid and eyelid pain was not recovered, of the muscle pain was recovered on 31Dec2020, while of the remaining events was recovered on an unspecified date.
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| 47 | 2021-01-11 | diarrhea |
unknown cause of diarrhea 2 days after; This is a spontaneous report from a contactable other HCP re...
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unknown cause of diarrhea 2 days after; This is a spontaneous report from a contactable other HCP reported for self. This 47-year-old female patient (Not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 29Dec2020 16:30 PM on Left arm at single dose (Lot # Ej1685) for covid-19 immunisation. Medical history was not provided. Concomitant medications included escitalopram. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history included Known allergies: may be Dilaudid. She had unknown cause of diarrhea 2 days after on 31Dec2020. Last only one day. No other symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. No treatments were received. Outcome of the event was recovered on 01Jan2021.
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| 47 | 2021-01-12 | nausea |
1327: received injection - patient said it hurt much more than 1st injection 1337: Felt dizzy, HR 79...
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1327: received injection - patient said it hurt much more than 1st injection 1337: Felt dizzy, HR 79, 125/78, O2 Sat 100%, placed supine position 1343: Felt shakey like low BG - got cookies, water, 80 HR, 128/88, 100% O2 1348: Felt like she wanted to sit up. 66 HR, 107/72, 100%, wave of dizziness and nausea 1349: HR 82, 123/86, 100% applied O2 8L Mask 1353: 92 HR 128/84, 100%, nauseated - coolw ash clothes applied - needed to transfer to a better chair that would lay back 1400: HR 72, 120/80, 100%, 36.7 - Felt warm but cool, wanted warm blankets - said she feels like she is sinking into the chair. HR 73, 118/78, 100% feeling better. 1409: 70 HR, 115/76, 100%, orthostatics taken. 1411: 69 HR 118/77, 100%, sat up 1414: 79 HR 123/87 99% took O2 off - felt ok. 1419 67 HR 121/83 100% standing felt okay, not dizzy.
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| 47 | 2021-01-12 | nausea | Chills, headache, arm pain, nausea, body aches and pain |
| 47 | 2021-01-12 | nausea | Systemic: Nausea-Medium, Systemic: flushing; symptoms lasted 1 day |
| 47 | 2021-01-12 | abdominal discomfort, nausea, diarrhea | nausea, malaise, GI upset, diarrhea; redness, swelling, warmth, pain at injection site |
| 47 | 2021-01-13 | nausea, abdominal pain upper |
12 hours after receiving the vaccine (at 11:00pm on Saturday), I woke with nausea, stomach pains and...
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12 hours after receiving the vaccine (at 11:00pm on Saturday), I woke with nausea, stomach pains and the chills. I was up the remainder of the night. By morning I had a bad headache and terrible body/muscle aches. I was unable to report to work that day. By midafternoon, the nausea and stomach pains subsided, all other symptoms remained along with then getting a 100.5 fever. I was taking Tylenol every 4 hours since 1am and keeping hydrated. By midnight I was exhausted and was finally able to sleep. I woke the following morning with a dull headache and just felt achy. I felt much better by that evening (now Monday). Tuesday morning I woke with discomfort to my left armpit and clavicle area. I then noticed swelling, the areas felt ?lumpy? and were very tender to touch. That lasted about 2 days.
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| 47 | 2021-01-13 | nausea, vomiting | Chills, nausea, vomiting, headache, neck pain. Improving. |
| 47 | 2021-01-13 | nausea |
Received 2nd dose on Friday, did not experience any issues until Monday. Began with tinnitus in lef...
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Received 2nd dose on Friday, did not experience any issues until Monday. Began with tinnitus in left ear, severe sound sensitivity, headache, then myalgia, fatigue, brain fog and disorientation, low grade fever of 99.6. Was sent home from work. Had COVID-19 testing and was negative. Worked from home the next day and still had myalgia and then had gastric issues of nausea and diarrhea, low grade fever.
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| 47 | 2021-01-13 | nausea |
Systemic: Nausea-Medium, Systemic: light headed, high blood pressure, shortness of breath-Medium; sy...
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Systemic: Nausea-Medium, Systemic: light headed, high blood pressure, shortness of breath-Medium; symptoms lasted 1 day
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| 47 | 2021-01-13 | nausea |
THREE DAYS WITH SINTOMES , PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN,CHILLES,PAIN JOINTS,FEVE...
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THREE DAYS WITH SINTOMES , PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN,CHILLES,PAIN JOINTS,FEVER,SWELLING INJECTION SITE,NAUSIAS GANGLIOR INFLAMATION.PAIN ALL HER BODY.
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| 47 | 2021-01-13 | diarrhea |
tested positive for covid/headache, ever, cough, diarrhea; tested positive for covid/headache, ever,...
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tested positive for covid/headache, ever, cough, diarrhea; tested positive for covid/headache, ever, cough, diarrhea; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, expiration date: 20Mar2021), via an unspecified route of administration on 19Dec2020 16:15 at left arm, at single dose for covid-19 immunization. Medical history included hysterectomy in 2010, pulmonary Embolism in 2010, gallbladder removed on an unknown date. There were no concomitant medications. The patient received 1st dose 19Dec2020, she was supposed to get her second dose, but tested positive for covid. She thought she had side effects after vaccine, she began with a headache, fever a week later and thought they were from the vaccine, but then her sister-in-law was positive for COVID, her sister-in-law passed away from covid virus. Then the patient, her mom, and husband tested positive for COVID. She tested positive for COVID on 27Dec2020. She developed symptoms of COVID on 27Dec2020. It was exactly one week after receiving the first dose. It was also reported that she got tested on the 30th (as reported) and received results on 31Dec2020 that she was positive. After she got sick she has taken Mucinex. Day eleven, she is doing ok, but has a little cough. No more fever. Sometimes she has diarrhea but today no diarrhea. The patient asked if she can get her second dose of the covid vaccine on day 24. The outcome of the events was recovering.
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| 47 | 2021-01-14 | abdominal discomfort |
I had fever and chill the whole day on the next day of the vaccination (01/12/2021). It started in ...
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I had fever and chill the whole day on the next day of the vaccination (01/12/2021). It started in the early morning. I took 500mg of Tylenol twice on that day to stop the fever. I had upset stomach on the following day(01/13/2021). I didn't take anything for that, just drank more water. I had back shoulder pain on the next day after the stomach upset(01/14/2021). I tried warm pack and pain patch. One symptom a day and it was last the whole day. It took three days for the symptoms to go away.
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| 47 | 2021-01-14 | abdominal discomfort | Intense headache, stomach upset, tired, sore throat |
| 47 | 2021-01-14 | nausea |
Pt experienced tachycardia and severe dizziness and associated nausea. BP 133/78, HR 94, sat 100. ...
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Pt experienced tachycardia and severe dizziness and associated nausea. BP 133/78, HR 94, sat 100. Symptoms passed after 10 minutes of observation. Sent patient home per her request.
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| 47 | 2021-01-14 | difficulty swallowing |
Within 15 minutes, I began feeling dry throat; Within 15 minutes, I began feeling dry throat, then i...
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Within 15 minutes, I began feeling dry throat; Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat.; it felt like I had a lump inside my throat.; Then I began to have difficulty swallowing my saliva.; difficulty breathing; very groggy; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), intramuscular in left arm on 20Dec2020 at a single dose for COVID-19 immunization. Vaccination was administered in a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included hypertension, overweight, and known allergies to bee stings and hair dye. The patient's concomitant medication included multivitamins. On 20Dec2020, within 15 minutes, the patient began feeling dry throat, then itching, then it felt like she had a lump inside her throat. Then she began to have difficulty swallowing her saliva. And then the lump inside her throat started to feel larger and larger. By this time, the doctor had already injected the patient with Epipen and the pharmacist injected her with Solumedrol and she still felt as if she was having difficulty breathing and then she was taken to ER and she really can't remember too much after that. The patient was very groggy and then was discharged from ED about 9:30 pm. The outcome of the events was recovered on an unknown date. Treatment for the events included epinephrine, methylprednisolone, diphenhydramine. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling dry throat, itching, felt like having lump inside her throat, having difficulty swallowing saliva, difficulty breathing and very groggy cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-01-14 | difficulty swallowing |
approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to t...
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approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to take deep breath. Severe difficulty swallowing. Difficulty getting words out, then slurring of words/poor pronouncing of words. Foggy head. Poor balance.
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| 47 | 2021-01-15 | nausea |
1st dose only side effect was sore injection site - 2nd dose- 14 minutes after injection near sync...
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1st dose only side effect was sore injection site - 2nd dose- 14 minutes after injection near syncope episode with severe dizziness, nausea, tachycardia, high blood pressure. Benadryl 50 mg was administered. 45 minutes after Benadryl administration driven home and severe dizziness was present until next morning. 17 hrs post injection had severe flu like symptoms (chills, severe headache, muscle/body aches/no fever). Took Advil 800mg. At 48hrs no symptoms remain. At 69 hrs post injection had severe dizziness that is still present at 72.5 hrs post injection.
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| 47 | 2021-01-15 | decreased appetite |
Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anor...
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Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anorexia, intermittent paresthesias, SOB, Chest Discomfort for 14 days straight, slightly better today.
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| 47 | 2021-01-16 | nausea |
Day 1- sore at injection site Day 2- sore under arm of injection arm and side of that breast. Muscle...
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Day 1- sore at injection site Day 2- sore under arm of injection arm and side of that breast. Muscles aches through mid back and chills Day 3 - Exhausted and achy, nauseous, chills, sweats Day 4- Adverse reactions gone.
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| 47 | 2021-01-16 | vomiting, nausea |
Fever 102, hr 120, decreased spo2 94, nausea, vomiting, fatigue, chills, body/joint ache, sore left ...
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Fever 102, hr 120, decreased spo2 94, nausea, vomiting, fatigue, chills, body/joint ache, sore left shoulder. Most symptoms lasted 36 hrs, nausea and fatuge lasted 48 hrs
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| 47 | 2021-01-16 | abdominal pain upper |
severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine d...
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severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine dose, extreme pain in right arm, leg, neck, and right side of the stomach started on day 2 - phone appointment with doctor , rash started on day 3 - urgent care visit, diagnosed with shingles after dermatology consult
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| 47 | 2021-01-17 | nausea |
Fever, chills, nausea, joint and muscle pain, axillary lymphadenopathy, headache, 2 days and count...
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Fever, chills, nausea, joint and muscle pain, axillary lymphadenopathy, headache, 2 days and counting
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| 47 | 2021-01-17 | abdominal pain |
I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my...
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I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my neck and back of my throat which began spreading to the back of my head . My heart felt as if I was startled by something. I looked at my smart watch and my heart rate was 145. I began trembling and having abdominal cramping . The back of my head felt like I had swelling or collection of fluid. I opened my windows and began taking slow deep breaths to bring down my heart rate . It took quite a while to get it below 100. I felt as if I was going to pass out. After deep breathing for what felt like atleasr 15 to 20 minutes , my pulse came down and I closed my windows . As soon as my body warmed back up in the car , the symptoms returned and my heart rate went back up to 130s , 140s . I had to keep my windows down and deep breathe the entire way home which took an hour . My body was trembling. When I got home I felt as if I was too week to get out of the car . I still felt that startled feeling in my heart and was afraid of what could happen next . My lips and face were swollen. My lips were also slightly itchy. I called 911 for help . By the time they arrived my vital signs had stabilized but I still had swelling in my face and lips . My EKG , vital signs and oxygen levels checked out normal so I did not go to the ER. That night I took benadryl and Tylenol. Day 2 post vaccine the collection of fluid or swelling in the back of my head had now spread to the top . That night I had the feeling that my throat was swelling do I took benadryl and Tylenol and my face and lips were still slightly swollen . Day 3 post vaccine I woke up with slightly blurry vision. The swelling in my head now feels like it has encompassed my entire head and have a slight headache. I went to the urgent care requesting an MRI of the head and an epi pen . I was given Medrol dose pack , an RX for epi pen for emergencies and advised to continue benadryl and Tylenol. Day 4 post vaccine, slight headache continues. Slightly blurry vision
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| 47 | 2021-01-17 | nausea |
Patient experienced nausea and dizziness. She was monitored for unknown amount of time and unknown ...
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Patient experienced nausea and dizziness. She was monitored for unknown amount of time and unknown disposition, but likely discharged without complication.
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| 47 | 2021-01-18 | nausea, nausea | Arm soreness, chills, sore throat, nausea, body aches, headache |
| 47 | 2021-01-18 | diarrhea | Chills, Fever of 102.6, Loose Stools, Headache, Fatigue |
| 47 | 2021-01-18 | nausea, difficulty swallowing |
Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mi...
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Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mid cheek and full face mild puffiness. Difficulty swallowing only for 5 min then sore throat since then. Nausea starting about 2 hours after. Left arm swelling and a lot of pain for a couple hours in the middle of the night and still very sore but better. Woke up with both eyes bloodshot. Feeling like my scalp was hot and tight for about a half hour but that went away.
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| 47 | 2021-01-18 | diarrhea, abdominal pain upper |
Recieved 1st dose of Covid Vaccine Lot #EH9899 on 12/22/20. Employee had tested positive for Covid ...
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Recieved 1st dose of Covid Vaccine Lot #EH9899 on 12/22/20. Employee had tested positive for Covid 7/5/20 and had recovered from severe cough. After recieving 1st dose of vaccine later that day, patient started having return of the cough. , then also had HA and leg pain. Received 2nd dose of Covid on 1/12/21 and immediately had severe stomach pain, then had diarrhea. Cough worsened the next day, developed sore throat, HA, runny nose, congestion, shortness of breath and would feel faint at times.
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| 47 | 2021-01-18 | diarrhea, vomiting, nausea | Severe Headache Fever Chills Severe Nausea Vomiting and Diarrhea Fatigue Joint/Muscle Aches |
| 47 | 2021-01-18 | nausea | Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever |
| 47 | 2021-01-18 | nausea |
fatigue; Headache; nausea; This is a spontaneous report from a contactable healthcare professional (...
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fatigue; Headache; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. lot number: EK5730), via an unspecified route of administration on 18Dec2020 10:45 in right arm at single dose for COVID-19 immunization. Medical history included Hashimotos thyroid disease and Mitral valve prolapse (MVP) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) and ferrous glycine sulfate (FE). The patient previously took Reglan iron infusions and experienced allergies. The patient experienced fatigue, headache and nausea on an unspecified date. The patient was not pregnant. The outcome of the event headache was not recovered and the outcome of the remaining events was unknown. The facility where the most recent COVID-19 vaccine was administered was in the hospital. Other medical history: hashimotos thyroid disease mvp
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| 47 | 2021-01-18 | abdominal pain, diarrhea |
fever of 102 the morning after receiving the vaccine, severe headache, severe eye pain, diarrhea, we...
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fever of 102 the morning after receiving the vaccine, severe headache, severe eye pain, diarrhea, weakness, bone pain, abdominal cramps, loose stool--that had mucous and blood in it. Also had a small amount of vaginal bleeding/spotting not associated with her period. Multiple days of these symptoms.
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| 47 | 2021-01-19 | abdominal pain upper, nausea | Bad headache, stomach cramps, nausea, dizziness for 24 hours |
| 47 | 2021-01-19 | abdominal pain upper, diarrhea |
Mild headache; Weakness; Loose stools/diarrhea; it was hard for me to walk; stomach ache/stomach cra...
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Mild headache; Weakness; Loose stools/diarrhea; it was hard for me to walk; stomach ache/stomach cramping; Fatigue; Some sweating in the middle of the night; some pain behind her eyes; Shoulder area is sore; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK4176), via an unspecified route of administration on 09Jan2021 11:00 in left arm at single dose for COVID-19 immunization. Patient take medications for mood and sleep with were very low doses. But she didn't have any medical problem. She took 10 mg of fluoxetine hydrochloride (PROZAC), 150 mg of bupropion hydrochloride (WELLBUTRIN) and 10 mg of doxepin for sleep. Yesterday after the vaccination towards the end of the day (09Jan2021 approximately 11 o' clock am), she developed a stomach ache about 5 pm and it went on throughout the night and she normally didn't have issues with her stomach. Maybe it was because she was hungry because she went ice skating with her son where they wore mask in the afternoon yesterday and she was feeling perfectly fine. But when she came home, she noticed her stomach started hurting at 5 pm and she wondered maybe it is because she was hungry. And after she ate it was still bothering her and then it got progressively worst in the middle of the night where it would wake her up periodically. But she was so fatigue that she was able to sleep still. But she noticed in the middle of the night that her stomach would wake her up because it was aching and cramping in the middle of the night. And then she also had some sweating in the middle of the night as well as some pain behind her eyes. And today (10Jan2021) she had some fatigue which she noticed was not usual, she had mild headache which she saw was a common side effect. And then in the morning (10Jan2021) some fatigue and weakness like when she walked to the bathroom it was hard for her to walk. And when she went to use the bathroom she had some loose stools which was not common for her unless at all she was sick or have eaten something that makes her stomach really sick which was very unusual for her. Her stomach was still hurting her, if she walked it will start getting cramped so she was sitting down. The only thing she toon this morning was 2 acetaminophen medicine tablets because she was having pain behind her eyes when she woke up. She was just going to say she had influenza type A and type B on several occasions. And these symptoms are similar to when she had type B influenza, which was not as difficult as type A. So this is, they seemed to be like a mild version of type B influenza which she had terrible stomach issues, diarrhea and fatigue and pain behind the eyes from type B influenza. She had not any sickness because she work from home and she had limited field contact. So, she hadn't had illness from past year now. Because she worked from home. She provided mental health counselling remotely. So, she didn't think it could be attributed from anything else. The left on arm which was up toward like shoulder area and it was sore but it was tolerable in Jan2021. Outcome of stomach ache/stomach cramping was not recovered, and outcome of other events were unknown.
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| 47 | 2021-01-19 | abdominal pain, diarrhea, abdominal pain upper |
Morning following vaccination T. 100.5. Around noon started having diarrhea. Diarrhea was severe, un...
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Morning following vaccination T. 100.5. Around noon started having diarrhea. Diarrhea was severe, unrelieved with OTC intervention. Continued for 34 hours. Temp continued thru 12/27/20. Aching, severe fatigue. Diarrhea stopped after 34 hours. Has been intermittent nearly daily since. Only occasional 24 hour periods without it. When diarrhea resumed following the 34 hour stretch, MD prescribed Lomotil. Lomotil was taken x4 days, then diarrhea stopped x2 days, then resumed again. Diarrhea continues at this time along with pain in upper stomach area, intermittent lower abdominal cramps that occur prior to episodes. Remains unable to eat normal foods r/t stomach pain and diarrhea
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| 47 | 2021-01-19 | difficulty swallowing |
Pt had vaccine at 1143, hives started at 1200, c/o itching throat at 1210 which progressed to diffic...
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Pt had vaccine at 1143, hives started at 1200, c/o itching throat at 1210 which progressed to difficulty swallowing. Epi given and pt transferred to ED
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| 47 | 2021-01-19 | decreased appetite |
Woke up at 1am with fever of 103 and unable to get out of bed due to muscle weakness. Continued with...
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Woke up at 1am with fever of 103 and unable to get out of bed due to muscle weakness. Continued with fever and chills until 7pm. Had a throbbing headache from 2pm until midnight. Severe muscle weakness and bone pain. No appetite at all. Next day still weak and sore but fever gone and about 75% better.
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| 47 | 2021-01-20 | nausea |
10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and f...
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10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and flushed and experienced mild difficulty breathing. A rapid response was called, patient noted to have a swollen and red face and neck. 0.3mg IM Epinephrin given. HR 108, SpO2 98% on room air. Patient taken to the emergency department for follow-up. In the ED patient reported feeling anxious, nauseous, and having a dry mouth. Notes that she had never had a reaction to a vaccine before. Diagnosed with an allergic reaction to the COVID-19 vaccine. Benadryl, pepcid, and Solumedrol given.
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| 47 | 2021-01-20 | abdominal distension, vomiting, abdominal pain |
For my first dose I had no significant side effects, LOT: EJ1686. ) After receiving my second dose...
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For my first dose I had no significant side effects, LOT: EJ1686. ) After receiving my second dose injection, I felt lethargic, had cold, chills with soreness to left arm. I had significant abdominal pain, my abdomen was distended and swollen. Two weeks prior to the 1st dose injection I had had abdominal surgery. I experienced peristalsis with pain with possible obstruction. I have an ileostomy., and with the vaccine I experienced (high pitched noise coming out of my stomach which caused me to vomit and fee weakness to my abdomen. i took Octeotide injection for my abdominal pain. I also took Ibuprofen for pain. My doctors said that my abdominal pain was most likely related to the injection. I went into surgery 12-14-2020 for removal of an abdominal mesh due to the ileostomy and infection. I currently can not lift no more than 10 pounds. At this time, I feel better and will be returning to work.
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| 47 | 2021-01-20 | nausea |
I felt nauseated; I experienced a severe headache the following day.; 1 dose start date 18Dec2020; 2...
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I felt nauseated; I experienced a severe headache the following day.; 1 dose start date 18Dec2020; 2 dose start date 07Jan2021; 1 dose start date 18Dec2020; 2 dose start date 07Jan2021; This is a spontaneous report from a contactable other health professional (patient). A 47-year-old female patient (pregnant: No) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number/expiration date unknown) via intramuscular on 07Jan2021 02:45 PM (vaccine location: Right arm) at a single dose for COVID-19 immunization. Previous vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number/expiration date unknown) via intramuscular on 18Dec2020 02:30 PM (vaccine location: Right arm) at a single dose for COVID-19 immunization. Medical history were not reported. The concomitant included Multi-vitamin, 2 naproxen sodium (ALEVE) the day of the 2nd dose of the vaccine (07Jan2021). No other vaccine in four weeks. Patient experienced a severe headache the following day (08Jan2021). On Saturday, 09Jan2021 patient felt nauseated. No treatment given for severe headache and nauseated. The outcome of the events, severe headache and nauseated was recovered in Jan2021. Information on lot/batch number has been requested.
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| 47 | 2021-01-20 | abdominal pain upper, diarrhea |
Numbness hands arms face and mouth and lightheaded 30 minutes post vaccine. 12 hours after vaccine 1...
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Numbness hands arms face and mouth and lightheaded 30 minutes post vaccine. 12 hours after vaccine 102 fever, severe body aches, chills, stomach ache, and diarrhea. Took acetaminophen 1000 mg at 2 am. Stomach issues subsided 7 am, 20 hours after vaccine. Fever over 101, chills, body ache, and headache remained for 3 days. All symptoms have subsided except right side of face still tingling and numb.
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| 47 | 2021-01-21 | nausea, vomiting | Fever, chills, nausea, vomited, body aches, |
| 47 | 2021-01-21 | diarrhea, retching, nausea | SEVERE NAUSEA, DIARRHEA, FEVER, CHILLS, DRY HEAVES. |
| 47 | 2021-01-22 | vomiting, nausea |
GI inflammation, nausea, vomiting x2 the evening of. The next day hives over my abdominal region wo...
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GI inflammation, nausea, vomiting x2 the evening of. The next day hives over my abdominal region worsening each day and continue to be present.
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| 47 | 2021-01-24 | vomiting, nausea |
On night on vaccination (01/22/2021), experienced headache, fever, chills, nausea, and vomiting. On ...
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On night on vaccination (01/22/2021), experienced headache, fever, chills, nausea, and vomiting. On 01/23/2021, experienced same symptoms plus dizziness and muscle aches. Vomiting subsided on 01/24/2021 at 3:00pm. Muscle aches subsided on 01/25/2021 at 10:00am. Other symptoms persist. Nausea, fatigue, and dizziness are severe.
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| 47 | 2021-01-25 | abdominal discomfort, abdominal discomfort |
47 y/o female c/o abdominal discomfort as well as facial flushing approximately 10 minutes post 2nd ...
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47 y/o female c/o abdominal discomfort as well as facial flushing approximately 10 minutes post 2nd dose of COVID 19 vaccine. Patient denied experiencing any SOB, difficulties breathing and difficulties swallowing. She described abdominal pain as sharp with sudden onset following vaccine. Patient does have a history of abdominal pain and is currently followed by GI. At that time, RN contacted provider for consult. Patient was evaluated by provider and 25 Mg PO Diphenhydramine ordered and given at 1533 Log: 502213 EXP: 3/31/21. Patient V/S at that time were: BP 144/90, HR 98, 02 99, Temp 98.1. Patient was observed by RN for an additional 15 minutes. V/S at 1545 - BP 129/79, HR 83, O2 99, temp 98.1. Pt facial flushing had visibly improved and her husband was contacted to pick up. Per provider, patient was released to self care with ER precautions provided.
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| 47 | 2021-01-25 | abdominal discomfort |
47 y/o female c/o abdominal discomfort as well as facial flushing approximately 10 minutes post 2nd ...
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47 y/o female c/o abdominal discomfort as well as facial flushing approximately 10 minutes post 2nd dose of COVID 19 vaccine. Patient denied experiencing any SOB, difficulties breathing and difficulties swallowing. She described abdominal pain as sharp with sudden onset following vaccine. Pt does have a history of abdominal pain and is currently followed by GI. At that time, RN contacted provider for consult. Patient was evaluated by provider and 25 Mg PO Diphenhydramine ordered and given at 1533 Log: 502213 EXP: 3/31/21. Pt V/S at that time were: BP 144/90, HR 98, 02 99, Temp 98.1. Patient was observed by RN for an additional 15 minutes. V/S at 1545 - BP 129/79, HR 83, O2 99, temp 98.1. Patient facial flushing had visibly improved and her husband was contacted to pick up. Per provider, patient was released to self care with ER instructions if symptoms return/worsen provided.
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| 47 | 2021-01-25 | diarrhea, nausea |
High fever; Nausea; Diarrhea; muscle/body aches; muscle/body aches; horrid headaches; large red spot...
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High fever; Nausea; Diarrhea; muscle/body aches; muscle/body aches; horrid headaches; large red spot size of softball where injection given; This is a spontaneous report from a contactable other health care professional reported that a 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection); first dose (lot number: eh9899) via an unspecified route of administration on 18Dec2020 09:00 at SINGLE DOSE at right arm, and second dose (lot number: EL1284) via an unspecified route of administration on 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included depression, anxiety, and migraine. The patient has Known allergies with lisinopril, morphine, vancomycin, albuterol. On 09Jan2021 12:00, the patient experienced High fever, nausea, diarrhea, muscle/body aches, horrid headaches, large red spot size of softball where injection given. The outcome of the events was recovering. The patient did not receive treatment for the events.
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| 47 | 2021-01-25 | vomiting, nausea |
Severe N/V for about 2 hours. It was sudden onset, then I vomited about 12 times, then I had persist...
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Severe N/V for about 2 hours. It was sudden onset, then I vomited about 12 times, then I had persistent nausea for another 12 hours. All was associated with chills and myalgia and subjective fever. Those symptoms were mild to moderate but the vomiting was severe.
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| 47 | 2021-01-25 | vomiting | Tachycardia, sweating, uncontrollable shaking, clamy hands and vomitimg |
| 47 | 2021-01-25 | nausea, diarrhea, abdominal pain upper |
Temperature 100.5-102. Swelling of all Lymph nods throughout entire body within 48 hours. EXTREME pa...
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Temperature 100.5-102. Swelling of all Lymph nods throughout entire body within 48 hours. EXTREME pain with swelling. 72 hours into time left side of body was swollen to point that clothing and jewelry do not fit. Left under arm and Breast are extra swollen *approximately triple size of right side. Migraine at 30 hours. Stomach pain in right side at 28 hours, also nausea and diarrhea.
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| 47 | 2021-01-25 | nausea |
nausea; sore throat/ throat hurt; feeling unwell; fatigue/extra tired; This is a spontaneous report ...
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nausea; sore throat/ throat hurt; feeling unwell; fatigue/extra tired; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EI1686; expiry date: unknown) intramuscular in the right arm, on 04Jan2021 at 12:00 at a single dose, for COVID-19 immunization. Medical history included diabetic/ diabetes diagnosed in 2015, high blood pressure, and high cholesterol, all prior vaccination. The patient has no relevant family history. The patient has no concomitant medications. Patient has no previous immunization with the Pfizer vaccine. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient received the first shot of the vaccine 04Jan2021 at 12:00, and she started feeling unwell during the weekend (Saturday; 09Jan2021). She's still experiencing these symptoms: fatigue, nausea, sore throat, and she's feeling worse. She called the COVID hotline because she was having fatigue and nausea. They told her to call her PCP and call Pfizer to report. After first dose on 04Jan2021, she felt ok over the weekend. She was just fatigued last night and had nausea and her throat hurts. She wanted to know about getting her second shot that is scheduled for 26Jan2021, if it is recommended or not. There was no prescriber. She received the vaccine through work clinic. She was extra tired this weekend, so Saturday would have been the start for that. She went to bed early and that was when the nausea started. It woke her up. Her throat hurt off and on through winter. But last night, it was worse than it has been. It comes and goes without any medication or anything. She was sure it was given in the muscle. NO emergency room (ER) or physician's office required. She called COVID hotline and they are making her go to the doctor before she can return to work. She has not gone yet. Outcome of the events was not recovered.
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| 47 | 2021-01-25 | nausea, diarrhea |
severe body aches; joint pain; chills; headache; nausea; diarrhea; This is spontaneous report from a...
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severe body aches; joint pain; chills; headache; nausea; diarrhea; This is spontaneous report from a contactable nurse (patient). A 47-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL3249), via an unspecified route of administration on 09Jan2021 11:15 at single dose at right arm for covid-19 immunization. Medical history included mild asthma, known allergies: latex, peanuts from an unknown date and unknown if ongoing, and the patient was diagnosed with COVID-19 prior to vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient's concomitant medications were not reported. Since the vaccination, patient had not been tested for COVID-19. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EH9899) at single dose at right arm on 19Dec2020 11:15 am for covid-19 immunization. About 12 hours after the vaccination patient had severe body aches, joint pain, chills, headache, nausea, diarrhea on 09Jan2021 09:00 PM. All symptoms lasted from 12-16 hours, except the diarrhea lasted about 20 hours. Outcome of all events was recovered on 10Jan2021. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.
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| 47 | 2021-01-26 | nausea |
Moderate Nausea, chills, fever x 2 days, extreme fatigue x 4 days, moderate ongoing injection site p...
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Moderate Nausea, chills, fever x 2 days, extreme fatigue x 4 days, moderate ongoing injection site pain. Headache.
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| 47 | 2021-01-27 | diarrhea |
Fever was 99.9; Flu symptoms; Muscle aches; runny nose; diarrhea; This is a spontaneous report from ...
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Fever was 99.9; Flu symptoms; Muscle aches; runny nose; diarrhea; This is a spontaneous report from a contactable consumer, the patient. This 47-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left arm on 13Jan2021 at 1715 (at the age of 47-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing and food allergy from an unknown date and unknown if ongoing (allergies: shell fish). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included insulin lispro (HUMALOG), insulin glargine (BASAGLAR), cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), gabapentin (GABAPENTIN). On 21Jan2021 at 11:00, 8 days later, the patient experienced fever was 99.9, flu symptoms, muscle aches, runny nose and diarrhea a couple times. Things tasted and smelled different or oddly before the senses going away. No therapeutic measures were taken as a result of the events. The clinical outcome of fever was 99.9, flu symptoms, muscle aches, runny nose and diarrhea a couple times was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 47 | 2021-01-27 | diarrhea |
for 10 days after vaccine all joints were achy, a lot of fatigue and headaches off and on with diarr...
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for 10 days after vaccine all joints were achy, a lot of fatigue and headaches off and on with diarrhea.
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| 47 | 2021-01-28 | nausea | Fever as high as 103, muscle aches, joint pain, nausea, change in smell and taste, headache, chills |
| 47 | 2021-01-28 | diarrhea, decreased appetite |
Left arm pain and stiff; left clavicular lymph node swollen and painful; temp max 101; malaise, decr...
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Left arm pain and stiff; left clavicular lymph node swollen and painful; temp max 101; malaise, decrease appetite; loose bowel movement.
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| 47 | 2021-01-29 | vomiting | VOMITED |
| 47 | 2021-01-31 | nausea |
Itchy Rash; fever; debilitating joint pain; nausea; fatigue; headache; inj site pain; This is a spon...
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Itchy Rash; fever; debilitating joint pain; nausea; fatigue; headache; inj site pain; This is a spontaneous report from a contactable other health care professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302 and expiration date was not provided), intramuscular (left arm) first dose on 14Jan2021 12:30 at single dose for covid-19 immunisation. The patient's medical history Asthma, adrenal insufficiency, hypokalemia, chronic migraine, Vit D deficiency, Known allergies: IV Contrast dye, and Covid. The patient was not pregnant at time of vaccination. The patient's concomitant medication includes unspecified drug. On 14Jan2021 13:00, the patient experienced itchy rash, fever, debilitating joint pain, nausea, fatigue, headache, and injection site pain. The patient did not received treatment for the events. The outcome of the events was recovering.
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| 47 | 2021-01-31 | diarrhea | diarrhea, fever, chills |
| 47 | 2021-02-01 | vomiting, diarrhea, nausea |
Employee reported that she had "flushing and felt very warm" for about 1 hour post Covid vaccination...
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Employee reported that she had "flushing and felt very warm" for about 1 hour post Covid vaccination at 2pm on 12/17/20. This dissipated after 1 hour. Employee then reports she "felt constipated and took some Dulcolax," and ate some food on the way home. At 1 am on 12/18, employee awoke with sore throat and began to experience intractable nausea, vomiting and diarrhea. At 5 am on 12/18, employee came to emergency department for treatment. She was given Zofran, dicyclomine and Tylenol # 3 and then discharged to home. Employee reports that nausea, vomiting, and diarrhea (with blood present), continued for several days and she was unable to work. On 12/22/20, employee still feeling ill, unable to eat with severe n/v/d. was given new prescription for Zofran as she reports she had used all of prior prescription from ER (was taking every 6-8 hrs). Employee began feeling better on 12/23/20 and returned to work. She reports she is not sure if reaction was from vaccine or not.
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| 47 | 2021-02-03 | diarrhea, nausea, difficulty swallowing, abdominal discomfort |
Immediately upon having the injection administered, my heart rate sped up. I sat down within the wai...
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Immediately upon having the injection administered, my heart rate sped up. I sat down within the waiting area for monitoring thinking that if I sat down for a bit, that it would maybe pass . Within about 7 minutes of that, I began to feel the back, left side of my throat go numb. I began to get very dizzy after that and I alerted one the pharmacy Nurses, that was on duty. She asked for me to open My mouth so that she could see if my throat was swelling & said that she didn?t see anything and I was told by her that it may just be anxiety that I was experiencing and she asked me to take a few sips of water and to try and relax a bit. She resumed helping others, while I continued to sit there. It was then when I experienced a heavy onset of chest tightness and the inability to breathe. The left side of my face and jaw went numb & that?s when I really knew something was wrong. I was taken outside for some fresh air and realize that I was so nauseous, more dizzy, very weak upon standing and I told the same nurse and another young lady that was assisting me that I felt like I was going to pass out and to please call EMS for me . At that time, I lost temporary feeling in all 4 limbs and I began to experience heart palpitations . I was having some trouble swallowing and I was laid down and. My blood pressure was taken. Blood Pressure was 235/130 and it was taken several times until emts arrived. It was then 200/120 and 180/112 by the time help arrived. Overall I experienced burning sensation in chest and abdomen, facial weakness and numbness left side fever loose stools weakness, shortness of brEath and chest tightness blurred vision felt like I?m out of touch with reality Malaise restless and the loss in feeling in my Limbs are slowly returning body And muscle and joint aches and pains and wheezing bouts
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| 47 | 2021-02-03 | diarrhea | Itchy, lightheaded, high blood pressure, seeing stars, diarrhea |
| 47 | 2021-02-03 | nausea | Nausea, body aches, chills, swollen glands, sore arm. |
| 47 | 2021-02-03 | nausea, vomiting | NauseaVomiting "Hot and cold, afebrile" Narrative: |
| 47 | 2021-02-03 | nausea |
Patient became dizzy and nauseous after receiving 2nd dose of Pfizer vaccine. Stated body felt "heav...
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Patient became dizzy and nauseous after receiving 2nd dose of Pfizer vaccine. Stated body felt "heavy" and hard to keep eyes open. Also reported feeling like heart was "racing"
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| 47 | 2021-02-03 | abdominal pain |
Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with ...
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Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination. The vaccine was administered in a Nursing Home/Senior Living Facility. Medical history included asthma and known allergies (details not provided). Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit. No treatment was given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-02-03 | difficulty swallowing |
Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressu...
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Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressure
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| 47 | 2021-02-03 | diarrhea | severe body pain, right leg numbness ,weakness and tired, diarrhea. |
| 47 | 2021-02-04 | diarrhea | Body pain Diarrhoea Numbness of right arm Weak and tired |
| 47 | 2021-02-06 | nausea |
2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing w...
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2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing with chest tightening, heart racing, numbness and tingling on my mouth and chin, tongue swollen and turned grey in a matter of a few minutes. I took Benadryl, an epinephrine pen, and a nebulizer and began to start feeling better in 15 minutes. Following the 2 weeks I felt nauseous, chills, cold sweat, lightheaded, weak, tired, headache and pain in arm/shoulder.
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| 47 | 2021-02-07 | nausea, vomiting |
Patient complained of visual changes, shakiness, N/V and fatigue. Remained in Observation Area (cli...
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Patient complained of visual changes, shakiness, N/V and fatigue. Remained in Observation Area (clinic) extended by per RN. VS assessed frequently. EMS called due to patients condition not improved but worsening and transported to ER. Patient noted similar reaction with first vaccine. Patient had COVID in September.
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| 47 | 2021-02-09 | nausea |
Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the tas...
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Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the taste and smell; Weird taste in her mouth; Headache; Swelling in her throat; Injection site pain; Muscle pain; Injection site swelling and redness; Injection site swelling and redness; Swollen lymph node; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, on 24Jan2021 at a single dose for COVID-19 immunization. Medical history included asthma from an unknown date. Concomitant medications were not reported. It was reported that the patient got the COVID-19 vaccine shot on 24Jan2021. When she sat there for 15 minutes, she got a weird taste in her mouth and got a headache. At 2 PM she still had a headache and she lost most of the taste and smell; at 4 pm she was sick to her stomach; by 5:15, her arm and head hurt badly, the taste in her mouth was like super weird but it was not exactly metallic taste it was weird bizarre taste she never had before. Her smell came back. She was extremely nauseated and had a bad headache. She stated that all of her symptoms were gone away except the swelling in her throat. She further stated she called the hospital and stated she got injection site pain, headache, and muscle pain. She also got injection site swelling and redness, nausea, swollen lymph node and a headache and the weirdest part that really bothered her was the strange taste in her mouth. She got some of the smell and taste back and now it's gone; it's really bizarre like the injection site pain, the headache everything was gone literally gone. The only things that was still hanging on was her lymph nodes and throat. The second due dose of vaccine was on 14Feb2021. The patient has not recovered from swelling in her throat and swollen lymph node, and has recovered from other events. Information on the lot/batch number has been requested.
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| 47 | 2021-02-09 | nausea |
Fatigue; headache; weakness; nausea; tingling on right side of body; This is a spontaneous report fr...
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Fatigue; headache; weakness; nausea; tingling on right side of body; This is a spontaneous report from a contactable other health professional (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (right arm) on 22Jan2021 17:30 at single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medication included lisinopril from an unspecified date for an unspecified indication. The patient previously took Codeine and Compazine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021 (13:00), the patient experienced fatigue, headache, weakness, nausea, and tingling on right side of body. There was no treatment received for the adverse event. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
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| 47 | 2021-02-09 | nausea |
Fever up to 102.5; nausea; dizziness; muscle aches; joint aches; headache; fatigue; weakness; heart ...
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Fever up to 102.5; nausea; dizziness; muscle aches; joint aches; headache; fatigue; weakness; heart rate racing; injection site pain; This is a spontaneous report from a non-contactable consumer (patient herself). A 47-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration (left arm), on 21Jan2021 16:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever up to 102.5, nausea, dizziness, muscle aches, joint aches, headache, fatigue, weakness, heart rate racing, and injection site pain - all on 22Jan2021 02:00. No treatment was received for the events. The patient had not recovered from the events at the time of the report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
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| 47 | 2021-02-09 | nausea | Headache, nausea, chills, body aches, sore joints, overall felt horrible |
| 47 | 2021-02-10 | nausea |
her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; f...
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her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; fever; her right carotid on her neck felt swollen; right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt; tired and achy; tired and achy; feeling sick; muscle and joint pain; muscle and joint pain; cough; the back of her ribs hurt; Nausea; she is having shooting pains in different spots; This is a spontaneous report from a contactable nurse reporting for self. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number EL3249, via an unspecified route of administration from 25Jan2021 14:00 (at the age of 47 years old), Dose 2, as a single dose in the left arm for COVID-19 immunization. Medical history included she had her tonsils out on an unknown date. She was a nurse that works with COVID patients; she got tested twice last week (Jan2021), both were negative. She had no pre-existing medical conditions. She has never had a problem with vaccines. There were no concomitant medications. The patient previously received dose 1 of BNT162B2 on 04Jan2021 (Lot # EX9231) and experienced no reaction then. The patient had the second dose of the Pfizer vaccine around 2 PM yesterday (25Jan2021) and she kept moving around in bed and feeling sick last night. That night she was just tired and achy but she thought that could just be from working. She went to bed early and she woke up around 1:50 or 2 AM with chills so she went and got a thermometer. She woke up at about 2 AM (26Jan2021) with a 103 fever and chills and her right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt. Her skin just burns; she went to take a shower. With the skin burning she knew it was sore to touch but when she got in the shower, that was when she noticed it hurt. She was really achy; her legs were aching and she was having shooting pains in different spots. She commented that she called out today (26Jan2021), she never calls out; all she wanted to do was take a shower and she wondered if she needed to go to the doctor. Her skin burns even when she was showering; every part her skin burns. She was also having muscle and joint pain and cough and the back of her ribs hurt (Jan2021). The other thing was nausea (Jan2021). The fever and chills were persisting and were about the same. She was hoping for it to go down so she could go to work to tomorrow (27Jan2021). The clinical outcome of the fever, chills, and her right carotid on her neck felt swollen and hurt was not recovered. The clinical outcome of feeling sick, tired and achy, face feels swollen, skin burning, muscle and joint pain, cough, back of her ribs hurt, nausea, and shooting pains in different spots was unknown. The reporter states she thinks what she is reporting was directly related to the product.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-14 | nausea |
syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours...
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syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours of vaccine /continued nausea; Fatigue; fever; chills; headache; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), via an unspecified route of administration in left arm on 27Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included very infrequent anxiety and headaches, only after illness. Concomitant medication included sertraline, ethinylestradiol, norethisterone acetate (JUNEL), fluticasone propionate (FLONASE). The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies to Compazine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration at the age of 47-year-old in left arm on 06Jan2021 10:30 at single dose for COVID-19 immunization. The patient experienced nausea within a couple of hours of vaccine. The patient experienced fatigue, fever, chills, headache, continued nausea, dizziness with 1x syncopal episode, swollen lymph nodes in left neck and left arm pit, mostly resolved after 3 days. She had still with headache. All events occurred on 27Jan2021 14:30. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the event headache was not recovered and the outcome of the other events was recovering.; Sender's Comments: Based on a compatible temporal relationship causality between event syncopal episode and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-21 | nausea, abdominal pain |
~13 hours post vaccination, symptoms consistent with acute intermittent porphyria exacerbation (atta...
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~13 hours post vaccination, symptoms consistent with acute intermittent porphyria exacerbation (attack) developed: severe abdominal pain, nausea, brain fog. Porphyria symptoms responded to porphyria-specific treatment (IV infusion with hemin (Panhematin) on both 2/10/21 and 2/11/21; analgesics). Porphyria symptoms lasted until 2/12/21. -On 2/10/21 also typical COVID-19-vaccine side effects: muscle and joint pain, fever (101.2F), chills. These resolved within one day. Previous mild COVID-19 (8 months prior to vaccination). Infection is a known trigger of porphyria attacks. Vaccination does not usually trigger porphyria symptoms.
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| 47 | 2021-02-22 | nausea |
Onset of migraine visual aura and nausea. Migraine headache did not occur while the patient was un...
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Onset of migraine visual aura and nausea. Migraine headache did not occur while the patient was under our observation. Patient thinks the aura may have been triggered by bright lights in observation room. No medications given.
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| 47 | 2021-02-23 | nausea |
Since my second vaccine I have been experiencing vertigo, lightheaded spells accompanied by nausea a...
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Since my second vaccine I have been experiencing vertigo, lightheaded spells accompanied by nausea and headache. I did not have these prior and it had now been 10 days since my second vaccine.
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| 47 | 2021-02-24 | diarrhea, nausea |
I had Covid-19 after my 1st vaccine. I experienced shortness of breath, fever, body aches, headaches...
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I had Covid-19 after my 1st vaccine. I experienced shortness of breath, fever, body aches, headaches, nausea, diarrhea, cough and also had loss of energy.
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| 47 | 2021-02-25 | nausea, diarrhea |
sweating; nauseated; really bad migraine migraine/always had migraines that usually makes her vomit,...
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sweating; nauseated; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was more diarrhea; This is a spontaneous report from a contactable consumer (patient's husband). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261 and expiry date: May2021), via intramuscular route of administration on 26Jan2021 at 11:30 at 0.3 mL, single on the left arm for COVID-19 immunization. Medical history included ongoing migraine and vomiting. Concomitant medications included ongoing sumatriptan succinate (IMITREX) for migraine, ongoing nadolol for migraine, ongoing sertraline for migraine, and ongoing ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). On 26Jan2021 at 13:00, the patient experienced really bad migraine. The patient always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea. The husband does not know if it was because of the shot or if it was because of the warm front that they are receiving because sometimes that can trigger her migraines. The husband reported that it was pretty typical for her and she will sleep with a fan on, but today she is actually covered up (for clarification) and does not want the fan on. Patient also started sweating and got nauseated on an unspecified date. The husband wanted to know if he needs to take her to the doctor. The outcome of the events really bad migraine and diarrhea was not recovered while the other events was unknown.
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| 47 | 2021-02-26 | vomiting, nausea |
Pt shortly after vaccine had throat itching, skin itching, severe nausea and vomiting, respiratory d...
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Pt shortly after vaccine had throat itching, skin itching, severe nausea and vomiting, respiratory distress with coughing. Arrived in the ED with no hypoxia on room air but possible wheeze. Pt was given IM 0.3 mg of Epinephrine and IV diphenhydramine, dexamethasone, famotidine, and ondansetron. She was still vomiting and wretching and req additional ondansetron and more itching so another dose of diphenhydramine given.
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| 47 | 2021-02-27 | vomiting, nausea | nausea, vomiting, headache, fatigue |
| 47 | 2021-02-28 | nausea |
At roughly 2:30pm, started with nausea and chills, went home went to bed. Severe muscles cramping...
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At roughly 2:30pm, started with nausea and chills, went home went to bed. Severe muscles cramping and soreness. Went to ER for this was perscribed naproxen for inflammation. Still nothing helped. Went back to ER with elevated heart rate and BP due to the discomfort was accused of being a pill seeker. I just want the pain and muscle cramps to stop. I hurt from head to toe.
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| 47 | 2021-02-28 | nausea |
Patient experienced headache, fatigue, muscle aches, joint pains, nausea, and local injection site p...
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Patient experienced headache, fatigue, muscle aches, joint pains, nausea, and local injection site pain
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| 47 | 2021-02-28 | difficulty swallowing, nausea |
Perfectly fine until about 25 minutes after the injection. Then, nausea and dizziness started, foll...
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Perfectly fine until about 25 minutes after the injection. Then, nausea and dizziness started, followed by burning and itching on both sides of tongue. Then the back of the throat started hurting, and it became hard to swallow, followed by becoming very cold, chills, and dry mouth. Finally the skin area around mouth and lips and up through the cheek/jawline became very itchy. It was not anaphylaxis because my breathing was okay. We drove home, and I took two Benedryl (50 mg) upon arriving home. Within 2 hours all symptoms subsided with the exception of a nasty headache. Today, I am fine, but just have a sore arm at the site.
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| 47 | 2021-03-02 | nausea |
extreme chills, nausea, chest pain, shortness of breath, fever of 104.3 that would only come down to...
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extreme chills, nausea, chest pain, shortness of breath, fever of 104.3 that would only come down to 103 with alternating Tylenol and Ibuprofen, body aches, lasted 3 days
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| 47 | 2021-03-07 | vomiting, nausea |
very bad headache; nausea; muscle aches; fatigue; vomited; This is a spontaneous report from a conta...
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very bad headache; nausea; muscle aches; fatigue; vomited; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 20Jan2021 at 12:15 at a single dose in the right arm for COVID-19 immunization. The patient's medical history was reported as none. Concomitant medications included bupropion hydrochloride (BUPROPION HCL XL) and topiramate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 21Jan2021 at 08:00, the patient experienced very bad headache, nausea, muscle aches, and fatigue. The patient also vomited on 21Jan2021 at 08:00. The patient took Tylenol as instructed by her doctor and rested. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 47 | 2021-03-09 | retching |
Throat scratchy, dry heaving, throat closed, needed epi pen, went to Er, had second episode, over...
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Throat scratchy, dry heaving, throat closed, needed epi pen, went to Er, had second episode, overnight in hospital with body aches, headache, had third episode in the morning 24 hrs after injection
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| 47 | 2021-03-15 | nausea |
Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; Felling Dizzy; Disoriented, Could not finish...
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Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; Felling Dizzy; Disoriented, Could not finish the drive home due to disorientation; Emotional; Crying; Nausea; Tired; Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 04Feb2021 10:30 am at a single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 on 12Jan2021 (at 04:30 PM, Right arm, dose 1) for covid-19 immunisation. The patient experienced felling dizzy (dizziness), disoriented, could not finish the drive home due to disorientation (disorientation), emotional (emotional disorder), crying, nausea, tired (fatigue); all on 04Feb2021 11:00 am and Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM (inappropriate schedule of product administration) on an unspecified date and (off label use) on 04Feb2021 10:30 am. No treatment received for the adverse events (felling dizzy, disoriented, could not finish the drive home due to disorientation, emotional, crying, nausea and tired). All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM (inappropriate schedule of product administration) and (off label use) was unknown and for all events, not recovered.
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| 47 | 2021-03-24 | nausea, abdominal discomfort |
Stomach upset; Mid back hurting; Metallic taste mouth; Nausea; This is a spontaneous report from a c...
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Stomach upset; Mid back hurting; Metallic taste mouth; Nausea; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in arm left on 09Mar2021 at 07:58 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing gastrooesophageal reflux disease (GERD) and ongoing allergies from an unknown date. Concomitant medications included lansoprazole (PREVACID) taken for gastrooesophageal reflux disease, start and stop date were not reported. The patient got her first dose of the vaccine yesterday (09Mar2021) and immediately when she was given the injection, she had a metallic taste in her mouth. This lasted 10-15 minutes. She added, she has allergies and she told them that when getting the vaccine. She was told to sit for 30 minutes. She actually sat for 45 minutes instead, but that went away. She later clarified she was referring to the metallic taste that went away. She also had nausea throughout the day. Last night, she took medicine for acid reflux because she has GERD and had stomach upset from the nausea. She clarified she took PEPCID. Then after that, she noticed her mid back was hurting. She is not sure if this is considered a muscle ache, did not really feel like a muscle ache, but it was like a burning type of pain. This was in her mid-back area. It would like to start on one side and rotate to the other and go back and forth. She sent an email to the doctor. She is the one who suggested she get the vaccine because at first, she was not going to get it. The doctor talked her into it. Metallic taste in mouth she did not have after leaving the area. It was a different taste. She was unable to clarify outcome. It was just something she noticed. Nausea: Commented she also take lansoprazole (PREVACID) every day. Last night, she took PEPCID. From what she can tell this morning she has not had nausea. However, she has not gone through the full day yet so would say it's still ongoing, but better. PEPCID (Lot: MHF063, Exp: Mar2021) at 20mg tablet, as needed, for stomach upset. She commented she does not know if she will take the second dose. Stomach upset seriousness criteria was confirmed as medically significant. It has gone away, but medically significant because she did not feel it until after the shot. Mid back hurting seriousness criteria was confirmed as medically significant as it is significant to her even though she is not currently getting treated for it. She still feels the ache. Yesterday, it was like a burning ache. Today it is just an ache on her right side, but still mid back. She does not know if it is a muscle ache. The outcome of the events was stomach upset was recovered on 10Mar2021, Mid back hurting and nausea was recovering, while of metallic taste mouth was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of stomach upset and back hurting due to temporal relationship. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-03-30 | abdominal pain |
it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria...
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it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria); it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); This was characterized by severe abdominal pain; headache; extreme dizziness; chest pain; brain fog; numbness in feet; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (not pregnant) received bnt162b2, via an unspecified route of administration, in left arm on 03Mar2021 09:00 (second dose, Batch/Lot Number: EN6203), via an unspecified route of administration in left arm on 09Feb2021 12:45 (first dose, Lot number: EC(L?)8982) both as single dose for covid-19 immunization. Medical history included acute intermittent porphyria, migraine, hypertension (HTN), dermatitis contact (Known allergies: adhesives (contact dermatitis)), COVID-19 (If COVID prior vaccination: Yes) all from unknown date and unknown if ongoing. Concomitant medications included givosiran sodium (GIVLAARI); lisinopril; hemin (PANHEMATIN DRY); zolmitriptan taken for an unspecified indication, start and stop date were not reported. The patient experienced after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain), it triggered an exacerbation (attack) of her underlying genetic disease (acute intermittent porphyria), this was characterized by severe abdominal pain, headache, extreme dizziness, chest pain, brain fog, numbness in feet all on 03Mar2021 20:00. After each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain) and it triggered an exacerbation (attack) of her underlying genetic disease (acute intermittent porphyria). This was characterized by severe abdominal pain, headache, extreme dizziness, chest pain, brain fog, numbness in feet. She received treatment for the attack and symptoms resolved after several days. The treatment included: Intravenous treatment with hemin (PANHEMATIN). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of events was resolved. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID tested post vaccination.
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| 47 | 2021-04-09 | nausea, decreased appetite |
About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up a...
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About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up as well as my hands. Then My right ankle swelled up. My face and hands had hives on them. My throat felt better, I thought but about 1/2 hr. Later I started wheezing and my right ankle and leg were swollen so, I went to the urgacare. They saw me but told me that I should've gone to the ER. I have a history of anaphylaxis. They gave me steriods and Benadryl via shots and sent me home with the same. I woke the next morning with a sore arm, a horrible headache and my face broke out into hives and was swollen again. Today is the 4th day after and my face still feels a little swollen, I have a headache and now an earache in my left ear. Today I also felt nauseous and couldn't eat.
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| 47 | 2021-04-12 | abdominal pain |
I started having left abdominal pain under my ribs (spleen and liver) on the afternoon of Friday, Ap...
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I started having left abdominal pain under my ribs (spleen and liver) on the afternoon of Friday, April 2 that lasted though Sunday, April 11. I went to the ER at 1am on Sunday, April 4 because the pain would not improve and kept me awake. I was admitted to the hospital for two days with a host of CT scans, blood work, Xray and ultrasounds for a diagnosis of splenic infarction and inflammation of the liver which I have never had before. No other clots were found, just evidence of spleenic infarction and inflammation of the spleen. Labor shows evidence of the diagnosis and I have now been put on low dose aspirin 81 for blood clot concerns and preventative by the advise of Hemotologist.
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| 47 | 2021-04-13 | decreased appetite |
hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat wa...
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hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat was starting to swell. Used Epi pen #1 . I did not get better. I felt even more on fire and my skin was hot to the touch. My tongue was really swollen and things get super fuzzy after the I might die feeling. Epi#2 Given around 5 minutes after Epipen 1. Medics took me to the ER and more rescue meds were given. I was admitted to the nuero trauma floor for 24 hrs and given meds and iv fluids. I got out the next afternoon. By the next day I was back in urgent care. They gave me meds and sent me home. By 9pm that night I was using epi#3 and going back to the ambulance. I have been to urgent care 2 times since for continued issues. I have zero appetite and my whole GI system hates me. I am alive and breathing but still feeling the impact of all of this.
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| 47 | 2021-04-21 | nausea | Headaches, muscle aches, fatigue, nausea, hard time concentrating and being able to focus |
| 47 | 2021-04-24 | nausea |
kidneys started hurting; UTI; heart pain; nausea; heart racing; blood pressure started going up; col...
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kidneys started hurting; UTI; heart pain; nausea; heart racing; blood pressure started going up; cold sweat; weak/did not have energy to talk; blood pressure was too low; This is spontaneous report from a contactable consumer reported for self. This 47-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: ER8732) at single dose in left arm on 30Mar2021 01:45 PM for COVID-19 immunization. Medical history included nephrocalcinosis. Patient had allergies to contrast of iodine, had an anaphylaxis when they injected with iodine for checking her kidney, it was over 20 years ago. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, with a minute taken the covid vaccine, patient started feeling nausea and heart racing. Her blood pressure started going up. The facility kept checking blood pressure and oxygen. After a bit, patient had no idea of time she felt a cold sweat and very weak. Patient did not have energy to talk. However, patient saw the nurse with an epi pen and she was able to tell that she was breathing. Doctor said that her blood pressure was too low. It had dropped to low 80. Patient kept trying to relax and suddenly it went all the way up again. Her normal blood pressure was 110/70 or 120/80 and it was 150/98. Patient started getting heart pain was taken to the ER and an ECG was made and her heart was ok. Her blood pressure stayed high. Patient kidney disease. Specifically, nephrocalcinosis; however, her kidney function still good. In the second day after the vaccine, on 31Mar2021, her kidneys started hurting and she felt like she was having an UTI (urinary tract infection) what she did not have had in the last year or so. All the adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for all events was reported as unknown. The outcome of events was resolving.
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| 47 | 2021-04-26 | vomiting |
diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/...
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diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/swollen glands; swollen injection site; tired; mouth ulcers; extreme nerve pain; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 08Apr2021 15:00 (Batch/Lot number was not reported) at single dose (at the age of 47 years old) for COVID-19 immunisation. Medical history included "if covid prior vaccination: Yes". Concomitant medications included potassium, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cetirizine and chlorthalidone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 for COVID-19 immunisation. The patient reported, "fever, muscle aches, headache, throwing up, chills, swollen lymph nodes, swollen injection site, tired. After chills, fever, throwing up, mouth ulcers. On day 7 I have extreme nerve pain, swollen glands, and paralysis on left side of face. Went to DR and they diagnosed with Bells Palsy. Left side of face does not move at all", 09Apr2021 09:00. The patient received no treatment. The outcome of bells palsy, extreme nerve pain, mouth ulcers and swollen lymph nodes/ swollen glands were not recovered and other events was recovering. Information about lot/batch number has been requested.
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| 47 | 2021-04-28 | diarrhea, nausea |
faint; Dizziness; Nauseous; diarrhea; Tight throat; This is a spontaneous report from a contactable ...
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faint; Dizziness; Nauseous; diarrhea; Tight throat; This is a spontaneous report from a contactable consumer reporting for herself. A 47-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 17:15 (lot number Ew0161) on left arm at single dose for COVID-19 immunization. Medical history included Meningitis. Concomitant medications included unspecified birth control medication. The patient experienced dizziness, faint, nauseous, diarrhea and tight throat, all on 14Apr2021 17:15. All events were resulted in Emergency Room Visit. No treatment was received for the events. Lab data included Blood Test on 22Dec2020 with unknown results. The outcome of the events were resolving.
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| 48 | 2020-12-31 | nausea |
Pt felt dizzy and nauseous after vaccine administration. When she tried to get up, she experienced s...
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Pt felt dizzy and nauseous after vaccine administration. When she tried to get up, she experienced syncope for about one minute. We administered Epi-pen and pt regain consciousness. Asked facility and patient if 911 call was needed, but patient refused. We monitored her blood pressure for over 1 hours and she stabilized at her baseline. We released her to go home and she will continue to monitor other potential adverse reactions.
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| 48 | 2021-01-04 | abdominal pain |
I was diagnosed with shingles on my left side on 12/31/2020, with symptoms (burning/skin sensitivity...
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I was diagnosed with shingles on my left side on 12/31/2020, with symptoms (burning/skin sensitivity on my back (probably on 12/27, definitely by 12/28 progressing to waves of pain in my back to abdomen). On 12/30, a rash appeared on my abdomen starting below my navel and going around my left side to about an inch before my spine. I submitted a picture and it was diagnosed as shingles via a virtual visit. It is responding to antiviral therapy, although I still have a rash and pain (but improving). I did not go through the COVID vaccine side effect virtual visit route because I did not really think it was a side effect and knew I had a history of chicken pox and have been experiencing ongoing stress. The provider for the virtual visit told me to still report it for it to be investigated, but she too, thought it was likely unrelated, but still should be investigated.
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| 48 | 2021-01-04 | nausea, retching |
Patient was vaccinated at 9:21 am on 1/5/2021 after review of consent forms and questions answered. ...
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Patient was vaccinated at 9:21 am on 1/5/2021 after review of consent forms and questions answered. Patient was asked if she had any adverse reactions to vaccine or products containing polyethylene glycol ( bowel preps/ cosmetics/ lotions). Patient denied any allergies except to Penicillin. Patient consented to receive vaccine. Pfizer Covid vaccine administered at 9:21 am. No immediate reaction. Patient denied any pain at injection site. Patient escorted to observation area. At 9:30 am the patient complained of nausea and proceeded with dry heaves. Patient did state she had eaten in the morning. Patient with good radial pulses at rate of 88. Patient then stated she felt dizzy and patient was assisted to the floor and placed in a recovery position. The patient DID NOT have change in mental status or decrease in mental status. Initial BP 162/102 - HR 88. Patient continued with nausea, dry heaves and dizziness. 911 was called. Patient maintained a BP of 160-172 systolic and pulse rate of 120, RR 40. Patient WITHOUT rash, swelling, wheezing, SOB or change in LOC. Benadryl was administered at 0945. Medics arrived at 9:47. Patient was transported to local hospital. No change in patient status upon departure. Patient remained nauseated, with dry heaves and dizziness.
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| 48 | 2021-01-04 | indigestion, nausea |
Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly...
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Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly after leaving observation area (32 min in observation) 9:30 lip tingling/ numbness, headache, back soreness/tightness/ pressure continues 9:40 hearing muted, fullness/mild pressure in ears - first left then right a little later Headache waxes and wanes - at times feels like vice squeezing my head 11:50 heartburn sensation 12:00 localized swelling/ knot at injection site 12:04 wave of nausea/ mild heartburn Headache continues off and on 3:30 ear ache, nausea, stiff joints, arm/shoulder/back pain, neck pain 16:00 dizzy/ nausea 16:22 flushed feeling in cheeks and neck; itchy cheeks, neck, chest 16:50 still flushed, itchy all over, heart palpitations. Fitbit shows HR 78 Hives for several hours. Hives gone by morning but still intermittently itchy. Eyes itchy/ feels like a contact lens is stuck in a wrong spot (have not worn contacts in 12+ years) Very mild cough started in evening 12/19 Hives in afternoon; itching off and on all day HR 91 (21:30) 21:43 HR 97 dizziness, headache 22:00 hives on face and abdomen 23:09 eye hurts again and is so itchy I want to rip it out of the socket, headache persists 12/20 Mild-to moderate itchiness upon waking, Itchiness off and an Mild headache off and on 9:15 heaviness in chest - feel I like do just before I get bronchitis, very mild cough Itchiness throughout the day. Hives on face in evening/Skin has a sunburn-type feeing Hives on neck and chest at bedtime Eyes itching then hurting - feels almost like pink eye type sensation As I was dozing off to sleep, heart palpitations - HR 97 12/21 Itchy/ hives on face, neck, upper chest By 12/21 afternoon, itchiness and hives abated. No further symptoms
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| 48 | 2021-01-05 | nausea |
C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling i...
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C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling in nose, lips and mouth and eye lid swelling 12 hours after vaccine was given. Took Benadryl at 2230 and again at 12/29 0430. Called us to report s/s at 10:30 on 12/29. States symptoms are subsiding but still has eyelid swelling. Told to follow up with PCP.
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| 48 | 2021-01-05 | nausea | Chills, shivering , body aches, nausea, fatigue, extreme pain and tenderness at the injection site |
| 48 | 2021-01-05 | nausea, nausea | Chills/shivering, body aches, nausea, fatigue, extreme pain and tenderness at the injection site |
| 48 | 2021-01-05 | vomiting, diarrhea |
Fever, dizziness / light headedness, servere muscle aches, vomiting, diarrhea, sore throat, like ...
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Fever, dizziness / light headedness, servere muscle aches, vomiting, diarrhea, sore throat, like I got a servere flu
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| 48 | 2021-01-05 | abdominal discomfort, nausea |
Started on 4th day, around 3 am, woke up with severe muscle aches, extensive lower back pain(unable...
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Started on 4th day, around 3 am, woke up with severe muscle aches, extensive lower back pain(unable to walk properly), dizziness, severe nausea. 5th day- nausea, headache, muscle aches. No fever. 6th day(today) not getting better, still very nauseous, severe headache, dizziness, stomach is upset. Symptoms dont seem to be getting better.
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| 48 | 2021-01-05 | abdominal distension |
Tested positive for COVID /she received the first dose of the vaccine last 16Dec2020 but tested posi...
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Tested positive for COVID /she received the first dose of the vaccine last 16Dec2020 but tested positive via Nasal Swab test on 24Dec2020; Tested positive for COVID/positive via Nasal Swab test/fever/body aches/headaches/She was very very weak, almost lethargic/felt really bad/fatigued; gas; bloated; the weight last week she was 167 and this week she was 180; This is a spontaneous report from a contactable nurse reporting for herself. A 48-year-old female patient received her first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) Lot #EH9899, via an unspecified route of administration on 16Dec2020 at single dose by injection in the right deltoid for COVID-19 immunisation. Medical history included borderline hypertension from 2018 and ongoing. Concomitant medication included olmesartan medoxomil (BENICAR) from 2018 and ongoing for borderline hypertension. The nurse reported that she received the first dose of the vaccine last 16Dec2020 but tested positive via Nasal Swab test on 24Dec2020. She said this kinda weird. She received the COVID vaccine on 16Dec2020. She tested positive for COVID on 24Dec2020. Obviously she was exposed to COVID prior to the vaccine. She was scheduled to have the 2nd dose on 05Jan2021 but her hospital deferred it to 23Mar2021. She was asking if this was what's recommended.She said this was another weird thing, regarding the weight last week she was 167 and this week she was 180 (in Dec2020). She was very bloated in Dec2020, it was bizarre. He husband did not receive the vaccine and had symptoms on 24Dec2020. She had normal seasonal allergy symptoms. She did not think much of it. She took her Xyzal and her normal things.She took her husband to get tested and he tested positive, so she got tested, and was positive. She worked at (address withheld), and all of her patients were immunocompromised. She was shocked. She did not think this had anything to do with the vaccine. If anything, it has helped her fight the virus.By Christmas day 25Dec2020 her fever was 102, she had body aches, she went into overdrive. She had headaches and lots of gas in Dec2020.She went into overdrive from partial recognition from the vaccine.She was very very weak, almost lethargic. Her O2 saturation have stayed good around 98% in Dec2020. She has done really well. Yesterday or the day before she felt really bad again. She did a virtual visit with (name withheld), and the doctor started her on steroids and gave her an inhaler just in case she needed it. She felt better on 30De2020. On 29De2020 she was so bad and bloated, she only had one dose of the steroids, but had unusual weight gain. Then 2 pounds were gone this morning on 30De2020.She had no pitting edema or edema period. She was very fatigued, but had more energy this morning, probably because of the steroids. She had the vaccine, even though day 7 post-injection, instead of day 10, which was about 50%, her body reacted more so than her husbands because her body recognized it. The outcome of the events was unknown. She was unsure of the outcome. It was up and down. She has felt worse and she has felt better. The reporter considered the event Tested positive for COVID was Not serious and unrelated to the BNT162B2.; Sender's Comments: While reporter causality is noted, a possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.
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| 48 | 2021-01-05 | nausea |
fever 100 - 102, body aches, chills, sever nighttime sweating, intermittent nausea, severe headache...
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fever 100 - 102, body aches, chills, sever nighttime sweating, intermittent nausea, severe headache, fatigue, face feeling flush for 48hours beginning approximately 3 hours post second vaccination treated with acetaminophen, ibuprofen, fluids and rest
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| 48 | 2021-01-05 | nausea, difficulty swallowing |
left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at...
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left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at emergency room 1330 symptoms increased. airway not obstructed. No tongue swelling reported by MD. Light red rash/flushing on chest. 25mg IV benadryl administered. IV Solumedrol administered, Vital signs stable. Cardiac monitor: regular rate and rhythm. O2 saturations 98% on room air. Symptoms improving at 1345pm. Monitored in emergency room for 1 hour. Discharged in stable condition with instructions to repeat Benadryl 8 hours after first dose if needed Throat fullness ( left side) with mild difficulty swallowing continued. Headache 5pm. Left sided face fullness/tingling: jaw, cheek. Left eye: mild swelling. 25 mg Po Benadryl taken. 01/06/21 0800 AM symptoms Left sided facial fullness/tingling continues: mild. No difficulty breathing. Left eye mild/yet decreased puffiness continues.
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| 48 | 2021-01-05 | vomiting, nausea |
severe vertigo with headache; severe vertigo with headache; nausea; vomiting; This is a spontaneous ...
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severe vertigo with headache; severe vertigo with headache; nausea; vomiting; This is a spontaneous report from a contactable health care professional nurse, the patient. A 48-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730, intramuscular in the left arm on 18Dec2020 15:00 as a single dose, for COVID-19 immunization. Medical history included Ongoing Hypertension and Migraines. Concomitant medication included hydrochlorothiazide, losartan potassium (LOSARTAN/HCT) 100/25 daily. The patient had no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 29Dec2020 06:00, the patient experienced severe vertigo with headache, nausea and vomiting. The events severe vertigo with headache, nausea and vomiting occurred on Dec 29 and Dec 30, lasted 2 days. Treatment given for severe vertigo with headache, nausea and vomiting was over the counter 'antivert/meclizine'. The clinical outcome of severe vertigo with headache, nausea and vomiting was recovered on Dec2020.
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| 48 | 2021-01-05 | nausea |
they suspect that I have rheumatoid arthritis; this is like abnormal I mean anybody with arthritis s...
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they suspect that I have rheumatoid arthritis; this is like abnormal I mean anybody with arthritis should not be a part of these trials; Never felt this kind of joint pain in my life/these are hitting my every joint in my hand, I can barely move; I have never been in as much pain in my life; I am really bad nauseous; soreness in your arm; This is a spontaneous report from a contactable consumer (patient) (Food service worker in the hospital). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. Medical history included Meniere's disease (reported 'Meniere's disease in my left ear'). The patient's concomitant medications were not reported. Consumer stated, ''I just took the COVID 19 vaccine I work at (institute name), (city name), I took it yesterday around 1 and all through the night; they suspect that I have rheumatoid arthritis I got an injection in one of my hips, my right hip and both my shoulders I can inject in cortisone injection and I have never felt this kind of joint pain in my life, I can barely move, I had been calling and I let my director know and anybody that has any kind of arthritis on these trials, I have never been in as much pain in my life and I am really bad nauseous.'' When offered for the website consumer stated, ''I just wanted to report the side effects, I am really nauseous and I can barely move; this is like abnormal I mean anybody with arthritis should not be a part of these trials.'' When probed if vaccine was prescribed by Physician, Consumer stated, ''No it was voluntary, it was not mandatory it was given my hospital administration.'' Product details for vaccine (LOT#, Expiration date, NDC#, UPC#): Consumer stated, ''EH9894, I think for the last number.'' Treatment for adverse events: Consumer stated, ''I don't have anything for nausea, I did take, they told to me take Ibuprofen my doctor said that it would help with the soreness in your arm, I take my Ibuprofen every six hours because it is prescribed to me, but I could barely move my, I can barely move; these are hitting my every joint in my hand.'' Expiry Date of Ibuprofen: 16Jul2021. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.
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| 48 | 2021-01-06 | vomiting, nausea | NauseaVomiting low back pain |
| 48 | 2021-01-06 | vomiting, nausea |
NauseaVomiting, HYPERtension, facial reddness to the chest. Went to the ER Narrative: Reports having...
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NauseaVomiting, HYPERtension, facial reddness to the chest. Went to the ER Narrative: Reports having facial redness to the chest. Had severe nausea and hypertension. Went to the ER and discharged later that day. Still having nausea today.
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| 48 | 2021-01-06 | retching, nausea |
On January 4th we were made aware of the following: A few minutes after receiving the vaccine at 8 a...
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On January 4th we were made aware of the following: A few minutes after receiving the vaccine at 8 am on 12-23-2020, the associate suffered from a severe headache 8/10, tingling sensation, BP checked Systolic in 180s, Extremely weak and tired, Severe nausea and dry heaving. Rapid response called, and associate was sent to ER. Headache 7/10. 1 gram Tylenol. Associate states ?Shaking, and I experienced delayed response when questioned by staff. 1 liter saline. Hives treated with Benedryl. In ER from 8am to 11:30am. It was determined that this was not an anaphylactic response. Associate went home with a headache 4/10. Groggy all day from Benedryl. I still have headaches constantly in frontal lobe. The headache pain Can rise from 2 / 10 to 8 /10. The constant headache is in the left frontal lobe. When the headache increases, It radiates into the temporal area as well. Dec 31, I went to Patient First. I was given Toradol IM, but the headache didn?t go away. I was given Flexeril, but it doesn?t help the pain. I am now using Excedrin to take the edge off. Associate is awaiting physician?s return call, but Dr. is out of town. Another doctor in the clinic would not see associate, as they don?t cover other physician?s patients. No fever, no respiratory symptoms.
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| 48 | 2021-01-06 | nausea |
Site injection pain (days 1-3) 12/30/2020, Days 6-present (1/6/2021-present) nausea, dizziness/heada...
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Site injection pain (days 1-3) 12/30/2020, Days 6-present (1/6/2021-present) nausea, dizziness/headaches, muscle pain, joint pain, arm weakness/unable to lift my arm, fatigue/tiredness
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| 48 | 2021-01-06 | diarrhea, nausea |
Tiredness first day after dose, second day 1/5/21 after 4PM extreme nausea, diarrhea, sore throat, a...
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Tiredness first day after dose, second day 1/5/21 after 4PM extreme nausea, diarrhea, sore throat, and some SOB or labored breathing. Felt better after 1/6/21 after 4PM.
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| 48 | 2021-01-07 | abdominal pain |
I started feeling achy (body aches) at night and took Tylenol and the next day at work I started hav...
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I started feeling achy (body aches) at night and took Tylenol and the next day at work I started having abd pain, joint pain and headache, and at home I checked my temp and it was 100.8F and my heart rate was fast, my lungs felt tight and a Tylenol and the symptoms continued for another day and gradually went away with exception of my joint pains. I also had tingling on my arms, back of my head, legs and my neck. I went to a neurologist and an allergist . My PCP does not want to make a decision about whether or not I should have the second dose before I see those.
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| 48 | 2021-01-07 | nausea |
Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, mala...
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Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, malaise, myalgia, dizziness.
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| 48 | 2021-01-07 | nausea |
about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going...
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about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going down if I didn't) cold clammy, nauseated, BP dropped, HR wnl, After about 20 mins, I felt fine. Went to work, did develop a migraine afterwards, some body ache and fatigue.
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| 48 | 2021-01-07 | diarrhea |
diarrhea; headache (HA); I felt light headed when I went to stand up and I was taken by wheelchair t...
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diarrhea; headache (HA); I felt light headed when I went to stand up and I was taken by wheelchair to the ED; my heart started racing; high blood pressure; Sinus tachycardia at 105 bpm; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EJ1685), via an unspecified route of administration on 28Dec2020 09:00 at a single dose for covid-19 immunization. The patient's medical history included allergy to fish but patient had a type of fish she was not allergic to on 01Jan2021. Concomitant medications were not reported. The patient received first vaccine on 28Dec2020 at 9:00 am. After about 5-15 minutes her heart started racing, she felt light headed when she went to stand up and patient was taken by wheelchair to the emergency department (ED). The procedures done in ED included Stat EKG which showed sinus tachycardia at 105 bpm and high blood pressure. Patient was normotensive normally. ED gave her Benedryl and pepcid. It took about 3 hours for my heartrate and BP to go back to normal in ED for 3 1/2 hours. Patient takes allergy meds everyday, allegra. The patient stated she went to bed and woke with headache (HA), (tylenol and ibuprofen were taken) lasted for 2 hours and returned the next day and patient took more ibuprofen and then it went away. The patient was allergic to fish, but she had a type of fish she was not allergic to on 01Jan2021 and had diarrhea within 30 minutes (one time occurrence). It was reported that the patient wishes to take the 2nd vaccine and has had no further adverse events. The outcome of the event was Headache (HA), heart rate increased and high blood pressure was recovered on an unknown date and unknown outcome for the remaining events.
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| 48 | 2021-01-08 | difficulty swallowing |
Elevated Heart Rate, Elevated Blood pressure (160/100), difficulty swallowing, blotching to chest an...
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Elevated Heart Rate, Elevated Blood pressure (160/100), difficulty swallowing, blotching to chest and neck
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| 48 | 2021-01-08 | abdominal distension |
Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter i...
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Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter in her chest shortly after vaccination done 12/22/20 (while being observed). States she informed staff, RNs in clinic state this employee did not report any reactions to clinic staff. Employee returned to work in ICU, states "felt better by end of day". 12/23/20 states swelling to both feet, reports 6+ (?) pitting edema. 12/24/20 states abdomen swollen. Called advice nurse who recommended she report to ED. Employee declined ED and took Benadryl instead. 12/26/20 states face swollen, joint pain, legs felt like they were on fire, could barely walk. 12/28/20 states feels better . Left foot a little swollen
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| 48 | 2021-01-08 | nausea |
Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse s...
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Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse sweating. Within 30 minutes heart rate increased and a little clearing of throat. A little over an hour nausea started and increased clearing of throat , slight feel of constricture in throat and a slight feeling of heaviness in chest, and jittery and heart rate still feels increased. Nurse at Nursing home watched for 45minutes until I chose to leave. In my vehicle and home is when nausea started. Phone call contacts with nursing home staff continued for an hour. I took 2 benadryl and 2 Tylenol, napped. Felt better. Nausea 3 days. Tired and neck lymph achy.
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| 48 | 2021-01-08 | nausea | fever chills body aches, massive headache and nausea |
| 48 | 2021-01-09 | nausea, abdominal discomfort |
Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach quea...
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Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach queasiness. HR was 156, sats were 100 % on room air. Seemed to subside after 30 minutes . However throughout the rest of the day, waves of similar symptoms recurred predominantly tachycardia and GI along with skin sensitivity. Overnight did ok, but the following morning, again re urged with sustained tachycardia at which time sought ED evaluation. Had one episode in ED with HR in 151, other vital signs maintained. Received solumedrol and Benadryl. After treatment and monitoring without recurrence, discharged home on prednisone , Benadryl. Ativan if needed.
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| 48 | 2021-01-10 | diarrhea |
6pm same day severe body ache, diarrhia, feeling chills/warmth. didn't take temp took Tylenol/Motrin...
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6pm same day severe body ache, diarrhia, feeling chills/warmth. didn't take temp took Tylenol/Motrin daily. s/s today left shoulder nerve pain (had injection on right side) 6/10. No body ache, diarrhea, chills today. COVID 1/8 test negative.
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| 48 | 2021-01-10 | nausea | Body ache, headache and nausea. |
| 48 | 2021-01-10 | difficulty swallowing |
I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt sever...
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I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt severely and I felt my throat swelling, it became increasingly difficult to swallow. My tongue felt larger and my lips and face began to feel numb. I felt flushed and I became tachycardic. It lasted about 45 seconds and then waned and then would flare again. I was able to speak and called my husband (a physician) who stayed on the phone with me while I drove to the hospital. I went straight to an outpatient unit and was given hydrocortisone IV, loratidine PO and famotidine. By the time I was on the unit, my throat only felt slightly tight with tachycardia down to 103. Following the injection of steroids, I only had one further flare of throat tightness and tachycardia that was transient lasting 30-40 seconds. Everything resolved within 40 minutes of receiving therapy. Of note, I apparently had erythema on the anterior of my neck which corresponded to the area of throat tightness.
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| 48 | 2021-01-10 | decreased appetite, nausea |
Weakness, fatigue, fever to 101, chills, muscle aches, shivers, joint pain, severe headache, nausea,...
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Weakness, fatigue, fever to 101, chills, muscle aches, shivers, joint pain, severe headache, nausea, loss of appetite lasting approximately 72 hours
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| 48 | 2021-01-11 | abdominal discomfort |
Bad headache, real tired, did not feel all that well sort of sick to my stomach. Also I could not ...
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Bad headache, real tired, did not feel all that well sort of sick to my stomach. Also I could not sleep on my left side that evening. ( that was the side I got vaccine in)
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| 48 | 2021-01-11 | nausea |
Patient describes, chills, nausea and a headache along with fatigue. Also describes flu like body ac...
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Patient describes, chills, nausea and a headache along with fatigue. Also describes flu like body aches
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| 48 | 2021-01-11 | vomiting |
Patient got Pfizer COVID-19 vaccine and had vomiting x 4 and pruritus 15 minutes after administratio...
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Patient got Pfizer COVID-19 vaccine and had vomiting x 4 and pruritus 15 minutes after administration. She was given Benadryl, Pepcid, Solumedrol with symptom relief. She did not require epinephrine.
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| 48 | 2021-01-11 | nausea | Patient reports dizziness 3 hours after getting vaccination and nausea. Dizziness has since resolved |
| 48 | 2021-01-12 | abdominal pain |
Brief but very severe abdominal pain waking me from sleep. Pain was so intense I almost passed out. ...
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Brief but very severe abdominal pain waking me from sleep. Pain was so intense I almost passed out. It restocked just as quickly, lasted 3-5 min
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| 48 | 2021-01-12 | nausea |
Fever 100 F Severe body aches Migraine type of headache Nausea and diarrhea All lasting 16 hours ...
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Fever 100 F Severe body aches Migraine type of headache Nausea and diarrhea All lasting 16 hours Still slight headache
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| 48 | 2021-01-12 | vomiting |
Fever, body aches, uncontrolled chills, chest tightness, heart palpation, dizziness, lightheaded, vo...
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Fever, body aches, uncontrolled chills, chest tightness, heart palpation, dizziness, lightheaded, vomiting, mind splitting headsche
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| 48 | 2021-01-12 | nausea |
Symptoms started mild after 14 hours after administration: body aches, after 22 hrs. I started to fe...
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Symptoms started mild after 14 hours after administration: body aches, after 22 hrs. I started to feel nauseous at first then I had chest pain, headache, chills, back pain, body aches (muscle pain) and dizziness
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| 48 | 2021-01-12 | nausea |
Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170...
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Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170/101 while lying down, heart rate 119, 100% o2 sat, difficult breathing. Patient was visibly nervous and apprehensive prior to receiving vaccine. ER via EMS. -Severe.
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| 48 | 2021-01-12 | nausea |
Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170...
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Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170/101 while lying down, heart rate 119, 100% o2 sat, difficult breathing. Patient was visibly nervous and apprehensive prior to receiving vaccine. ER via EMS.-Severe
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| 48 | 2021-01-12 | nausea, vomiting | Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Systemic: Fainting-Mild |
| 48 | 2021-01-13 | vomiting |
By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle ache...
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By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; This is a spontaneous report from a contactable nurse (patient). This 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020 09:00 at single dose in Arm Right for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Migraines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included nortriptyline, bupropion, magnesium sulfate, fish oil , ca. The patient experienced By 2am extreme headache, by 4 am vomiting, chills, to sleep till 5p, headache, chills and muscle aches on 24Dec2020 02:00 AM, Back to normal in 72 hours. The outcome was recovered. No treatment received for the adverse events. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 48 | 2021-01-13 | nausea |
Day 1-3 Injection site pain; Muscle pain; Joint pain; Headaches; Dizziness; Nausea; Unable to raise ...
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Day 1-3 Injection site pain; Muscle pain; Joint pain; Headaches; Dizziness; Nausea; Unable to raise my arm/arm weakness; Pain was at a 10 and I had to go to the ER for care; Fatigue/tiredness; This is a spontaneous report from a contactable other HCP (patient). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), on 30Dec2020 14:15 at single dose in Left arm for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Breast cancer, Hypertension (HTN), high cholesterol, lymphedema, endometriosis, hysterectomy, myomectomies x 2, anxiety, seasonal allergies, hx of pleurisy x 3. Known allergies included adhesive glue in tape and bandaids, pollen, dust, pet dander. The patient was not pregnant at the time of vaccination. Concomitant medication included escitalopram, losartan potassium 50 mg, anastrozole (ARIMIDEX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Day 1-3 Injection site pain Day 6-7-muscle pain, joint pain, headaches, dizziness, nausea, unable to raise my arm/arm weakness, pain was at a 10 and had to go to the ER for care, fatigue/tiredness. All the events were reported onset on 06Jan2021 18:00. AE resulted in Emergency room/department or urgent care. Received Morphine, Muscle relaxer, steroid via IV, RX as treatment. The events were assessed non-serious.
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| 48 | 2021-01-13 | nausea, decreased appetite |
Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covi...
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Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covid hub had me do a Covid test, negative result, continue high fever, no appetite, chills and body ache, Health Hub contacted me daily with app to review symptoms, Dec 27-29 continued symptoms, unable to eat and little bit of water intake, Dec 29 appointment made with Health Urgent Care, received text from Urgent Care cancelling appointment and instructed to take sips of water and Tylenol that I was having an immune reaction to vaccine. Dec 29 virtual appointment with PCP continued symptoms, Dec 31 repeat of COVID swab along with Flu swab both negative, Jan 2-3 hospital admission for abnormal labs, jaundice, dehydration, Sodium/Potassium and Magnesium boluses given, and work up for infectious process was negative. Discharged to home Jan 3 with low grade fever, dry mouth, dry eyes, nausea, body ache and continued loss of appetite. Jan 4-7 continued worsening jaundice and appetite with low grade fever, GI Clinic consulted at Health Clinic, PCP in daily contact, repeat liver function labs on Jan 8 showed worsening labs. Jan 9-12 afebrile, started Ursodiol, low appetite better energy, continue dry mouth, GI appointment Jan 12 with plan to repeat liver functions on Jan 15, jaundice improved and able to eat liquids. No Tylenol or antipyretic taken since Jan 3 due to liver function tests.
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| 48 | 2021-01-13 | nausea |
Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experience...
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Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experienced lightheadedness, nausea, bilateral hand tingling, hypertension after administration of her first COVID vaccination. No airway involvement. No rash, chest pain or SOB. Patient states that she thinks she had COVID in March though she tested negative. Patient has never had prior vaccine reaction. She was taken to ED, given PEPCID IV and liter of LR. Her vitals were stable throughout and she felt back to baseline and was released to go home after about 2 hrs.
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| 48 | 2021-01-13 | nausea |
pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of ...
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pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of upper extremities/tingling; sore throat; shortness of breath; anxiety; malaise; This is a spontaneous report from a contactable Nurse (patient). A 48-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: EL1284), via an unspecified route of administration in left arm on 04Jan2021 05:15 at single dose for COVID-19 immunization. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient had no Known allergies. Concomitant medication included zinc, vitamin d3, quercetin and sambucus nigra (ELDERBERRY) received within 2 weeks of vaccination. The patient reported that 12 hours after the injection she experienced severe headache, nausea, chills, temp 102, tingling of upper extremities, sore throat, shortness of breath, pressure in her chest on 04Jan2021 17:15. The fever/chills lasted about 12hrs. Chest discomfort, tingling and shortness of breath were transient (possibly anxiety related). Day 2 post vaccine in Jan2021 moderate to severe HA (headache) persisted and malaise. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 48 | 2021-01-13 | diarrhea, abdominal discomfort |
upset stomach; mild diarrhea; This is a spontaneous report from a contactable other hcp. A 48-year-o...
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upset stomach; mild diarrhea; This is a spontaneous report from a contactable other hcp. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=ej1686 and expiry date unknown, intramuscular (right arm) on 05Jan2021 14:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing and drug hypersensitivity to Cipro from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took ciprofloxacin. The patient experienced upset stomach and mild diarrhea (non-serious) on 06Jan2021 22:00. The outcome of the events was recovering.
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| 48 | 2021-01-14 | nausea |
"the next day (1/8/21) i started with a low grade temp, it never got over 100.2, now i still have ex...
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"the next day (1/8/21) i started with a low grade temp, it never got over 100.2, now i still have extreme fatigue. My arm was sore for a couple of days only. The first vaccine was on 12/17/20 and i had 11 days of nausea afterwards"
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| 48 | 2021-01-14 | nausea |
Chills, borderline rigors lasting 4 hours followed by temp of 102 (checked at 2am), took 1 GM of Tyl...
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Chills, borderline rigors lasting 4 hours followed by temp of 102 (checked at 2am), took 1 GM of Tylenol, decreased to 101 after 2 hours of taking Tylenol. Afeb at (6am 1/13/21) but increase temp again to 100.9 at 11am took 1GM of Tylenol, temp down after ~ 1 hour. Nausea and severe headache evening of 1/12/21 starting around ~ 9 pm. Nausea and severe headache lasted until 5m on 1/13/21, nausea resolved, headache improved but continued until 11 am on 1/14/21. Fatigue severe 1/13/21, improved but continued 1/14/2021, resolved by ~ 6pm on 1/14/201. Pain in axilla and groin bilaterally evening of 1/12/2021, resolved by 5am on 1/13/2021, no adenopathy. Muscle pains 1/12 until mid morning 1/13/021
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| 48 | 2021-01-14 | abdominal discomfort, diarrhea |
GI issues, severe cramping, diarrhea >10/day , dehydration, headache, tired Normal activities affec...
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GI issues, severe cramping, diarrhea >10/day , dehydration, headache, tired Normal activities affected
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| 48 | 2021-01-14 | nausea |
Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a co...
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Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a contactable Physician (Patient). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EK9231), via an unspecified route of administration on 07Jan2021 13:15 at single dose in Left arm for COVID-19 immunization. Medical history included hypothyroidism, breast cancer and severe local/regional reaction to bee sting. The patient previously took tamoxifen for breast cancer (9-10 years before 10Jan2021). There were no known allergies. Concomitant medications which the patient received within 2 weeks of vaccination included levothyroxine, tamoxifen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced uneasiness, tingling followed by tachycardia within couple of minutes, some abdominal queasiness on 07Jan2021 13:15. Heart rate (HR) was 156. Seemed to subside over a period of 30 minutes. However slow waves of similar episodes occurred throughout the rest of the day, predominantly tachycardia and Gastrointestinal tract. Next day symptoms recurred and sustained a little longer. Sought evaluation. In Emergency department (ED), Labs unremarkable. One episode in ED with HR 151. Blood pressure (BP) maintained. Electrocardiogram (EKG) showed sinus tachycardia. Treated with steroids and Benadryl. On pulse dose steroids and Benadryl with overall improvement. The events resulted in Emergency room/department or urgent care. Treatments Solumedrol and Benadryl were received for the reported events. The outcome of the events was Recovering. This case reported as non-serious.
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| 48 | 2021-01-14 | nausea, vomiting |
severe headache; severe nausea; severe vomiting; upper GI pain; tingling in hands and feet; weakness...
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severe headache; severe nausea; severe vomiting; upper GI pain; tingling in hands and feet; weakness; fever; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), via Intramuscular at single dose in the arm left, first dose on 17Dec2020 08:15, second dose on 07Jan2021 08:15, both for COVID-19 immunisation. Medical history included Epilepsy. Concomitant medications included fluvoxamine maleate (LUVOX), oxcarbazepine (OXTELLAR XR), liraglutide (SAXENDA) and bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE). On 07Jan2021 17:00, the patient experienced severe headache, severe nausea, severe vomiting, upper gi pain, tingling in hands and feet, weakness, fever. The patient underwent lab tests and procedures, which included Nasal Swab on 08Jan2021 with negative result. Therapeutic measures were taken as a result of severe nausea and severe vomiting and included treatment with Zofran. Outcome of events was recovering.
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| 48 | 2021-01-14 | abdominal discomfort |
slight headache, upset stomach, tired, muscle soreness in back and shoulders, soreness of thigh musc...
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slight headache, upset stomach, tired, muscle soreness in back and shoulders, soreness of thigh muscles. started around 5pm 1/12/2021. relieved by 1/14/2021 0800 am
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| 48 | 2021-01-15 | nausea |
I have chronic neck pain that flared up pain level (4-6 on a 1-10 scale) that lasted 4 weeks. I exp ...
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I have chronic neck pain that flared up pain level (4-6 on a 1-10 scale) that lasted 4 weeks. I exp other side effects body aches, joint pain, nausea, sore arm.
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| 48 | 2021-01-16 | nausea, diarrhea |
A metallic taste when through my mouth & got my mouth dry as soon as they where putting the vaccinat...
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A metallic taste when through my mouth & got my mouth dry as soon as they where putting the vaccination. Then I got a really bad headache & very nauseas within 5 min of getting the vaccine. I had pain on the vaccine area. I also felt very tired very exhausted about 4 or 5hrs later. I started getting chills & achiness started the next day on 12/24/2020. On 12/25/2020 I felt nauseas, still had the chills, headaches, still felt fatigue, achiness, sore throat & also had diarrhea. I had all this symptoms all the way till 12/29/2020. Seen doctor on 12/28/2020 and they decided I should get tested for Covid.
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| 48 | 2021-01-16 | nausea |
Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, t...
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Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, tachycardia.
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| 48 | 2021-01-16 | nausea | Lips tingling, tongue/throat swelling, flushed, hot flashes, leg weakness, nausea, tachypnea |
| 48 | 2021-01-16 | nausea, abdominal pain |
Severe myalgia, headache, dizziness, fatigue, nausea, GI cramping, chills for 36 hours Headache pers...
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Severe myalgia, headache, dizziness, fatigue, nausea, GI cramping, chills for 36 hours Headache persistent through today mild myalgia persistent through today
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| 48 | 2021-01-17 | decreased appetite, nausea |
Fever day after vaccine pain redness soreness at injection site body aches fatigue fever up to 102.4...
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Fever day after vaccine pain redness soreness at injection site body aches fatigue fever up to 102.4 Nausea loss of appetite headache
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| 48 | 2021-01-17 | nausea, decreased appetite |
Reporter received the Pfizer Covid-19 vaccine on Dec 28 around 7:55 am. That afternoon ~12:55, she s...
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Reporter received the Pfizer Covid-19 vaccine on Dec 28 around 7:55 am. That afternoon ~12:55, she started experiencing tachycardia. EMS was called to her home. She was evaluated and transported by car to the ER. EKG and labs were done (normal). It could not be determine if the vaccine was the cause. Dec 29th she went back to the ER for tachycardia and shortness of breath. Once again labs and EKG performed (normal). She had an appointment with a cardiologist that evening; a Holter monitor and an echo were ordered. She continued to have bouts of shortness of breath, tachycardia, muscle aches, and intermittent twitching. Went back to the ER Dec 31st
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| 48 | 2021-01-17 | nausea | nausea, head ache, dizziness, SOB, face swelling a bit |
| 48 | 2021-01-18 | nausea |
1. Nausea 2. Tremors 3. Lack of ability to speak 4. Lack of ability to sit EpiPen administered and ...
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1. Nausea 2. Tremors 3. Lack of ability to speak 4. Lack of ability to sit EpiPen administered and EMS called
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| 48 | 2021-01-18 | nausea, vomiting | Nausea, vomiting, light-headedness |
| 48 | 2021-01-18 | vomiting, nausea, abdominal pain upper |
vomiting; chills; severe headache; stomach pain x72 hrs; severe nausea; dizziness; low blood pressur...
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vomiting; chills; severe headache; stomach pain x72 hrs; severe nausea; dizziness; low blood pressure; This is a spontaneous report from a contactable healthcare professional. A 48-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular from 05Jan2021 10:00 to 05Jan2021 10:00 at a single dose for COVID-19. Medical history included asthma, sibo, allergies to wheat, gluten, corn, tomato and peanuts. The patient's concomitant medications were not reported. It was reported that the patient's initial response to shot was severe nausea and dizziness, low blood pressure lasted 24hrs on 09Jan2021. 5 days later, the patient had nausea, vomiting, chills after meal, severe headache and stomach pain 72 hrs. The patient received IV fluids as treatment for all events. The patient underwent lab tests and procedures which included Covid Nasal Swab Test on 04Jan2021 which tested negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 48 | 2021-01-19 | nausea |
10 minutes after injection, pt complained of right arm numbness, It began to spread to her throat. S...
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10 minutes after injection, pt complained of right arm numbness, It began to spread to her throat. She reported throat tightness. , nausea and dizziness. 2 MDs were in the Observation area. They assessed her, gave her 25 mg Benadryl IM and 3 puffs of Albuterol inhaler. Heart rate 110, Resp Rate 12, O2 sat 98% on room air. Pt continued to fell warm and "weird." MDs wanted her to go to hospital but pt refused. Her employer offered to drive her to the ER but she refused. The MDs remained with her, monitoring for another hour. Pt was feeling better and chose to have her husband pick her up.
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| 48 | 2021-01-19 | nausea, vomiting |
Approximately 7 hours after receiving the second dose of COVID-19 vaccine, reporter noted lightheade...
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Approximately 7 hours after receiving the second dose of COVID-19 vaccine, reporter noted lightheadedness, dizziness, mild intermittent aches and neck pain. Approximately 12-13 hours post dose, reporter developed serious systemic aches and pains, uncontrollable shaking, chills, nausea, vomiting, and developed a fever of up to 103.1. These more severe symptoms lasted approximately 3 hours and were treated with acetaminophen and ibuprofen only.
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| 48 | 2021-01-19 | abdominal pain |
Chills, Fever 100.6, Joint/Muscle Pain, Fatigue, Injection Site Arm Pain, Abdominal Pain, Unable to...
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Chills, Fever 100.6, Joint/Muscle Pain, Fatigue, Injection Site Arm Pain, Abdominal Pain, Unable to work.
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| 48 | 2021-01-19 | decreased appetite |
Chills, Muscle and joint pain, Loss of Appetite, Extreme fatigue, headache and fever (up to 103.5 ev...
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Chills, Muscle and joint pain, Loss of Appetite, Extreme fatigue, headache and fever (up to 103.5 even when on Advil). Had low grade fever up till 4 days after vaccine Fatigue has persisted a week later
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| 48 | 2021-01-19 | nausea, vomiting | Fever, body aches, nausea, vomiting, injection site pain |
| 48 | 2021-01-19 | nausea | Headache occurred, body aches, chills, nausea, and fever of 99.4 |
| 48 | 2021-01-19 | nausea |
Migraine, progressively worsening approx 2 hr after 2nd vaccine. Then chills, body aches, nausea, ex...
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Migraine, progressively worsening approx 2 hr after 2nd vaccine. Then chills, body aches, nausea, extreme fatigue. Lasted for 30 hrs. Fatigue remained another 24hrs. Felt like bad cold or mild flu. I treated with over the counter medication after my physician said that was appropriate. Still worth getting the vaccine! I?m thankful I could receive it.
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| 48 | 2021-01-19 | nausea |
SYMPTOMS STARTED MORNING OF 1/18: BODY ACHES, CHILLS. 12MD FEVER (101);2PM NAUSEA; AT NIGHT, HEADACH...
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SYMPTOMS STARTED MORNING OF 1/18: BODY ACHES, CHILLS. 12MD FEVER (101);2PM NAUSEA; AT NIGHT, HEADACHE AND NAUSEA. TUESDAY 1/19, MORNING NAUSEA. FELT BETTER TUESDAY AFTERNOON.
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| 48 | 2021-01-19 | decreased appetite, diarrhea |
diarrhea; headache; bodyache; no appetite; This is a spontaneous report from a contactable consumer ...
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diarrhea; headache; bodyache; no appetite; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not reported, expiration date: Mar2021), via an unspecified route of administration on the left arm, from 05Jan2021 at a single dose for Covid-19 immunisation. Medical history included blood pressure (abnormal). Concomitant medication included ongoing hydrochlorothiazide for blood pressure. On 06Jan2021, the patient has had body aches, headache and no appetite. On 08Jan2021, she had diarrhea. She was going to work today but was unable to because she had to run to the bathroom. She has gone to the bathroom 6 times. She called her doctor at 7:30am but has not heard back. She is unsure what to do. She is asking if these are side effects of the vaccine. She is unsure if the lot number on the card is SK4176 or PK4176. Outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 48 | 2021-01-19 | nausea |
just doesn't feel well; high blood pressure; feels like throwing up; This is a spontaneous report fr...
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just doesn't feel well; high blood pressure; feels like throwing up; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "having some high blood pressure", she "feels like throwing up" and "she doesn't feel well". The patient outcome of the events was unknown. The information on the batch number has been requested.
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| 48 | 2021-01-20 | nausea |
Fever 100.5; chills; joint pain; nausea; headache; tachycardia; shortness of breath; dizziness; pain...
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Fever 100.5; chills; joint pain; nausea; headache; tachycardia; shortness of breath; dizziness; pain & swelling at injection site and up my neck; pain & swelling at injection site and up my neck; worst patient have ever felt, felt like body had been poisoned; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686 and expiry date: unknown), via an unspecified route of administration on the left arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included heart disease, diabetes and allergies to sulfa antibiotics. Patient's concomitant medications were not reported. The patient received the first dose on 21Dec2020 (lot number: EH9899) on the left arm. The patient experienced fever 100.5, chills, joint pain, nausea, headache, tachycardia, shortness of breath, dizziness, chills, pain & swelling at injection site and up my neck, inability to lift even a water bottle without having pain on 10Jan2021. In summary it was the worst patient have ever felt, felt like body had been poisoned. Outcome of the events was recovering. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No follow up attempts are possible. No further information is expected.
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| 48 | 2021-01-20 | nausea |
Nausea; Headache; Dizziness; This is a spontaneous report from a contactable nurse. A 48-year-old fe...
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Nausea; Headache; Dizziness; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 11Jan2021 (19:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included sulfa allergy and penicillin (PCN) allergy. The patient's concomitant medications were not reported. The patient had previously received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) for COVID-19 immunization. On 12Jan2021 (11:00), the patient had nausea, headache and dizziness. The patient did not receive any treatment for the reported events. The outcome of the events, 'nausea', 'headache' and 'dizziness', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination. No follow-up attempts are possible. No further information is expected.
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| 48 | 2021-01-20 | nausea |
Severe headache; chills; body pain; intermittent nausea; extreme fatigue; brain fog; arm pain at inj...
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Severe headache; chills; body pain; intermittent nausea; extreme fatigue; brain fog; arm pain at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 48-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer BioNTech COVID VACCINE; lot number: EL3249; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 16:00 at a single dose for covid-19 immunization. Medical history included asthma, pain and allergies to sulfa drugs. Concomitant medication included montelukast sodium (SINGULAIR), estradiol, meloxicam and fexofenadine (FEXOFENADINE). The patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer BioNTech COVID VACCINE; lot number: EJ1685) via an unspecified route of administration left arm on 19Dec2020 04:45 PM at a single dose for covid-19 immunization. The patient has not received other vaccines in four weeks. The received her vaccine in a hospital. On 08Jan2021 5:30 PM, the patient experienced severe headache chills, body pain, intermittent nausea, extreme fatigue, brain fog and arm pain at injection site. No treatment was received from the adverse events. The patient was not diagnosed with Covid prior to vaccination and has not been tested for Covid post vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 48 | 2021-01-21 | nausea | Extreme nausea, dizziness, decrease in blood pressure |
| 48 | 2021-01-21 | difficulty swallowing |
Within 2-3 minutes felt sensation of throat closing up and difficulty swallowing. Went to ED within...
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Within 2-3 minutes felt sensation of throat closing up and difficulty swallowing. Went to ED within 10 minutes and was treated with EPI, Pepcid, Decadron, Ativan and IV Saline.
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| 48 | 2021-01-21 | nausea |
Within the hour of having the injection , I was having a numbness sensation in my right eye and chee...
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Within the hour of having the injection , I was having a numbness sensation in my right eye and cheek area. Seen in the walk in clinic dx with Bells Palsy, seen in the ER, confirmed Bells palsy. Started prednisone. Symptoms within 3-4 days at 90%. Continued prednisone. Nausea, headache, aches on 1/4-1/6 felt better until 1/20- just had extreme back aches , 1/20 eye felt numb again, muscle movement remained the same. headache, body aches, pins and needles in 3 middle toes on the right side.
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| 48 | 2021-01-23 | nausea | Flu like aches and pains, low grade fever, nausea |
| 48 | 2021-01-23 | nausea |
chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking....
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chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking. anaphylaxis EKG monitoring, IVF, IM Epinephrine, IV Benadryl, IV Pepcid, Albuterol dual neb, CXR, Labs sent home after 6 1/2 hours of treatment and monitoring. Sent home with Epi pen
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| 48 | 2021-01-24 | nausea |
01.15.21 nauseous, headache with Fever with chills. 01.20.21 fever with chills still have chills an...
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01.15.21 nauseous, headache with Fever with chills. 01.20.21 fever with chills still have chills and body aches.
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| 48 | 2021-01-24 | diarrhea, abdominal pain upper | Headache, stomachache, diarrhea, chills, body aches |
| 48 | 2021-01-24 | nausea |
Increased blood pressure, light headed, nausea. Symptoms resolved in the ER and employee was able t...
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Increased blood pressure, light headed, nausea. Symptoms resolved in the ER and employee was able to return to full duty.
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| 48 | 2021-01-24 | nausea |
Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness a...
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Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness approx 1.25-1.5 hours after injection. around 12:10 pm or so. Removed excess clothing, put head between legs and turned on fan. Symptoms improved within 15 minutes. Headache later Saturday evening. Face hot and flushed and bad headache around 6pm Sunday evening. Face hot and flushed still Monday 1/25 in am but is getting a little better (I think) at the time of report.
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| 48 | 2021-01-24 | nausea | Vertigo for 3 hours intermittently, then nausea and mild dizziness from 7am- 5pm |
| 48 | 2021-01-24 | nausea |
approximately 5 minutes after vaccine administration, reported headache and nausea. Brief chest dis...
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approximately 5 minutes after vaccine administration, reported headache and nausea. Brief chest discomfort. No respiratory symptoms, REsolved after 30 minutes and discharged to home.
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| 48 | 2021-01-25 | vomiting, abdominal pain upper, nausea |
About 52 hours after my second shot I started to have upper abdominal pain, nausea and vomiting, whi...
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About 52 hours after my second shot I started to have upper abdominal pain, nausea and vomiting, which I also had roughly 5 days after my first covid vaccine shot. Once again, the pain and GI issues that took place were similar to when I had experienced pancreatitis previously. I contacted my PCP via our patient portal, and he said to report both instances to the CDC and follow previous protocol of a clear liquid diet and rest.
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| 48 | 2021-01-25 | nausea, abdominal discomfort, vomiting, abdominal pain |
About five days after my first shot I started to have upper abdominal pain, nausea and vomiting. The...
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About five days after my first shot I started to have upper abdominal pain, nausea and vomiting. The pain and GI issues that took place were similar to when I had experienced pancreatitis previously, so I contacted my PCP and GI/Liver doctor. The issues cleared up within about 4-5 days of being on a clear liquid diet and rest. I had blood work 01/14/21 and an ultrasound 01/19/21, both showing no signs of common bile duct blockage or pancreatic issues.
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| 48 | 2021-01-25 | nausea, diarrhea |
My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal B...
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My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal BP runs usually 115/78 to 120/78)paramedic check me at 15min twice at that time. my tong was felt numb; i went home and took some Benadryl and a Tylenol for my headache , rise my legs up for about 1hr drink 3 water bottles and less than 1/2hr, my BP drop to 113/75 i went to bed felt very tired , next day, very tired my BP low 106/70 muscles achy, got diarea and nausea per one day, since then my BP keeps low, I have no energy, I call my dr. yesterday, he advised that I should be good by today; my BP keeps been in the lows, my back hurts, i have no energy; I need to call back my dr. by Thursday or Friday to see how am i doing;. he referral to ENT to check on my smell and test as follow up because i have covid back in june2020 and I'm having a hard time with it.
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| 48 | 2021-01-25 | retching |
Same day of injection, recipient felt itching in back of throat, had to keep clearing throat; same d...
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Same day of injection, recipient felt itching in back of throat, had to keep clearing throat; same day recipient was seen in the ED with itchiness and dry heaves. Was treated with steroids, Benadryl, and Pepcid. On 1/17/2021 recipient returned to the ED with complaints of shortness of breath and itchy throat; she was unable to take oral steroids
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| 48 | 2021-01-25 | vomiting |
Shortness of Breath, vomiting x 1, body aches, headache, eyes were burning. Stayed in bed x 3 days...
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Shortness of Breath, vomiting x 1, body aches, headache, eyes were burning. Stayed in bed x 3 days Did not take any medications or seek medical attention
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| 48 | 2021-01-25 | nausea | Sore Injection Site, Neck Pain, Nausea and Weakness |
| 48 | 2021-01-25 | diarrhea, nausea, vomiting |
Sudden onset of nausea, vomiting, diarrhea, shortness of breath, uncontrolled shaking and vasovagal ...
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Sudden onset of nausea, vomiting, diarrhea, shortness of breath, uncontrolled shaking and vasovagal response with near syncope episode. Gave Diphenhydramine approximately 25 minutes after onset.
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| 48 | 2021-01-25 | abdominal pain |
Within 3 hours of the event, started having expected side effects of headache, bodyaches. That night...
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Within 3 hours of the event, started having expected side effects of headache, bodyaches. That night had difficulty sleeping and new onset neck pain as well. Finally took tylenol at 3AM. Woke up at 9:15 and walked from bedroom to kitchen at which time had severe orthostatic hypotension with near sycope that did not progress to full syncope due to lying down quickly. Continued with tachycardia for several days and mild shortness of breath for two days. That evening, had new onset RUQ abdominal pain for 2-3 hours that resolved.
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| 48 | 2021-01-25 | appendicitis, abdominal pain |
abd pain that began on 1/15/2021, 1/19/2021 admitted to hospital with Acute appendicitis with perfo...
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abd pain that began on 1/15/2021, 1/19/2021 admitted to hospital with Acute appendicitis with perforation
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| 48 | 2021-01-25 | nausea |
headache; tiredness/overwhelming feeling of tiredness; nausea; feeling "funny" in the head; a funny ...
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headache; tiredness/overwhelming feeling of tiredness; nausea; feeling "funny" in the head; a funny taste in the mouth; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 13Jan2021 07:50 at a single dose on Left Upper Arm Muscle for COVID-19 immunization. Medical history included thyroid disorder and antidepressant therapy. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder, duloxetine hydrochloride (CYMBALTA) as Antidepressant and multivitamins. The patient stated that she is calling about the COVID Vaccine, she just had the shot at 7:50AM this morning. After getting the shot she heard that she is not suppose to get the shot if she had tested positive for COVID before the vaccine. She wanted to know if this was true or a rumor. Back around Nov2020 she did test positive for COVID. It was the week before the holidays on Wednesday 18Nov2020 when she lost taste and smell, she then got tested on 19Nov2020 Thursday then got results Friday or Saturday morning, the weekend before the holidays that she was positive. The test was a nasal swab. The girls in the office said she was not suppose to get the shot if it had not been 3 months. When she had COVID shot they didn't tell her if she could take it or not. This morning she woke up everything was fine, she drove over to get vaccine, after they put the vaccine in, they made her wait 15- 30 minute, while waiting she was getting a headache, then the headache went away and she then felt funny in the head. She was a little nauseous then that went away. Then she had this overwhelming feeling of tiredness like she could go to bed. She felt bad a little bit. When she then drove back to work at the school she had this funny taste in the mouth. Her boss wanted to call and see if this is all normal. The date of first dose was 13Jan2021, all the symptoms she experienced occurred within half hour of receiving the vaccine. She thinks she is fine. At the moment she does not have the taste in mouth any longer and her headache left. She still feels funny in head as well as she just feels bad inside, she has the feeling of overwhelming tiredness, she just feels like something is coming on, like she knows she is getting sick. She has no Lot or Expiry to share, she vaccine CDC card is outside in the car and not physically with her. Her drive to get the vaccine was an hour away to a Hospital and all the medication was taken an hour before. She went to the hospital to have the vaccine administered. Then she drove to work at a school. She has had an antibody test, in which they draw blood, it was negative but that was even before she caught COVID, it was back in Aug2020 or Sep2020. She has had no issues with vaccines in the past. The outcome of the event headache, a funny taste in the mouth, and nausea was recovered on 13Jan2021, tiredness/overwhelming feeling of tiredness was unknown, feeling "funny" in the head was not recovered. The events were assessed as non-serious. Information about lot/batch number has been requested.
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| 48 | 2021-01-26 | diarrhea |
First inject lot # ej1685 in right arm. had itchy rash with open wounds all over right breast with...
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First inject lot # ej1685 in right arm. had itchy rash with open wounds all over right breast with burning pain. Was told is was shingles but wasn?t treated. Was told to get the second vaccine in the opposite arm to see if the same thing happens. Received 2nd injection in left arm and ended up with full blown symptoms of COVID. Uncontrollable shakes, cold, fever, severe body aches, cough, diarrhea and the rash still remains. As of today, I have an upper respiratory infection as well as the open rash, which the PCP listed has taken control of and deemed the cause side effects of the second injection.
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| 48 | 2021-01-26 | nausea |
Sudden headache, nausea, then itching all over, rash on chest then stomach. Swollen and redness lik...
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Sudden headache, nausea, then itching all over, rash on chest then stomach. Swollen and redness like golf ball size at and around site the next morning. Still itching the next morning after taking Benadryl and Tylenol every 4 hours as suggested by physician.
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| 48 | 2021-01-26 | abdominal pain |
lower abdominal cramping, especially right lower quadrant and right lower back pain. Felt like mens...
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lower abdominal cramping, especially right lower quadrant and right lower back pain. Felt like menstrual cramps but was not accompanied by a period (I have had an endometrial ablation), nor was it the time for me to have a period. I have never had this pain so persistent and severe. Completely relieved by Tylenol 1000mg every 6 hours, which was needed around the clock to keep the pain away so I could function. On day 5 I was seen by the NP who ordered a transvaginal ultrasound. She did not feel my pain was GYN-related. the pain stopped on Saturday Jan 2, 2021. GYN NP referred me to GI Dr., who I saw on 1-13-2021, he did not feel the pain was GI related, no testing done at that time (I was no longer having the pain). I am scheduled for colonoscopy on 2-3-2021, only because I need a routine screening because of my age, it was not ordered because of the pain I felt in December.
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| 48 | 2021-01-28 | vomiting, nausea, abdominal discomfort |
4:30 I had a bowel movement; colon felt funny on descending side; Had dinner around 6:30 pm and abou...
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4:30 I had a bowel movement; colon felt funny on descending side; Had dinner around 6:30 pm and about 9:00 pm, I took vitamins and I started feeling queasy and nauseous. Laid there about an hour trying to keep food down. Decided I was still hungry and Had a hard boiled egg. But got nauseous again. Mouth started to water and I vomited everything that was in my stomach - intense vomiting. My intestines on left side after that was on fire- pain was so intense that my husband to ER (Emergency Room). They did a CAT scan - Colitis going on in there. They gave me morphine. The pain (on left side of intestine) continues for about another week but not as intensely as it was at first. I saw my GI Dr yesterday and colonoscopy and and EDG in March. I have pain meds that I was given and I have about four left and I am using them sparingly so I won't feel that pain anymore. So it is still there.
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| 48 | 2021-01-28 | nausea |
Hours 18-30 after the 2nd dose of covid vaccine, I had bad headache (sensitivity to light), body ach...
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Hours 18-30 after the 2nd dose of covid vaccine, I had bad headache (sensitivity to light), body aches, nausea, and very tired. Slept all day, got up for dinner, then went back to bed. Woke up the next day and felt 100% good. I. Other words, had the 2nd dose on Monday morning, Tuesday felt awful, Wednesday felt perfectly fine.
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| 48 | 2021-01-28 | vomiting |
Post injection of 2nd COVID-19 Pfizer dose, pt suddenly vomitted (15 min post injection), had uticar...
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Post injection of 2nd COVID-19 Pfizer dose, pt suddenly vomitted (15 min post injection), had uticaria of arms and legs (30 min post injection), and asthma like symptoms such as wheezing, SOB (35min post injection). Diphenhydramine 50mg PO given and pt transferred to ED for observation. In ED, pt received albuterol 0.083% neb, diphenhydramine 25mg IV, famotidine 40mg IV, hydroxyzine 25mg PO, Duoneb 3mL, and Solumedrol 125mg IV. All reactions resolved prior to ED discharge several hours later.
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| 48 | 2021-01-28 | abdominal pain upper | Rapid heart rate, heart palpitations, stomach pain?started 12 hours after vaccine. |
| 48 | 2021-01-28 | vomiting, nausea | nausea, vomiting, malaise |
| 48 | 2021-01-28 | decreased appetite, nausea |
severe myalgia; headache; dizziness; nausea; anorexia; chills; fatigue; This is a spontaneous report...
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severe myalgia; headache; dizziness; nausea; anorexia; chills; fatigue; This is a spontaneous report from a contactable physician (patient herself). A 48-year-old female patient (non-pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration on 11Jan2021 11:15 in left arm at single dose for covid-19 immunization. Medical history included migraine headaches, depression, antiphospholipid antibody syndrome. Known allergies was no. Other medications in two weeks included fluoxetine, propranolol, spironolactone. The patient previously the first dose of bnt162b2 (lot# EK5730), via an unspecified route of administration on 23Dec2020 15:00 in left arm at single dose for covid-19 immunization. No other vaccine in four weeks were taken. Facility type vaccine was hospital. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The patient experienced severe myalgia, headache, dizziness, nausea, anorexia, chills and fatigue on 12Jan2021. Treatment was acetaminophen. Outcome of all events were recovering.
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| 48 | 2021-01-29 | nausea |
Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and...
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Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and tingling in vaccine arm Went to ER for monitoring Ten minutes after started the worst headache of my life and I get migraines Have had pulse racing and slight chest pains all afternoon Went home after 4 hours observing Got a steroid through IV Fever has started after 12 hours
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| 48 | 2021-01-29 | nausea, abdominal pain upper |
Malaise and severe joint pain, nausea, frequency in bowels, stomach pain, dizziness, headache that s...
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Malaise and severe joint pain, nausea, frequency in bowels, stomach pain, dizziness, headache that started about 12 hours post injection in the night. Arm pain radiating into axilla and down arm from injection site. A bit disoriented upon waking, pushed fluids and OTC meds with some relief of pain but GI symptoms persisted.
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| 48 | 2021-01-29 | nausea |
with dose 1given on 1/7/21 - within 5 mins -flushing, headache, chills, back pain., high blood press...
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with dose 1given on 1/7/21 - within 5 mins -flushing, headache, chills, back pain., high blood pressure in 150's, fatigue. Headache and backache lasted for 4 days. Fatigue for a week. I was monitored for 2 hours after injection. With dose 2 on 1/29/21- immediate - nausea, headache, lightheadedness, chest discomfort, very sleepy like I just wanna go to sleep right away. I was monitored for 2 hours until Chest discomfort subsided. nausea took more than 3.5 hours. headache is still on today the next day. Midnight -I had severe severe joint pains like my bones were ripping apart. very sleepy. i slept 12 hours straight. still have headache.
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| 48 | 2021-01-31 | nausea |
Fever chills, headache, nausea , vomiting , a large amount of pain from vaccination. The first one n...
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Fever chills, headache, nausea , vomiting , a large amount of pain from vaccination. The first one no pain . The second one really hurt maybe due to the person giving it . I had a fever low grade till noon 1/31/21. The scariest was pain and swelling in my lower armpit on my left arm where vaccinated. I found a study that it can happen but I freaked out . 48 after I experienced the lymphnodes swelling the pain went away but still swollen . I think this should be listed as people with a cancer history will freak out if they think their cancer is back . Lymphoma or breast . I aldd also read that vaccinated women need to alert their radiologists before a mammogram as the swollen lymphnodes could mimic Breast cancer and lymphnodes involvement, which would scare women to death . Physicians should be made aware and the public should be iNformed of the above to reduce panic and unnecessary testing .
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| 48 | 2021-02-01 | nausea |
nauseous; mild to moderate arm pain; injection site pain; Pain was from wrist to shoulder; moderate ...
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nauseous; mild to moderate arm pain; injection site pain; Pain was from wrist to shoulder; moderate vasomotor symptoms; body aches; This is a spontaneous report from contactable nurse (patient herself). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 10:00 in right deltoid at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included estrogens conjugated, medroxyprogesterone acetate (PREMPRO). On 19Jan2021, patient experienced mild to moderate arm pain in arm that had shot, more than just injection site pain. Pain was from wrist to shoulder. 2-3 hours later moderate vasomotor symptoms followed with body aches. She took celecoxib (CELEBREX)and paracetamol (TYLENOL), body aches got better. 7 hours post injection, she felt nauseous and took ondansetron (ZOFRAN). Outcome of events were unknown. Information on the lot/batch number has been requested.
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| 48 | 2021-02-01 | diarrhea, vomiting |
severe body aches; chills; low grade fever; diarrhea; vomiting; This is a spontaneous report from a ...
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severe body aches; chills; low grade fever; diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 15Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included hypertension, endometrial cancer and radiation therapy from an unknown date and unknown if ongoing. Concomitant medication included lisinopril. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Jan2021 10:00 AM, the patient stated, "the second day I began having severe body aches, chills, low grade fever, diarrhea, and vomiting. I received radiation therapy three days prior to getting Pfizer vaccine". The outcome of the events was recovering. No treatment for the events was given to the patient. Information on the batch/lot number has been requested.
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| 48 | 2021-02-03 | diarrhea, nausea |
Headache ,Fever ,Nausea, joint pain, diarrhea, loss of taste and smell tested positive for Covid 19...
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Headache ,Fever ,Nausea, joint pain, diarrhea, loss of taste and smell tested positive for Covid 19 on 12/31/2020
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| 48 | 2021-02-03 | nausea, diarrhea | Increasing palpitations over the past two days along with some diarrhea and nausea |
| 48 | 2021-02-03 | difficulty swallowing |
Rash chest and face. Face and throat swelling. Difficulty swallowing. Taken to ER and given steroid...
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Rash chest and face. Face and throat swelling. Difficulty swallowing. Taken to ER and given steroid, benadryl, and pepcid. Systemic affects x3 days. Medications given for a total of 5 days.
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| 48 | 2021-02-03 | nausea |
Site pain; Headache; Nauseous; Cough; Felt congested; No taste or smell; No taste or smell; This is ...
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Site pain; Headache; Nauseous; Cough; Felt congested; No taste or smell; No taste or smell; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EF9231; Expiration date was not reported) on 11Jan2021 (09:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included breast cancer and hypertension. The patient's concomitant medications were not reported. On 18Jan2021, the patient had site pain; headache; and was nauseous. On 13Jan2021, the patient had cough. In Jan2021, after the vaccination, the patient had felt congested. In Jan2021, almost two weeks after the vaccination, the patient had no taste or smell. The reported events had resulted in the emergency room/department or urgent care. The outcome of the events, 'site pain', 'headache', 'nauseous', 'cough', 'felt congested' and 'had no taste or smell', was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. On 20Jan2021, the patient had a nasal swab COVID-19 test, and was negative.
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| 48 | 2021-02-03 | nausea, abdominal discomfort |
headaches; upset stomach; nausea; body aches; Administration date: dose 1: 16Dec2020, Dose 2: 18Jan2...
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headaches; upset stomach; nausea; body aches; Administration date: dose 1: 16Dec2020, Dose 2: 18Jan2021; Administration date: dose 1: 16Dec2020, Dose 2: 18Jan2021; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 at 14:45, in left arm, at single dose, for Covid-19 immunization. Co-suspect drug included acetaminophen (unknown manufacturer) as preventive medication. The patient received the first dose of BNT162B2 vaccine on 16Jan2021 at 17:15, in left arm with preventive acetaminophen and she felt no effects. The patient had not been tested for COVID19 nor before neither since the vaccination. Concomitant medication taken within 2 weeks of vaccination included high pressure medication. On 19Jan2021 at 08:15 the patient experienced headaches, upset stomach, nausea and body aches. She forgot to take that morning her high pressure medication, she took it, but symptoms continued. She expressed that symptoms were mild but noticeable. No treatment was received. The action taken with acetaminophen was unknown. The events resolved on an unspecified date in Jan2021. Information on the lot/batch number has been requested.
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| 48 | 2021-02-04 | vomiting, nausea |
About 8 hours after receiving vaccine, the skin around my face, arms and chest became red and had wh...
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About 8 hours after receiving vaccine, the skin around my face, arms and chest became red and had whelps and burned like it was on fire. I had a horrible headache. Later around midnight I started vomiting and had uncontrollable chills but skin was still burning never had a fever. The whelps and burning went away completely after about 12 hours and taking 2 (25 mg) Benadryl. The nausea , headache and chills lasted several days.
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| 48 | 2021-02-04 | nausea |
Headache; Nauseous; This is a spontaneous report from a contactable consumer (patient's daughter). ...
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Headache; Nauseous; This is a spontaneous report from a contactable consumer (patient's daughter). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899 with Expiration Date 31Mar2021), via intramuscular, on 05Jan2021 at 0.3 mL single dose on the right arm for COVID-19 immunisation. Relevant medical history included ongoing thyroid problems (did not remember but she thought it was about 4 years ago that this was diagnosed), and menopause from Aug2020. No relevant concomitant medications were provided. On 06Jan2021, the patient developed headache. She had a really bad headache for about 9 days she ended up going to urgent care because of that, she was nauseous and went to the urgent care and they said they were side effects from the vaccine, she said the headache was extreme. She is wondering if it is okay to even take the second dose after having side effects. The patient had recovered from 'nauseous' on 10Jan2021 and from headache on 14Jan2021.
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| 48 | 2021-02-04 | nausea | Nausea, headache, fever, fatigue. |
| 48 | 2021-02-04 | abdominal pain, abdominal discomfort, diarrhea |
Started with headache, then body aches and upset stomach, abdominal cramping, and diarrhea. Started ...
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Started with headache, then body aches and upset stomach, abdominal cramping, and diarrhea. Started approximately 2 hours after injection lasting through current time (27 hours after injection)
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| 48 | 2021-02-04 | nausea |
it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left ton...
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it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left tongue felt numb and fat as though I got injected at the dentist; Then medicine taste in my mouth and some slurring; Then medicine taste in my mouth and some slurring; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received first dose of BNT162B2 (Lot number and expiry date not available), via an unspecified route of administration on 21Jan2021 10:45 at single dose in the left arm for COVID-19 immunization. Medical history included Hypo thyroid (medication not needed at this time). The patient had no known allergies. Concomitant medication included cefixime (FLEXERIL) and ibuprofen (IBU). On 21Jan2021 11:00, after 15 minutes of getting the vaccine, the patient felt nauseated. Then it continued to get worse from there left side of face numb, mental fog, left tongue felt numb and fat as though she got injected at the dentist. Then medicine taste in her mouth and some slurring. Stated that her boss which is doctor side it looks and sounds like she has Bell palsy. She was prescribed Methylprednisolone and she feel somewhat better. Still waiting to feel completely myself. It's been now about 8 hours since her vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all the events which included methylprednisolone. The outcome of the events was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 to the onset of reported events Bell palsy and mental fog occurred 15 minutes after getting the vaccine cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-02-05 | vomiting, nausea |
Adverse Event: Severe headache (HA), chills, nausea, vomiting, lightheadedness. Slight headache bega...
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Adverse Event: Severe headache (HA), chills, nausea, vomiting, lightheadedness. Slight headache began around 7pm, HA worsened in severity within an hour, chills started around 7:30pm. I then took my temperature at home (96.5F). After getting my temperature, I took 2 Tylenol at 7:45pm, dry heaved at 8pm. My HA was refractory to Tylenol and continued to worsen. I went to the Emergency Department at Hospital where I reported pain as a 10/10. I then vomited in the waiting room. I was brought back to a room, gave a urine sample and gave blood for testing. I was then given IV fluids and later given a CT scan. Test results are below in Item 19. Treatment: IV fluids (2 bags), rest, oral hydration and food. Outcome: Within minutes of vomiting, pain went down to 4/10. With in the hour, I had fully recovered.
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| 48 | 2021-02-05 | diarrhea, nausea |
I had a slightly elevated temp after the shot on 1-23. At 6:45 am on the 24th it was 99.9 . All of a...
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I had a slightly elevated temp after the shot on 1-23. At 6:45 am on the 24th it was 99.9 . All of a sudden I felt a heat throughout my body and felt on fire while also feeling an urge of diarrhea and nausea. I tried to go to the bathroom, but kept passing out. I could not see, but was conscious. It took me 15 minutes to crawl to the bathroom. I did not vomit and passed watery stool x 2. The episode passed after about 40 minutes. I continued to have a slight elevated temp all day after that episode, but only 99.6 and below. There were no more issues after that brief, horrible reaction. I am 101 lbs.
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| 48 | 2021-02-07 | diarrhea |
Got vaccine on 2/5/2021 started with diarrhea that evening and the next day, Saturday became fatigue...
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Got vaccine on 2/5/2021 started with diarrhea that evening and the next day, Saturday became fatigue continues intermittently, Sunday 2/7/2021 noticed swelling to the left axilla with enlarged lymph node continues with it today 2/8/2021
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| 48 | 2021-02-07 | nausea | Pain in arm headache nausea fever body aches joint aches sensitive to light |
| 48 | 2021-02-09 | abdominal pain upper |
Developed mid to right sided upper abdominal pain that radiated into back on 12/31/20, admitted to h...
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Developed mid to right sided upper abdominal pain that radiated into back on 12/31/20, admitted to hospital on 1/2/21 for pancreatitis along with 2 other admissions (1/16/21 & 1/30/21) for same abdominal pain radiating into back.
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| 48 | 2021-02-09 | nausea |
migraines; blood glucose dropped below 80; severe shakes; nausea; This is a spontaneous report from ...
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migraines; blood glucose dropped below 80; severe shakes; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 14:30 at single dose at left arm for covid-19 immunization. Medical history included fibromyalgia, chronic migraines, degeneraive disc disease, spinal spinosis, celiac, arthritis, and type 2 diabetic, known allergies. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks included prescribed medications. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Patient was a type 2 diabetic and the next day after the injection, on 05Jan2021 08:00 patient blood glucose dropped below 80 and patient usually run 128 and above. It was hard getting BG level up over 100 for over two weeks and patient had severe shakes, nausea, and migraines as an adverse effect from very low BG levels. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events was not recovered. Patient lowered insulin units as treatment.
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| 48 | 2021-02-14 | nausea, abdominal pain upper, vomiting |
upper abdominal pain; Nausea; Vomiting; This is a spontaneous report from an Other Health Profession...
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upper abdominal pain; Nausea; Vomiting; This is a spontaneous report from an Other Health Professional. A 48-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration in the right arm at 48-years-old on 31Dec2020 at 15:15 at a single dose for COVID-19 immunization; administered at a hospital. The patient did not receive any other vaccine within four weeks prior of receiving bnt162b2. Medical history included non-alcoholic steatohepatitis (NASH liver disease) from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, endometriosis from an unknown date and unknown if ongoing, penicillin allergy from an unknown date and unknown if ongoing, gluten sensitivity from an unknown date and unknown if ongoing, sulfonamide allergy from an unknown date and unknown if ongoing , hibiclens soap allergy from an unknown date and unknown if ongoing, pancreatitis from an unknown date and unknown if ongoing. Concomitant medications included colestipol (MANUFACTURER UNKNOWN), nebivolol hydrochloride (BYSTOLIC), levothyroxine sodium (UNITHROID), liothyronine (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unspecified date to an unspecified date. The patient previously took pregabalin (LYRICA), clindamycin (MANUFACTURER UNKNOWN), buprenorphine (BUTRANS) and experienced allergies from an unknown date and unknown if ongoing. On 05Jan2021 at 19:00, the patient experienced: upper abdominal pain (non-serious), nausea (non-serious), and vomiting (non-serious); with no treatment received. Adverse event: About five days after the first dose, the patient started to have upper abdominal pain, nausea and vomiting. The pain and gastrointestinal (GI) issues that took place were similar to when the patient had experienced pancreatitis. The patient then contacted her primary care physician (PCP) and GI/Liver doctor. The issues cleared up within about 4-5 days of being on a clear liquid diet and rest. The patient had an ultrasound and blood work one week later, both showing no signs of common bile duct blockage or pancreatic issues. The patient underwent lab tests and procedures which included blood work and ultrasound: no signs of common bile duct blockage or pancreatic issues on an unknown date. The clinical outcome of the events was recovered on an unspecified date. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.
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| 48 | 2021-02-17 | vomiting |
pass out; vomiting; Severe muscle pains; Severe headache; This is a spontaneous report from a contac...
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pass out; vomiting; Severe muscle pains; Severe headache; This is a spontaneous report from a contactable Other HCP (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 at 10:00 at single dose in left arm for COVID-19 immunisation at the age of 48-year-old. Lot number was EL3248. Medical history included asthma, migraine headaches, thyroiditis. Concomitant medications included levothyroxine, fluoxetine, bupripion, clonazepam. The patient was not pregnant. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Jan2021 at 15:00 at single dose in right arm for COVID-19 immunisation at the age of 48-year-old. On 02Feb2021 at 23:00, the patient experienced severe vomiting which kept the patient up most of the night, she had to stay by toilet; the patient was feeling like she was going to pass out with any movement, the patient experienced severe muscle pains that felt almost like bones were breaking inside; the patient experienced severe headache; the patient almost took her-self to the emergency room in the middle of the night, but she did not want to expose her compromised immune system to others. The patient was not treated for the events. The patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the LOC and other reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics including chemistry panel, Head CT/MRI and EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-02-21 | nausea, vomiting, diarrhea |
patient was not vaccinated at hospital. Caregiver reports that patient was vaccinated with second d...
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patient was not vaccinated at hospital. Caregiver reports that patient was vaccinated with second dose on Monday 2/15/21. Tuesday patient experienced n/v/d. Went to an ED on Wednesday and was cleared and sent home. Thursday reported shortness of breath to her caregiver and then collapsed. Patient was brought to as PEA arrest and ultimately died.
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| 48 | 2021-02-22 | nausea |
I received the Vaccine on 2/18 .At 22:00 I had chills and low grade Fever. Middle of the night I fe...
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I received the Vaccine on 2/18 .At 22:00 I had chills and low grade Fever. Middle of the night I felt fatigue and body aches, dull Headache. In the morning I was nauseus. The symptoms lasted for 24 hours.
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| 48 | 2021-02-22 | nausea |
Pt received dose 2 of Pfizer Covid vaccine at 12:00pm and soon after reported symptoms of nausea, SO...
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Pt received dose 2 of Pfizer Covid vaccine at 12:00pm and soon after reported symptoms of nausea, SOB, wheezing, sweating, and numbness on left side from face to arm. Pt was given oxygen and 0.3mg of epinephrine was given intramuscularly at 12:05pm, followed by 25mg of diphenhydramine intramuscularly at 12:08, both administered by RN on site. Paramedics arrived at the scene at 12:05pm and took over monitoring of pt; pt was taken to ambulance at 12:10pm
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| 48 | 2021-02-22 | nausea |
Significant Left under arm swelling (area swollen approximately size of baseball in half) Significa...
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Significant Left under arm swelling (area swollen approximately size of baseball in half) Significant pain under left arm Redness along outside of left breast Pain in Left breast Pain Left shoulder to Left elbow Nausea and hot flashes - Mild
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| 48 | 2021-02-23 | nausea | Headache and dizziness Diarrhea Nauseated Pain in arm and numbness from shoulder to elbow Fatigue |
| 48 | 2021-02-23 | diarrhea, vomiting, nausea | Nausea, vomiting, diarrhea, headache, and chills. |
| 48 | 2021-02-23 | nausea |
chills; headache; sore throat; nausea; Loss of smell; This is a spontaneous report from a contactabl...
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chills; headache; sore throat; nausea; Loss of smell; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscularly on the right arm, on 05Jan2021 10:00, at single dose, for covid-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Concomitant medications included omeprazole; metoprolol; methocarbamol; vitamin d3; pregabalin; and levothyroxine. The patient did not have Covid prior vaccination. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. With the first shot the patient experienced chills, headache, sore throat, nausea and, loss of smell - all on 08Jan2021. These adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for these adverse events. At the time of the report, the patient was recovering from the events. The patient had a nasal swab for Covid on 11Jan2021 with results of negative.
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| 48 | 2021-02-24 | abdominal pain upper, diarrhea, abdominal discomfort |
Onset Sunday February 21, 2021: headache, stomach cramping, diarrhea, fatigue, muscle aches Monday F...
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Onset Sunday February 21, 2021: headache, stomach cramping, diarrhea, fatigue, muscle aches Monday Feb 22: symptoms not as severe Tuesday Feb 23: headache and stomach cramps remain, with some gastrointestinal distress Weds Feb 24: symptoms diminished significantly Thursday Feb 24: symptoms dissipated completely
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| 48 | 2021-02-25 | nausea | Chills, fever, full body sweat, nausea 1 day |
| 48 | 2021-02-25 | diarrhea |
Fever; cough; diarrhea; swelling; burning; This is a spontaneous report from a contactable consumer....
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Fever; cough; diarrhea; swelling; burning; This is a spontaneous report from a contactable consumer. A 48-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176) via an unspecified route of administration in right arm on 22Jan2021 12:00 at single dose for COVID-19 immunisation. The patient received the vaccine in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient received unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever, cough, diarrhea, swelling, burning on 22Jan2021 16:00. The patient didn't receive any treatment for events. The outcome of events was recovering.
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| 48 | 2021-02-25 | abdominal pain |
Stabbing abdominal pain for 18 hours, brain fog, fatigue, headache, sinus congestion, mild pain at i...
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Stabbing abdominal pain for 18 hours, brain fog, fatigue, headache, sinus congestion, mild pain at injection site. Symptoms started 2.5 hours after injection and lasted 30 hours.
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| 48 | 2021-02-26 | abdominal discomfort, diarrhea, nausea | Fever, joint pain, headaches, fatigue, stomach issues (nausea, diarrhea), body aches |
| 48 | 2021-02-27 | difficulty swallowing | swollen tongue, difficulty swallowing and breathing, itching, rash, headache, ache, fatigue |
| 48 | 2021-02-28 | nausea |
Headache, chills, nausea, arm pain severe, tired. stared 24 hrs after Vaccination, Day after just pa...
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Headache, chills, nausea, arm pain severe, tired. stared 24 hrs after Vaccination, Day after just pain in Rt Arm.
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| 48 | 2021-02-28 | abdominal pain upper, abdominal pain |
I have been Post menopausal for over 3 years now. And I woke up around midnight with the worst abdom...
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I have been Post menopausal for over 3 years now. And I woke up around midnight with the worst abdominal pains ever. Then I stared spotting and I haven't stopped. My stomach cramps are not as bad but I still have them along with the spotting.
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| 48 | 2021-02-28 | nausea |
Pt. received second dose of Pfizer vaccine on 2/24/2021, on 2/25/2021 at 12:30 pm she stated she bec...
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Pt. received second dose of Pfizer vaccine on 2/24/2021, on 2/25/2021 at 12:30 pm she stated she became flushed and was nausea's. Went to put her head down on desk, head hit desk and she fell to her knees. Pt. unsure if she lost consciousness. She described going form extremely hot to cold. Ambulance called and taken to ER
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| 48 | 2021-02-28 | nausea |
The vaccine was given on Tuesday, Feb 23, 2021, and on Wednesday 24, 2021 I had an awful headache, f...
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The vaccine was given on Tuesday, Feb 23, 2021, and on Wednesday 24, 2021 I had an awful headache, feelings of nausea, extreme tiredness, and arm pain. Wednesday 25,2021 most symptoms did not reoccur. Except now there is pain on my right side, back of the neck, shooting down the middle of the right shoulder blade. I took Midol for Wednesday's symptoms and went to bed before 8 pm. Woke up feeling better except for shoulder pain. Thursday I felt like I had a stiff neck so I took Ibuprophen and hubby massaged the area. Massage helped for about 30 min. The pain persisted on Friday still tried massage and Ibuprophen still very painful and now hard to be comfortable sitting and sleeping. Saturday morning I tried a warm shower and heat pad throughout the day pain still persisted. No ibuprofen and still massaged area. Sunday morning I soaked in the tub with Epsom salts and pain still continued throughout the day. Monday called dr. and she encouraged me to fill out a report and take vitamin C seems to think lymph nodes are clogged.
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| 48 | 2021-03-03 | retching |
Approx 3 minutes after receiving the vaccine she became very anxious. She started dry heaving into ...
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Approx 3 minutes after receiving the vaccine she became very anxious. She started dry heaving into the trash can. She also has hypoglycemia and her BS was 100. She was able to calm herself down without medications. Her doctor told her next time to eat more before she goes.
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| 48 | 2021-03-04 | difficulty swallowing |
About 10 mins post vaccine my throat started to feel tight and almost numb.....then I was having dif...
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About 10 mins post vaccine my throat started to feel tight and almost numb.....then I was having difficulties swallowing, as if there was a lump in my throat......a few mins later my inner ears felt like they were burning and I felt pressure. I asked staff if symptoms were a side effect of vaccine at 15 minute mark from waiting period. They had me sit back down for another 15 mins and paramedic come see me. I told him I felt fine other than my throat feeling like it was as getting tighter and the difficulty swallowing. He offered to take my stats and I asked him to wait to see if symptoms would dissipate. After approx 49 mins of waiting from initial shot dose, my heart felt like it was racing and my throat felt tighter and I was now having a much harder time swallowing and I felt lightheaded. They took me back and hooked me up to get my vitals. About 7 mins later they brought an EPI Pen and I administered the shot in my leg. After approx 10mins +/- I began to feel my throat loosening a little. Then over the next 10 mins or so I felt almost normal with little trouble swallowing. They told me that I needed to go to the ER for further Eval. I arrived at ER approx 15 mins later and they gave me 2 Benadryl and 2 steroid pills and monitored me for the next 4 hrs - I was released shortly after - and again no other pain or side effects after EPI Pen and meds they administered. Sent home with EPI Pen and Steroids and instructions on what to watch for.
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| 48 | 2021-03-04 | nausea, diarrhea | DIZZINESS, NAUSEA, CRAMPS, DIARRHEA, HEADACHE, FATIGUE. |
| 48 | 2021-03-04 | difficulty swallowing |
It started out as an itchy area under the band aid. I took the band aid off and the itching got wors...
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It started out as an itchy area under the band aid. I took the band aid off and the itching got worse and went down my arm. A minute left after waiting 15 minutes I let the nurse know the reaction I was having ( bad itching), she looked at it and was red. She said it could be a site reaction and gave me an ice pack. Another nurse came to check on, and I told her I was really thirsty. By the time she got back my lips were feeling very heavy, lips itching and difficult to swallow, then my whole chest was covered in a red rash. With in a couple minutes there was a paramedic there and was more difficult to swallow, they tried to give me Benadryl thru an IV and blew my vain. So he asked me for a IM shot of Benadryl, I said yes and took me to the ER. By the time got there the Benadryl wore off and my lips got itchy and they took me right to the room and Dr gave me IV Solumedrol and Benadryl. They watched me for two hour sin the ER , they released me with 3 days of prednisone, Epipen, Benadryl. I went to the pharmacy (15 minute drive from ER) and both my eyes starting swelling, so I took 50mg of Benadryl capsule and the next day I started the prednisone, I had to take Benadryl every 3 hours for the next couple days because my eyes would start swelling.
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| 48 | 2021-03-10 | vomiting |
COVID-19 pneumonia; Fever (body temperature at 102.7 Fahrenheit); Threw up; littles scratchy throat;...
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COVID-19 pneumonia; Fever (body temperature at 102.7 Fahrenheit); Threw up; littles scratchy throat; Cough; Sore throat; Dizzy spells; Runny nose /nose was a faucet; Little sore arm; Fatigue; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 48-year-old female patient (weight: 148.32 kg, height: 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL9262) intramuscularly, in the left arm, at single dose, on 28Jan2021, at 13:30, for COVID-19 immunisation. Relevant medical history included light Crohn's disease from an unspecified date. Concomitant medications included oral fexofenadine hydrochloride (ALLEGRA) 60 mg, twice daily (60 mg, 1 tablet every 12 hours), from 02Feb2021 to 05Feb2021, for nasal congestion; oral paracetamol (TYLENOL, capsule) 500 mg capsule (she took 2 as needed), from 02Feb2021 and ongoing, for fever and headache; salbutamol (ALBUTEROL) 90 mcg, 2 puffs every 4-6 hours as needed, from 06Feb2021 and ongoing, for breathing problems and oral benzonatate 100 mg, thrice daily (100 mg capsules, 1 by mouth three times daily as needed) from 06Feb2021 and ongoing, for cough. On an unspecified date, in Feb2021, the patient developed little sore arm and fatigue. On 01Feb2021, the patient experienced runny nose, nose was a faucet. On 02Feb2021, she had little scratchy throat, cough, sore throat and dizzy spells. On 04Feb2021, she threw up and on 05Feb2021, the patient experienced fever (she had temperature at 102.7 Fahrenheit) and then was hospitalized. Post the vaccination, the patient has been tested for COVID-19 on 05Feb2021 and resulted positive and pneumonia requiring hospitalization. She was admitted on the 05Feb2021 discharged on the 09Feb2021. Chest x-ray and CT chest performed on 05Feb2021 showed pneumonia. Body temperature on 05Feb2021, at night, was 102.8 Fahrenheit. Oxygen saturation (pulse ox) showed the following value: 80s, 84 and 93 on an unspecified date, in Feb2021. Emergency Room Visit and Physician Office Visit required for runny nose, throat irritation, cough, sore throat and pneumonia. Treatment was received for COVID-19 pneumonia, fever, runny nose, throat irritation, cough and sore throat. She was supposed to get the second vaccine on the 18Feb2021. The patient recovered from fever on 07Feb2021, did not recover from dizzy spells, while clinical outcome of the other events was unknown at time of this report.
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| 48 | 2021-03-10 | abdominal pain |
Chills; Pain in hips; Cramping in abdomen; Pain in left ear; This is a spontaneous report from a con...
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Chills; Pain in hips; Cramping in abdomen; Pain in left ear; This is a spontaneous report from a contactable consumer(patient) reported that. A 48-years-old female patient started to receive bnt162b2 (BNT162B2Formualation:Solution for injection ) ,via an unspecified route of administration from 28Jan2021 14:45 to 28Jan2021 14:45 at SINGLE DOSE for an unspecified indication .Medical history included sialadenosis from an unknown date and unknown if ongoing , cervix carcinoma from an unknown date and unknown if ongoing , covid-19 from an unknown date and unknown if ongoing If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The patient experienced chills on 28Jan2021 19:00 , pain in hips on 28Jan2021 19:00 cramping in abdomen on 28Jan2021 19:00 pain in left ear on 28Jan2021 19:00 and The patient underwent lab tests and procedures which included body temperature: 97.3 on Temperature under the tongue was 97.3 and outcome of the events was unknown Information on the Lot/Batch number has been requested.
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| 48 | 2021-03-14 | vomiting, nausea |
nausea; vomiting; headache; feeling feverish (no fever); Feeling beat up; dizziness; fatigue; This i...
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nausea; vomiting; headache; feeling feverish (no fever); Feeling beat up; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm, on 05Feb2021 at 11:45 (at the age of 48-years-old) at a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included fingolimod hydrochloride (GILENYA), baclofen (MANUFACTURER UNKNOWN), mirabegron (MYRBETRIQ), bupropion hydrochloride (WELLBUTRIN), and hydroxyzine hydrochloride (HYDROXIN). The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergies and ibuprofen (MANUFACTURER UNKNOWN) and experienced allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced dizziness and fatigue on 05Feb2021 and nausea, vomiting, headache, feeling feverish (no fever), and feeling beat up on 06Feb2021 at 13:30. The events were reported as non-serious. The clinical course was reported as follows: Within one to two hours (as reported), on and off, the patient felt dizziness and fatigue. After 26 hours (as reported), the patient felt nausea, vomiting, headache, fatigue, feeling feverish (no fever) and feeling beat up. The feeling beat up lasted 12-14 hours and the headache lasted 2 days. The patient did not receive any treatment for the events. The clinical outcome of dizziness, fatigue, nausea, vomiting, and feeling feverish (no fever) was recovered on an unspecified date, feeling beat up was recovered on 07Feb2021, and headache was recovered on 08Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 48 | 2021-03-17 | diarrhea, nausea, decreased appetite |
loss of appetite; spontaneous bleeding under skin by right eye; severe pain under arm in armpit with...
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loss of appetite; spontaneous bleeding under skin by right eye; severe pain under arm in armpit with swelling; severe pain under arm in armpit with swelling; hot feeling on skin; extreme fatigue; had some itchy skin and redness an hour after shot, especially on both arms; had some itchy skin and redness an hour after shot, especially on both arms; Extremely nausea/Often nauseous; insomnia; mild diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809; expiration date not provided), via an unspecified route of administration (anatomical location: arm right) on 09Feb2021 18:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included asthma and known allergies to sulfa drug both from unknown dates and unknown if ongoing. The patient has no COVID prior vaccination. Patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262; expiration date not provided) on 19Dec2020 02:30 pm (vaccination location: left arm) and experienced dizziness, extreme itchy skin, headache, and fatigue reported as 'After 1st shot had dizziness and extreme itchy skin 1 hour after shot for approx 2 hours before it ended, then headache and fatigue for 1-2 days. However, after 48 hours all effects from the 1st shot were gone'. The patient experienced spontaneous bleeding under skin by right eye on 14Feb2021. Patient's clinical course is as follows: After 2nd shot, patient had some itchy skin and redness an hour after shot, especially on both arms that lasted a couple hours (started at 7PM and stopped at 9PM). Patient also had extreme fatigue everyday since 11Feb2021, as well as insomnia especially during the first 48 hours. Also had total loss of appetite the past 8 days (17Feb2021), extremely nauseous and mild diarrhea everyday since immediately after 2nd shot until now (8 days later) with no improvement. Often nauseous until close to the point of vomiting. 2 days after 2nd shot started having severe pain under arm in armpit area with swelling and hot feeling on skin. Developed some spontaneous bleeding under skin by right eye about 5 days (14Feb2021) after shot which has now gone away. Fatigue and health is poor with no improvement; most effects seem to be getting worse instead of improving each day. Patient was not COVID tested post vaccination. It was reported that no treatment was provided for the events. Outcome of the event 'had some itchy skin and redness an hour after shot, especially on both arms' was recovered on 09Feb2021; outcome of the event 'spontaneous bleeding under skin by right eye' was recovered; outcome of the remaining events was not recovered.
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| 48 | 2021-03-22 | vomiting | Seizure the next day plus headaches, tremors and vomiting. |
| 48 | 2021-03-27 | nausea |
feel like I have a chest cold.; feeling like I had the flu; trouble breathing; fatigue; throat has b...
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feel like I have a chest cold.; feeling like I had the flu; trouble breathing; fatigue; throat has been a little sore; cough; feel like allergies all flared environmental and food; nausea; felt horrible; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ENG199), via an unspecified route of administration in the left arm on 04Mar2021 at 17:30 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis, vestibular migraines, allergies to all tree nuts, sunflower oil 25 very high, milk and egg whites, environmental allergy, the patient was recently vegan due to an anaphylactic attack. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included hydroxychloroquine, varenicline tartrate (CHANTIX), escitalopram oxalate (LEXAPRO), lisdexamfetamine mesilate (VYVANSE), metronidazole (TRIAM). There was no other vaccine administered within 4 weeks of the vaccination. On 05Mar2021 at 00:00, the patient woke up feeling like she had the flu. She had trouble breathing and felt like she had a chest cold. She felt fatigue and horrible. This reminded her of how she felt when she had strep throat. Her throat had been a little sore, she had a cough and nausea. She also felt like her environmental and food allergies flared. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "feel like I have a chest cold", "feeling like I had the flu", trouble breathing, fatigue, throat has been a little sore, cough, "feel like allergies all flared environmental and food", nausea and felt horrible was resolving.
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| 48 | 2021-04-01 | vomiting |
Seizure that lasted about 10-15 minutes the next day; Headache; throwing up; arm tremors; not feelin...
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Seizure that lasted about 10-15 minutes the next day; Headache; throwing up; arm tremors; not feeling well; sore arm; This is a spontaneous report from a patient. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration, administered in Arm Left first dose on 16Mar2021 09:30 at single dose for COVID-19 immunization. The patient's medical history included Epilepsy. The patient was not pregnant at time of vaccination. The patient's concomitant medications included oral levetiracetam (KEPPRA) for epilepsy at 4000 mg, daily, valproate semisodium (DEPAKOTE) for epilepsy at 500 mg, daily, and valproate semisodium (DIVALPROEX) for epilepsy at 500 mg. The patient stated that she got the vaccine on 16Mar2021. The patient had a a seizure that lasted about 10-15 minutes the next day on 17Mar2021 at maybe 11pm-1130pm. The patient was out with someone and he took her back to her house and she wasn't feeling like, not normal, and he told her she needed to go to the hospital and it took her awhile as she doesn't realize she had a seizure and it sometimes takes a while to convince her she did. States sometimes with seizures you don't remember. The patient was advised to go to the ER to get checked out and he was really worried. States immediately after the seizure she threw up and was not feeling well at all. States she was not admitted to the hospital. States they did a Ct scan of her head and she had bit her tongue a little bit, which is normal with seizures. States she is improved but she still has the medical condition of epilepsy. The patient stated that after she drove home she noticed when she stretched her arm out she was still having tremors and these for lasted about an hour and then she went to sleep. Caller clarifies that after the hospital she went home and went to sleep. States she had been given Ativan at the hospital to ward off additional seizures and that makes you very tired. The patient also had headaches and still gets them, states they are getting less and less frequent. States the headaches started that same evening, that it was weird she had gone out to dinner and was talking with her friend and she thought I have a headache and he is normally fun and she was not feeling so good. Relays that she thought maybe it was a problem with the food she ate, but states they ordered the same meal and she in confident it is not the food as he did not have any troubles. The patient hasn't had a seizure since age 14 and had she known the vaccine would likely cause one she would not have taken it. States she will not take the 2nd one. She said that this was ridiculous. States her arm was sore like from the flu shot or a little worse, but not a big deal. . States her main concern is the seizure. States she is a CPA and it is her busy season for tax returns and saying her arm being sore is eh maybe she wasn't waving it around as much as normal, she is like a praying mantis at her computer typing away. States the soreness started by the end of the work day or that afternoon. States it was no big deal and the next day she did work around the house and was using that arm more and then working from home that day thank God and it was St. Patrick's day and she went out to dinner. States she only noticed the arm soreness/sore arm 16Mar2021 and by the morning of 17Mar2021 she didn't notice it anymore. States she wasn't told she was at risk for a seizure and that would have been helpful as if she had known there was a chance of a seizure she would, like any medication, if there is a chance of seizures she doesn't take it. The outcome of the event Seizure was not recovered. The outcome of the event headache was recovering. The outcome of the event Pain in extremity was recovered on 16Mar2021. The outcome of the remaining events was unknown. Information about the lot/batch number has been requested.
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| 48 | 2021-04-03 | decreased appetite, abdominal discomfort |
Onset of symptoms was 24 hrs after vaccine. First symptoms were fatigue, abdominal discomfort, loss...
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Onset of symptoms was 24 hrs after vaccine. First symptoms were fatigue, abdominal discomfort, loss of appetite, mild dizziness, swollen injection site, arm soreness. Starting 48 hours after the vaccine: jaundice symptoms, including: itchiness on the feet and palms, large patchy bruises on the legs, clay-colored stools, extreme fatigue, yellowing of the eyes, dark-colored urine. Later, small, round, skin lesions emerged and spread , starting around March 11, 2021. By the 23, red, itchy, patches had expanded over the chest, abdomen and groin areas.
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| 48 | 2021-04-07 | nausea, vomiting |
presented to EC and admitted to hospital for nausea and vomiting the night she received vaccination,...
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presented to EC and admitted to hospital for nausea and vomiting the night she received vaccination, admit to hospital until 4/5 for deconditioned state
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| 48 | 2021-04-09 | diarrhea |
3 minutes - racing heart, then dry mouth 7 minutes dizziness and legs weak with low BP, 15 minutes h...
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3 minutes - racing heart, then dry mouth 7 minutes dizziness and legs weak with low BP, 15 minutes headache and photophobia, 12 hours worsening weakness moving into arms, following day diarrhea, blurred vision, by the 2nd day constipation dysuria, worsening ataxia by day 3, 1 week after unable to move R leg, admitted to hospital 4/1 and discharged next day. Readmitted 4/6 unable to move arms and move bowels/urine.
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| 48 | 2021-04-09 | nausea |
passed out; severe dizziness with nausea feeling; severe dizziness with nausea feeling; huge knot on...
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passed out; severe dizziness with nausea feeling; severe dizziness with nausea feeling; huge knot on head that is swollen and bruised; cut on my left side of neck; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7533), via an unspecified route of administration in left arm on 24Mar2021 at the age of 48 years old at a single dose for COVID-19 immunisation. Medical history included asthma controller, anxiety. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously took morphine and experienced allergy. Approximately 15hrs after receiving vaccine, On 25Mar2021 at 01:15, patient had severe dizziness with nausea feeling sat down and then passed out waking up after (unknown length of time) on the floor. Patient stated "i had struck my head and my left neck/shoulder on table and wall. Now I have huge knot on head that is swollen and bruised and a cut on my left side of neck." Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The outcome of the events was not recovered. Follow-up Information has been requested.
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| 48 | 2021-04-12 | nausea, vomiting | n/v/headache and presented to UC @ 8pm on 4/11/2021 |
| 48 | 2021-04-16 | vomiting, nausea |
Patient reported severe headache on 2/12/21 at approximately 3:30 pm followed by vertigo, nausea, vo...
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Patient reported severe headache on 2/12/21 at approximately 3:30 pm followed by vertigo, nausea, vomiting. Patient became unconscious and EMS was called, found patient on floor and she was brought to ED where CT revealed intracranial hemorrhage. Patient was admitted and supportive care given. She had worsening status on 2/17/21 with pupillary reflexes no longer present and withdrawal of care was performed on 2/21/21. Patient expired on 2/22/21.
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| 48 | 2021-04-17 | nausea, vomiting |
Fainted; Fever 101.6; Vomiting; Nausea; Dizzy; This is a spontaneous report from a contactable consu...
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Fainted; Fever 101.6; Vomiting; Nausea; Dizzy; This is a spontaneous report from a contactable consumer reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN 9581/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 10:45 (at the age of 48 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included lupus, scleroderma, Mixed connective tissue disease (MCTD), and high blood pressure (HBP). The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine 200 mg, and losartan 50mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 19:00, the patient experienced fainted, fever 101.6, vomiting, nausea and dizzy. The patient did not receive any treatment for these events. The outcome of the events fainted, fever 101.6, vomiting, nausea and dizzy was unknown. Since the vaccination, the patient had not been tested for COVID-19.
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| 48 | 2021-04-20 | nausea |
became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin...
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became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; nauseous; light headed; chills; flu like symptoms; arm felt sore/arm at site of injection remains sore; at site of injection remains sore and itchy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (lot number: ER8733) first dose on 30Mar2021 12:30 PM on left arm at single dose for COVID-19 immunisation. Medical history included IDDM (Type 1 diabetes mellitus) and MS (Multiple sclerosis). Patient is not pregnant. No other vaccine in four weeks. No known allergies. Concomitant medications in two weeks included Insulin for IDDM, dimethyl fumarate (TECFIDERA) for MS. Had vaccine at 12:30pm. At 3am (31Mar2021), arm felt sore and felt both nauseous and light headed as well as having chills and flu like symptoms. Went to bathroom and on way back to bed, became faint and passed out onto the floor. Patient hit chin and jaw so hard it was bleeding and obviously very sore and swollen. It's been nearly a week since that incident and arm at site of injection remains sore and itchy. She still feel nauseous at times and her face is still swollen from falling onto the floor and passing out. She was now fearful of having the second dose on 20Apr2021 as due since her reaction to 1st dose was so severe. The outcome of the events was recovering. No treatment for the events. No Covid tested post vaccination.
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| 49 | 2020-12-31 | diarrhea, nausea |
12/26-Had the vaccine, 27th evening felt nauseated, woke up in the middle of the night with head tig...
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12/26-Had the vaccine, 27th evening felt nauseated, woke up in the middle of the night with head tightness(headache), rigors, hot flashes.28th feeling off and fatigued, continued to feel better as the days went on and on the 31st had diarrhea, rigors, temp of 99.3F, hot flashes, muscle aches now.
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| 49 | 2020-12-31 | nausea |
mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1...
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mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1 day); 3 says after injection: nausea, dizziness and weakness, headache, tiredness, feeling unwell.
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| 49 | 2021-01-03 | abdominal pain upper, vomiting, nausea |
10 min after initial injection, I experienced a brief flush of heat that resolved after a few minute...
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10 min after initial injection, I experienced a brief flush of heat that resolved after a few minutes. 6 hours later, I had a sudden onset of intense heat, diaphoresis, and a rash to my arms/legs, along with intense muscle tremors, nausea, vomiting and stomach cramps.
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| 49 | 2021-01-03 | nausea |
12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit ...
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12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit to wrist. All over fatigue, joint pain, brain fog, and temp of F. Nausea and headache. 12/30 - Pain in left worse, incressed pain, redness, and swelling at injecition site. Painful swollen area in left armpit. Pain with any movement of left arm. Headache, fatigue, nausea, and muscle weakness. 12/31 - Continued pain in left arm, but improved. Continue to have pain swollen area with warmth and redness size of an orange. Headache and fatigue. 1/1 - fatigue, arm sore. Bilateral arm weakness. 1/2 - headache throughout day, not responsive to Tylenol or Advil, fatigue 1/3 - Vertigo, fatigue 1/4 - Left arm slightly sore to touch, fatigue.
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| 49 | 2021-01-03 | nausea |
Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. S...
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Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. Symptoms are ongoing. Also, complaints of insomnia (ongoing), joint pain (day after vaccination), right lower quadrant pain (first night after vaccination), weakness (for 3 days after vaccination), moderate muscle pain at injection site (resolved after 48 hours), night sweats (ongoing).
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| 49 | 2021-01-03 | nausea, diarrhea |
Intense pelvic/thigh ache started day 2. I still have the ache, but it?s tolerable. I am very fatigu...
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Intense pelvic/thigh ache started day 2. I still have the ache, but it?s tolerable. I am very fatigued. Nausea the first two days, with diarrhea.
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| 49 | 2021-01-03 | nausea |
pain at injection site that radiated down left arm then turned into overall body aches on 1/3 at tim...
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pain at injection site that radiated down left arm then turned into overall body aches on 1/3 at time of injection. Nausea started on 1/4 around 930am. overall fatigue
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| 49 | 2021-01-04 | vomiting |
Received Pfizer covid 19 vaccine 1/2/21(Saturday). Bed time Saturday injection site was and still is...
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Received Pfizer covid 19 vaccine 1/2/21(Saturday). Bed time Saturday injection site was and still is tender. Also notice mild body aches at this time. Sunday came home from work w fever chills headache and vomiting
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| 49 | 2021-01-04 | nausea |
difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; ...
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difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering. Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-04 | nausea |
left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some p...
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left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some puffiness; harsh soreness around her both temples and her face; Neck pain; Headache/harsh soreness around her both temples; Feverish; Nausea; Joint pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-Year-Old Female patient received BNT162B2 (lot number: EH9899, expiration date: Mar2021) on the 21Dec2020 on deltoid left at single dose to prevent COVID 19. Medical history included Hypertension and Rheumatoid arthritis. Concomitant medications included losartan for Hypertension and hydroxychloroquine sulfate (PLAQUENIL) for Rheumatoid arthritis. She was experiencing a few side effects that are on the list. However, the one that is not on there and she have never had them before. She think that it is something with her left eye there is some puffiness and there is a little bit of swelling and there is a sensation to touch like a little bit of pain when you touch it. It actually started yesterday (22Dec2020) and she took the vaccine two days ago (21Dec2020) and it is on the same side as her injection. So it is on her left side on her left eye and the injection was given on her left Deltoid. It seems to be getting a little better now though the sensation by touch is not as much as it was this morning or yesterday. So she think like it is like going away but it is just something that she think may be should be looked at as one of the possible side effect. She did get neck pain, headache, and bit of headache. She think she was a little bit feverish and nausea and joint pain and a lot of fatigue. She had a harsh soreness around her both temples and her face was like when smile or laugh it was sore. Patient took Ibuprofen to help with the soreness and the pain. It was 800mg. The outcome of the events was unknown.
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| 49 | 2021-01-04 | nausea, vomiting |
she had a slight headache that turned into a bad headache; threw up/ vomited; Nausea; This is a spon...
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she had a slight headache that turned into a bad headache; threw up/ vomited; Nausea; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER5730) via unspecified route on right upper arm single dose for COVID-19 immunization on 30Dec2020 before 10:30AM, at 49-year-old. Medical history and concomitant medication were not reported. On 30Dec2020, 20 minutes after getting the vaccine, the patient had a slight headache that turned into a bad headache by 11AM. Then she went to lunch at 11:30, and after she ate something, she took ibuprofen, then got back from lunch, worked an hour, and threw up. She vomited between 1 and 1:30PM, and vomited a few times and was done, but could still feel a little nausea, but was not going to go throw up. She checked her temperature but didn't have one. Action taken for BNT162B2 was not appliable. Outcome of the event headache was resolving, outcome of the event threw up/ vomited was resolved on 30Dec2020, outcome of the other event was unknown. It was reported as non-serious.
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| 49 | 2021-01-04 | nausea |
throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it ...
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throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it feels like muscle spasms; extremely tired; soreness in her arm; Chills; Nausea; felt weak/having some weakness; massive headache/mild headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 28Dec2020 11:00 on left arm at a single dose for COVID-19 immunization. The patient was positive for Covid back in Jun2020, it was a bad case that she was hospitalized for 6 days, that she did not have to go on respirator. She stated these days she still struggled with chest pains and still struggled with her taste, she went to the emergency room in Sep2020 with some issues from that. The patient concomitant medications were none. The patient stated she was retired who works security at a hospital that she got her first dose of the Pfizer Covid vaccine yesterday on 28Dec2020. She was calling to report some side effects from the vaccine. She was skeptical about shot but she went ahead and got the vaccine, she took it and waited the 15 minutes and everything was fine except some soreness in her arm, about an hour after the shot, she felt extremely tired, could not even read, by last night she was getting chills, nauseated and weak, all she wanted to do was sleep, she had a massive headache. She kept thinking she was going to have to go to the ER. She woke up this morning and her throat was sore, felt like it may be swelling, felt sick. She took two advil and her headache was better. She was taking tumeric and ginger root and honey with lemon for her throat. She knew she was not sick that it is just the vaccine and she would power through it but wanted to call. She was starting to feel better but still having some weakness, still tired, had pain in the arm of the injection site, a mild headache. She stated these side effects are still ongoing but are improved. She was also having some neck pain started this morning sometime, but does not know exact time, it feels like muscle spasms. Caller wanted to know if because she had Covid before her side effects are so bad. The patient did not do any relevant tests. The outcome of the events soreness in her arm, extremely tired, Headache was recovering, the outcome of the events Chills, Nausea was recovered in Dec2020 and the other events was not recovered.
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| 49 | 2021-01-05 | decreased appetite, nausea |
A couple of hours after the vaccine, I began to have extreme muscle pain, both in the left arm and i...
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A couple of hours after the vaccine, I began to have extreme muscle pain, both in the left arm and in my other arm, back. I became extremely fatigued and felt lethargic. I felt flushed and slightly nauseated, but mostly I felt body pain and extremely tired. This continued through the evening and night. In the morning of 1/6/21, I felt better, but today I still have severe muscle pain in both arms and shoulders and back and neck and I am still fatigued, with some loss of appetite.
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| 49 | 2021-01-05 | nausea | Chills Muscle and joint aches Fever Nausea |
| 49 | 2021-01-05 | nausea | Chills,joint pain,muscle aches,nauseated, headache, sore arm |
| 49 | 2021-01-05 | vomiting |
Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat w...
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Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat was fast; Felt like she had to throw up; Pain in right arm; Does not feel good; It felt like there was oil in her mouth; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 via an unspecified route of administration on 30Dec2020 10:45 at single dose in right arm for COVID-19 immunization. The vaccination was given in hospital, not a military facility, at 10:45 and left hospital at 11:05 on 30Dec2020. Prior vaccinations within 4 weeks was none. Additional vaccines administered on same date of the Pfizer suspect was none. Medical history included ongoing migraine and family medical history included mother has high blood pressure and father has diabetes. Concomitant medication included verapamil from Oct2020 at 40 mg twice daily by mouth for migraine. Additional Information for concomitant products Verapamil included 1 for one week, 2 for second week 3rd week 3 and after 3 months, then came back down to 2. The patient experienced does not feel good at 11:30 on 30Dec2020. She was driving and did not feel good. She felt like she had to throw up at12:00 on 30Dec2020 and had it all night until she went to bed. Eyes were red when she woke up at 23:30 on 30Dec2020, that's when she first noticed. Heartbeat was fast around 12:30 on 30Dec2020. Tiredness and needed to sleep extra at 17:00 on 30Dec2020. Pain in right arm at 12:00 on 30Dec2020. When she went to drink something, she noticed her arm was painful. No ER or physician's office required. Received call from patient regarding the COVID vaccine. She received it on 30Dec2020 (yesterday) and was a healthcare worker. She later stated she works in patient transportation in a hospital. She did not feel good. Yesterday, she felt like she had to throw up. When she slept, she felt very tired and when she woke up, her eyes were red. She washed her face when she woke up around 11. Then she noticed her heart beat was kind of fast. She took another medication she takes all the time. Her doctor said that she can take it with it but she was not sure. She did not feel herself. Yesterday after she took it, she had to wait there for 15 minutes. It felt like there was oil in her mouth. She just drank water and came home. When she came home, her heart beat was fast. She had to sit down. She liked to eat spicy food, and she needed to sleep. Her kids said she never slept like this. Both eyes were red, red like blood. Her daughter told her to go look at them in the mirror. There was no pain or nothing in her eyes, they were just red and they improved today. If she goes to bed now, she can sleep, but she just wakes up and drinks tea and wants to wake up. She didn't want to sleep, but she felt like she could. Regarding the pain in her right arm, she had to hold her shoulder when she first woke up. It was worse then, but it's better now that she keeps moving it. She has 3 more weeks to get the next dose of the COVID Vaccine. Hopefully it will be this shot only and she can go back to work. She planned on going back to work on Saturday. She would like to know if she can continue to take Verapamil. She will call her pharmacy to find out. The outcome of the events does not feel good and tiredness and needed to sleep extra was not recovered. The outcome of the events felt like she had to throw up, eyes were red, heartbeat was fast and pain in right arm was recovering. The outcome of the other event was unknown. Information on Lot/Batch Number has been requested.
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| 49 | 2021-01-05 | abdominal pain upper |
Fever (101F), body aches, joint pain, headache, left upper abdominal pain (under base of ribs) all l...
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Fever (101F), body aches, joint pain, headache, left upper abdominal pain (under base of ribs) all lasting apx 16hrs. Then the next 24 hrs just mild HA and some body aches.
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| 49 | 2021-01-05 | decreased appetite, nausea |
I had the vaccine on the 23rd December I was monitored for 15 mins. My throat felt scratchy and itch...
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I had the vaccine on the 23rd December I was monitored for 15 mins. My throat felt scratchy and itchy, I left at 3pm by 3:15 my head started hurting, mild. at 7pm I had a pounding headache, chills, body aches on the 24th AM I could not warm up my body was shivering I went to work at 8 am I thought I had a fever and I checked it was 100.2 when I got home my temp was 101 and 102.9 and my body aches were horrible I couldn't move nausea no appetite, shortness of breath, I did a telemed and talked to my primary and she said this was all related to the vaccine, she prescribed something for the nausea was asked to get a covid test and it came back negative, I started getting better Dec 27th .
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| 49 | 2021-01-05 | vomiting, nausea |
Night sweats followed by chills and rigors, followed by severe headache and nausea/vomiting from 2AM...
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Night sweats followed by chills and rigors, followed by severe headache and nausea/vomiting from 2AM on 1/5/2021 to 0730 1/6/2021. Massive headache still lingering.
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| 49 | 2021-01-05 | nausea |
bp 100/54 synocopalepisode; experienced nausea, was anxious prior to injection; states this has happ...
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bp 100/54 synocopalepisode; experienced nausea, was anxious prior to injection; states this has happened with another injection in past. is now awake, alert and oriented; 911 called-evaluated by ems; refused transport; observed an additional15 min. s/s resolved; denies sob, rash, edema, etc.
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| 49 | 2021-01-05 | nausea |
nausea; chills; malaise; This is a spontaneous report from a contactable nurse reported for herself....
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nausea; chills; malaise; This is a spontaneous report from a contactable nurse reported for herself. A 49-year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via unspecified route of administration at left arm on 23Dec2020 15:30 at single dose for Covid-19 immunization in a hospital facility. Medical history included Sjogren's syndrome, and chronic sinusitis. The patient was not diagnosed with COVID-19 and did not receive other vaccine in four weeks prior to Covid vaccination. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL), colestyramine (questran), lifitegrast (XIIDRA), and chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX); all from unspecified date for unspecified indication. The patient previously took codeine and Ceftin; both experienced allergies. On 26Dec2020 08:00 three days after receiving vaccine, the patient experienced nausea, chills and malaise. The symptoms lasted for four days (Dec2020). The patient has not been tested for Covid-19 since the vaccination. The patient received no treatment due to the events. The outcome of the events nausea, chills and malaise was recovered. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.
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| 49 | 2021-01-06 | vomiting, nausea |
12:14pm Received vaccine and returned to office after 15 minute observation period. 2:30pm developed...
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12:14pm Received vaccine and returned to office after 15 minute observation period. 2:30pm developed headache, 3pm developed nausea, vomiting and dizziness, flushing of skin. Rapid Response called at 3:52pm and patient sent to Emergency Room at 4pm. VS on arrival were BP 144/105, HR 146, RR 22, T 97.9, O2 sat on Room air 98%. ED treatment included IV of 0.9NS (1L), EKG, IV Zofran 4mg, IV Benadryl 25 mg, IV Ativan 0.5mg, IV Compazine 10mg. Also had CT head.
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| 49 | 2021-01-06 | nausea |
@12:45pm Pt c/o slight dizziness w/nausea, blurred vision after 5 minutes and diaphoretic, obtained ...
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@12:45pm Pt c/o slight dizziness w/nausea, blurred vision after 5 minutes and diaphoretic, obtained v/s (stable) assisted laying down on stretcher. Bottle water offered and took several sips. Â @12:54pm Dr arrived for provisder Assessment and noted stable just continue monitoring. Waiting for longer observation for 20 more minutes. Pt states,"I feel a lot better." Â Pt taking Ceftriaxone currently and finished prednisone x2 days after a course of several days. Â Pt advise to call if s/sx return or get worse. Â Allergies updated and Covid-19 vaccine added, suggested "not recommended for 2nd dose" and 2nd dose appt canceled.
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| 49 | 2021-01-06 | vomiting |
About an hour after the injection I had pain and burning going down my left side and in the left sid...
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About an hour after the injection I had pain and burning going down my left side and in the left side of my chest that lasted about 45 min. I was fine for the next 12 hr. Around midnight I started with chills, joint pain body aches and a headache. I woke up around 2 am with a fever. All day on the 6th I felt horrible with body aches, joint pain and a severe headache. Around 10 pm on the 6th I started again with chills fever chest pain SOB Cough and vomiting (3 episodes throughout the night.) My lungs currently feel like they are on fire and I continue to have chest tightness, joint pain Severe headache and a cough. I am approximately 56 hr post second vaccination. I had no problems with the first vaccination
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| 49 | 2021-01-06 | nausea, diarrhea, abdominal pain |
Fever, chills, feet felt frozen-Sat day & evening w/ABD pain Exhausted-she slept, next day Sunday@02...
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Fever, chills, feet felt frozen-Sat day & evening w/ABD pain Exhausted-she slept, next day Sunday@02 or 03 sleeping clothes all wet-she had to change her clothes, Sunday-she feels drained, She laid in bed Saturday & Sunday drank water and took Motrin. Monday-too weak to work. Body aches, headache. Monday severe ABD cramps-heating pad to help/nauseated. Tuesday diarrhea starts. Wednesday-left side of her back-pain-diarrhea & Tired. No SOB. Drinking Pedialyte and taking Motrin-she said IF she gets worse she will go to the Urgent Care-near her home.
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| 49 | 2021-01-06 | vomiting, nausea | Headache & NauseaVomiting Narrative: |
| 49 | 2021-01-06 | nausea |
Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad...
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Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad (Still having some of these problems)
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| 49 | 2021-01-06 | nausea |
Nausea, tick to mouth, headache, muscle aches, fatigue, bruising, chills and low grade fever of 99.4...
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Nausea, tick to mouth, headache, muscle aches, fatigue, bruising, chills and low grade fever of 99.4 beginning at 8PM on 1/6/2021. Vaccine given at 7:30 AM on 1/6/2021. Still experiencing body aches as of 10am on 1/7/2021 but all other symptoms have improved. No treatments given.
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| 49 | 2021-01-06 | nausea, vomiting |
NauseaVomiting Narrative: Seen in the ED for nausea with 1 episode of vomiting after receiving COVI...
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NauseaVomiting Narrative: Seen in the ED for nausea with 1 episode of vomiting after receiving COVID- 19 vaccine. Questionable covid 19 vaccine reaction of nausea. No evidence of serious allergic reaction, no rash, no trouble breathing. Nausea improved with zofran. No indication for benadryl or other allergy medications at this time. Patient has been observed in the ER for several hours and no new symptoms developed. Will DC home with strict return precautions.
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| 49 | 2021-01-06 | difficulty swallowing |
throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallo...
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throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallowing; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1685) as the first dose via an unspecified route of administration in the left arm on 29Dec2020 06:00 for COVID-19 immunization. Medical history included fibromyalgia, asthma, prediabetes, and carpal tunnel syndrome. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no previous allergies to vaccines. The patient allergies to medications which included: doxycycline, medroxyprogesterone acetate (DEPO-PROVERA), metoclopramide (REGLAN), gluten. The patient initially had headache, dizziness and irritability, throat tingling, throat swelling, and difficulty swallowing started around 12 hours after injection, event onset date reported as 29Dec2020 18:00. The events resulted in emergency room/ department or urgent care. The events were reported as non-serious by HCP. Treatment received for the events included diphenhydramine and hydroxyzine embonate (HYDROXYZINE PAMOATE). The outcome of the events was recovering.; Sender's Comments: The reported pharyngeal swelling together with other symptoms was likely related to the single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 49 | 2021-01-07 | nausea |
12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand ...
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12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand and face swelling, swelling and tenderness around injection site, general flu-like symptoms making it difficult to sleep. I was able to go to work the next morning despite symptoms. Symptoms, other than mild soreness in arm where injected, resolved 36 hours after onset.
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| 49 | 2021-01-07 | nausea | Nausea, Headache, Fever, Sweats, Sore Arm |
| 49 | 2021-01-07 | nausea, diarrhea |
Reported Temp 100.6F, difficulty sleeping, dizzy, lightheaded, flushed , nausea with diarrhea for 12...
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Reported Temp 100.6F, difficulty sleeping, dizzy, lightheaded, flushed , nausea with diarrhea for 12 hours. All symptoms resolved. Patient Included the following information: 1 st dose Phizer EH 9899 2nd Dose Phizer EK 9231
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| 49 | 2021-01-07 | difficulty swallowing | Sore Throat Hard to Swallow Throat hot Headache |
| 49 | 2021-01-07 | nausea, diarrhea |
Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarr...
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Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; This is a spontaneous report from a contactable health care professional nurse, the patient. A 49-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899) in the left arm on 22Dec2020 14:30 as a single dose, for COVID-19 immunization. Medical history includes Lupus, Endometriosis, Epilepsy from an unknown date and unknown if ongoing. Concomitant medication included belimumab (BENLYSTA), prednisone (PREDNISONE), topiramate (TOPAMAX), levetiracetam (KEPPRA), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). The patient previously took Percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol], Sulfa Drugs and hibiclens and experienced drug hypersensitivity. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient experienced sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea on 23Dec2020 07:00. Events continues through now 10 days later and still feel horrible. The events resulted in a physician office visit. The patient underwent lab tests that included SARS-CoV-2 test Nasal Swab (Both rapid and PCR) on 30Dec2020; influenza test and Streptococcus test on an unspecified date. The results of all laboratory tests influenza Streptococcus test and COVID (Both rapid and PCR) were negative. No treatment was received given for the events. The clinical outcome of sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea was not recovered.
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| 49 | 2021-01-07 | nausea |
Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepc...
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Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepcid, prednisone
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| 49 | 2021-01-08 | decreased appetite, diarrhea, abdominal pain, abdominal pain upper, nausea |
01/08/21: Sudden onset of extreme body/muscular pain, such that moving was difficult. Extreme chills...
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01/08/21: Sudden onset of extreme body/muscular pain, such that moving was difficult. Extreme chills, headache. Needed pain medicine to alleviate pain. Fatigue. 01/09:21: AM: Less body pain , but feeling of heaviness in head; weak. PM: Had onset of lower GI symptoms: painful abdominal/cramps, stomach pain, nausea. No vomiting, but had several episodes of diarrhea. Feeling like passing out but never did. Loss of appetite. Slowly resolving.
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| 49 | 2021-01-08 | difficulty swallowing |
After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light ...
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After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light headed and as if I was drunk my legs feel real week they took me outside so I could catch some fridge fresh air and they set me down on a chair I was very dizzy my legs and my knees felt like I couldn't stand up and they were very weak I kept seeing a the rails double vision and I started to have a tightness in the back of my neck I felt they warrant come over my head and my forehead got very very cold And then I felt as I was gonna blackout and pass out and I was gasping for air and suddenly my tongue went into a spasm and it went to the top of my the roof of my Roof of my mouth and I couldn't breathe and I was able to send a message for someone to come and help me as I was sitting there by myself they rushed over by now looking at my text message it was for 02 which was within 15 minutes of the vaccine when I had my 1st episode and then minutes after that 3 more came with the same oh unable to swallow I lost the ability to swallow and my tongue fell like I had no control it was just automatically stuck to the roof of my mouth.. Upon the arrival of Ems I was told there was no treatment and there was nothing they could do told me to wait 24 to 48 hours in the symptoms should subside it's been over 72 hours in the symptoms are still occurring. I continue to feel dizzy light headed and now have high blood pressure which was not present before visit ER prescriptions for steroids with issued, I Told to go home and rest. Followed up with family doctor in the morning and was told it was not an allergic anaphylactic reaction probably more so neurologically ransom blood tests waiting for results continue to have loss of control over tounge spasms unable to eat Accompanied by fatigue dizziness and high blood pressure
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| 49 | 2021-01-08 | nausea, diarrhea |
Day one I had a headache. Wouldn?t go away with any medication. Day 6 still had headache turned into...
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Day one I had a headache. Wouldn?t go away with any medication. Day 6 still had headache turned into migraine and severe exhaustion. Chills, diarrhea and nausea. Day 10 woke up in the middle of the night with fever 99.6. At this point I went and got tested for Covid and it was negative. Finally on 09/09/2021 woke up without a headache but it came back later on.
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| 49 | 2021-01-08 | nausea |
Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphor...
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Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphoresis, then unable to stand, fell to the floor then could not see at all, everything was black, also unable to speak, sudden onset of shortness of breath, central chest pain, pain to shoulders and neck. Ears ringing, pain to back of head. Approximately 15 min later was able to speak and crawl to edge of bed. Sweating remained at this time along with extreme weakness, lightheaded and nausea. Heart rate 118, oxygen was 96% by finger oximeter. 10 minutes later dressed with assistance and able to ambulate independently but slowly to truck to be taken to ER.
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| 49 | 2021-01-08 | nausea, vomiting | Headache & NauseaVomiting Narrative: |
| 49 | 2021-01-08 | abdominal pain, vomiting |
Received vaccine 12/19/2020 at hospital around lunch time. Severe abd pain started 10 hours after va...
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Received vaccine 12/19/2020 at hospital around lunch time. Severe abd pain started 10 hours after vaccine administration with vomiting. I went to emergency room next morning Emergency appendectomy 12/20/2020. Had bleeding after surgery. Second surgery 12/21/2020
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| 49 | 2021-01-08 | diarrhea, vomiting, nausea | UrticariaPruritus, Diarrhea & NauseaVomiting |
| 49 | 2021-01-08 | diarrhea, nausea, vomiting |
mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vo...
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mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vomiting, diarrhea, itching This started at minute 13 after the vaccine administration. I have had several infusion reactions before to biologics to treat my autoimmune disease and this is how it always starts. There was nothing available at the administration place so I left and took zyrtec, benadryl and pepcid. The symptoms stopped in about 25 minutes.
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| 49 | 2021-01-09 | abdominal pain upper, diarrhea | Stomach cramping, diarrhea, fatigue. |
| 49 | 2021-01-10 | abdominal pain | ABDOMINAL PAIN, CRAMPING |
| 49 | 2021-01-10 | nausea |
After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mi...
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After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mild headache that was intermittent. I had malaise and fatigue. I took some cold medicine 3 times in the course of 24 hours and woke up the next morning with none of those symptoms but did have lympadenopathy under my left arm that decreased through the course of the day. It was painful to touch and tender once the lymph node decreased in size. The only other reaction was the site pain and tenderness and warmth. That lasted a few days.
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| 49 | 2021-01-10 | nausea, decreased appetite |
her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all ...
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her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all sick, cold, sick and experiencing terrible side effects; Fatigue; Muscle ache; Nauseous; Felt awful; Can't eat all the day, no appetite; phobic something to drinking water; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (lot/batch number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. The patient experienced getting all sick, cold, sick and experiencing terrible side effects, fatigue, muscle ache, nauseous, cannot do anything, felt awful, cannot eat all the day, no appetite, phobic something to drinking water. The patient has been sick for three days now. The patient was a "senior" (not clarified) care giver at the nursing home. Everybody at nursing home at the nursing home got the shot and now everybody has cold and sick. She has only one day of work and she has to come into her job to take care of elderly people. As since current everybody is experiencing the terrible adverse, terrible side effects, everything. Fatigue, muscle ache everything. The bosses at her nursing home cannot give them three days or even seven days off of work after receiving a contract to give them shot. It was confirmed that the patient received the COVID vaccine. The patient also stated that they are off of that side effects. They are not interrupted not just the "arm" (not clarified) been there. The patient said she getting everything. She was getting all the side effects. So when they had this Pfizer drug shot "they didn't get seven days off of" (not clarified) work. If a person gets a shot, they are feeling fatigue, nauseous (incomprehensible voice). They can't do anything. They should be allowed to stay home from work. Right now everybody in the nursing home is feeling the adverse effect. The entire building. So, she was telling Pfizer to report the report is that all of sudden that the nursing home "seniors" (not clarified) and nurses they got the shot, they can't even get to work. The effects are so bad that they can't do anything. The patient also stated that fatigue, she had fatigue all day. The first day she got the shot her nerve was bad but the second day was everything fatigue. She felt awful, she could not eat, she had no appetite. She was phobic something to drinking water, she cannot eat all the day. "Fruit or something 5 I can eat" (incomprehensible voice)." When probed for the LOT#, the reporter stated, "No they did not give me anything. All they did is I think 037 I think it looks like a 'K' 20A. (further not clarified) like it says (further not clarified) 037K20A that's (further not clarified)." The outcome of the events was unknown. Information on lot number/batch number was requested.
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| 49 | 2021-01-11 | nausea |
1st vacccine onset headache 30 mins, discomfort arm and tired. 2nd Vaccine onset headache 30 mins We...
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1st vacccine onset headache 30 mins, discomfort arm and tired. 2nd Vaccine onset headache 30 mins Wed, Thursday neck shoulders blades hurt, and achy. Friday Chills, no fever, hurt to the bone all over, sick to stomach, noticed some lips swollen, felt foggy in head. Headache constant top of head. 10:45am spots and vision blurry. Felt very sick. Laid head down then woke black spots. Sat occasionally in sun saw black spots. /sun off not looking at computer did not see black spots. Monday increase black spots. Saw an eye doctor.
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| 49 | 2021-01-11 | diarrhea, nausea, vomiting |
Elevated blood pressure and headache at immediate injection body aches about 2 hours later follow by...
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Elevated blood pressure and headache at immediate injection body aches about 2 hours later follow by nausea low grade temp. On Sunday about 4am I started vomiting with diarrhea, joint pain, Headache, BP of 168/109 and temperature of 100.1.
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| 49 | 2021-01-11 | diarrhea |
Mild chills the day after. Muscle aches day 2 (mild). Diarrhea day 3 (mild). Injection site swollen ...
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Mild chills the day after. Muscle aches day 2 (mild). Diarrhea day 3 (mild). Injection site swollen and red and sore (mild)
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| 49 | 2021-01-11 | vomiting, nausea |
painful swollen red arm shoulder to elbow joint and muscle pain sore throat low grade fever 99.5 nau...
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painful swollen red arm shoulder to elbow joint and muscle pain sore throat low grade fever 99.5 nausea vomiting shortness of breath headache some periods of confusion
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| 49 | 2021-01-12 | nausea |
About 10 minutes into observation, she felt very nauseated, and then reported being dizzy. She repor...
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About 10 minutes into observation, she felt very nauseated, and then reported being dizzy. She reported "having waves of dizziness" that "made me feel like she was going to pass out but was clearly not" also reported "dizzy spots" in her vision. She had 3 separate episodes, each lasting about 4-5 minutes each. BP @ onset 100/63, pulse 57, after resolution, 100/62, pulse 62. O2 sat 100%. All symptoms resolved after a total of 30 minutes post vaccination.
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| 49 | 2021-01-12 | nausea |
Nausea; Headache; This is a spontaneous report from a contactable healthcare professional (patient)....
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Nausea; Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old female patient received the first dose of bnt162b2 (COVID-19 vaccine, brand: Pfizer-BioNTech) lot no: EH9899, intramuscular in left arm on 06Jan2021 01:00 at a single dose for Covid-19 immunization in a hospital. The patient medical history and concomitant medications were not reported. The patient was not pregnant and no known allergies. No other vaccine was administered in four weeks. No Covid prior to vaccination and was not Covid tested post vaccination. The patient experienced nausea and headache on 06Jan2021 18:00. The events were reported as non-serious. Treatment was not given for the events. The patient was recovering from the events.
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| 49 | 2021-01-12 | nausea | Tingling on tongue and lips, fever 101.0, nausea |
| 49 | 2021-01-12 | nausea |
about 4 hrs after vaccination ee had "tunnel vision" dizzy, abd upset, "churning stomach" gas, No ...
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about 4 hrs after vaccination ee had "tunnel vision" dizzy, abd upset, "churning stomach" gas, No diarrhea but soft stools. today headache, and fatigue
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| 49 | 2021-01-12 | diarrhea, nausea |
chills which lead to shivers and putting on 3 layers, 2 down comforters and a throw blanket to go to...
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chills which lead to shivers and putting on 3 layers, 2 down comforters and a throw blanket to go to sleep, fever (I can't remember what it was), sweating (even after taking layers and blankets off), fatigue, arm swelling, and pain where the injection was, nausea, unable to stand for short periods of time, This lasted over 24 hours, the next day the same but on a lesser progression but included diarrhea and a swollen supraclavicular lymph node being swollen-- > 5"x2".
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| 49 | 2021-01-13 | abdominal pain upper, nausea |
Body ache; fatigue; Weakness; Abdominal noises; Sick to her stomach/super sick stomach; Not feeling ...
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Body ache; fatigue; Weakness; Abdominal noises; Sick to her stomach/super sick stomach; Not feeling good; awful stomach ache; could not eat/she can't eat; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. Medical history included ongoing overweight. Concomitant medications were not reported. The patient experienced sick to her stomach/super sick stomach on 03Jan2021 with outcome of unknown, not feeling good on 03Jan2021 with outcome of unknown, awful stomach ache on 03Jan2021 with outcome of unknown, could not eat/she can't eat on 03Jan2021 with outcome of unknown, body ache on 07Jan2021 with outcome of unknown, fatigue on 07Jan2021 with outcome of unknown, weakness on 07Jan2021 with outcome of unknown, abdominal noises on 07Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: unknown on 05Jan2021. Therapeutic measures were taken as a result of sick to her stomach/super sick stomach (nausea) and included treatment with Pepto-Bismol.
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| 49 | 2021-01-13 | vomiting, nausea |
Fever; chills/rigors; Severe myalgia; Nausea; vomiting; Severe headache; This is a spontaneous repor...
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Fever; chills/rigors; Severe myalgia; Nausea; vomiting; Severe headache; This is a spontaneous report from a contactable physician (patient). A 49-year-old female patient (no pregnancy) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), with first dose (lot number: ACEK5703) at 16:00 on 16Dec2020 and with second dose (lot number: EK9231) at 16:00 on 06Jan2021, both intramuscularly at site of left arm at single dose for COVID-19 immunization. Medical history reported none. The patient's concomitant medications were not reported. The patient experienced fever, chills, rigors, severe myalgia, nausea, vomiting, and severe headache at 01:00 AM on 07Jan2021. Facility where the most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. The patient received treatment of paracetamol (TYLENOL) for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. No allergies to medications, food, or other products. This case was identified as non-serious by reporter. The outcome of events was recovered in Jan2021.
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| 49 | 2021-01-13 | nausea | Patient describes nausea, fatigue and headache. Also has arm soreness, but very mild |
| 49 | 2021-01-13 | nausea, diarrhea |
Severe body aches; headache; nausea; diarrhea; exhaustion; This is a spontaneous report from a conta...
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Severe body aches; headache; nausea; diarrhea; exhaustion; This is a spontaneous report from a contactable nurse. A 49-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 06Jan2021 16:30 at the first single dose for covid-19 immunisation. Medical history included ongoing hypertension , ongoing hypothyroidism , ongoing blood cholesterol increased , Known allergies: Sulfa. The patient's concomitant medications were not reported. The patient experienced severe body aches, headache, nausea, diarrhea, exhaustion on 07Jan2021 03:00. The patient did not receive any treatment for the events. The outcome of events was not recovered. Information on the lot/batch number has been requested.
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| 49 | 2021-01-13 | nausea |
blurry vision 1st day. asthma attack 1st night inhaler worked. next morning. Massive severe headac...
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blurry vision 1st day. asthma attack 1st night inhaler worked. next morning. Massive severe headache (almost as bad as the spinal headache from my 1st child) , chills, fatigue, nausea. Called PCP and he gave me Tylenol with codeine for the headache and a prednisone for the asthma even though it was under control.
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| 49 | 2021-01-14 | nausea |
After second dose of Pfizer COVID-19 vaccine, patient felt nauseous. She did not vomit. She stated s...
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After second dose of Pfizer COVID-19 vaccine, patient felt nauseous. She did not vomit. She stated she has 2 bowel movements, denies diarrhea. She felt very tired. Both her hands felt tingly. BP 117/75 - 85bpm - 98% RA. She was not pale or diaphoretic. No medication given. She slept for ~90 minutes in the vaccination room on the gurney. She felt well upon awaking. Drank water and ate crackers. She left in stable condition.
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| 49 | 2021-01-14 | nausea |
FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAI...
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FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAIN JOINTS,FEVER,NAUSEATE,FEELING BAD.
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| 49 | 2021-01-14 | nausea | Fever >101, nausea, urticaria. Treated for urticaria with steroids, H2 and H1 blockers |
| 49 | 2021-01-14 | difficulty swallowing | fatigue, difficulty swallowing, runny nose |
| 49 | 2021-01-15 | nausea |
dizzy, nausea, headache, myalgia, fatigue, arthralgia, then on 1/14 fever 10.3 headache continued a...
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dizzy, nausea, headache, myalgia, fatigue, arthralgia, then on 1/14 fever 10.3 headache continued arm sore, did call out of work 1/14 took Tylenol and motrin
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| 49 | 2021-01-16 | nausea, abdominal pain upper, decreased appetite |
Sig stomach and gut cramps to the point of near syncope. Missed half day work. Nausea, lack of appet...
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Sig stomach and gut cramps to the point of near syncope. Missed half day work. Nausea, lack of appetite. Lasted over 4 hs severe, 12 hs moderate
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| 49 | 2021-01-16 | nausea |
Thursday 1/14/21 5:30 PM began having chills and body aches. Temperature of 102, taken by ear. Fe...
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Thursday 1/14/21 5:30 PM began having chills and body aches. Temperature of 102, taken by ear. Felt Strange just not well. Ran a fever through the night into the next morning., Friday 1/15/21 had a fever of 100.5 taken by ear. Fever subsided. Began having a slight headache that lasted through Sunday. Also had Nausea that started Friday and continued through today. Sunday. Injection arm has been very sore. I also have a very sore enlarged lymph node under my left arm pit. Markedly swollen.
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| 49 | 2021-01-17 | abdominal pain upper |
I woke up with hills, body aches 12 hrs after 2nd dose. My arm was hurting I expected that was one o...
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I woke up with hills, body aches 12 hrs after 2nd dose. My arm was hurting I expected that was one of the symptom as 1st dose. The following day chills, body ache fever 99.6 took Ibuprofen slept most of the day. On 1/17 started exp stomach cramps (described as the muscles in stomach).
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| 49 | 2021-01-17 | appendicitis, abdominal pain |
Patient experienced abdominal pain on January 12th. She reported having a headache and joint pain as...
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Patient experienced abdominal pain on January 12th. She reported having a headache and joint pain as well. Her temperature was 103.5. On January 14th the patient was admitted for acute appendicitis with perforation, localized peritonitis, and gangrene. Patient was discharged on January 16th post appendectomy.
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| 49 | 2021-01-17 | nausea |
headache, chills ( all day of Jan.17) feels icy cold around my ears and face temp. 97, warm/hot temp...
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headache, chills ( all day of Jan.17) feels icy cold around my ears and face temp. 97, warm/hot temp 98.9, nausea, blurry vision, pass out once 2-3 mins, feverish at night 99.9
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| 49 | 2021-01-17 | nausea |
palms of my hands were bright red; very warm flush feeling; nausea; swelling of the throat; rash on ...
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palms of my hands were bright red; very warm flush feeling; nausea; swelling of the throat; rash on my arms and abdomen; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), intramuscular in the left arm on 06Jan2021 16:00 (at the age of 49 years old) at a single dose for COVID-19 immunization. Medical history included psoriasis, microscopic colitis, allergies to shellfish, and coconut. The patient's concomitant medications were not reported. The patient previously took estrogen patch, etanercept (ENBREL) and sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies to all. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and did not take any other medications with 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 16:15, the patient experienced a very warm flush feeling, nausea started and by 15 minutes, she had swelling of the throat and rash on her arms and abdomen and the palms of her hands were bright red. The events resulted in Emergency room/department or urgent care visit. The patient was treated with diphenhydramine hcl (BENADRYL), steroids (unspecified), famotidine (PEPCID) and ondansetron (ZOFRAN) in response to the events. The patient assessed the events as non-serious. The outcome of the events was recovered with sequel on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-01-18 | vomiting, nausea |
5 minutes after receipt of second COVID vaccine developed rapid onset of nausea, vomiting, body ach...
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5 minutes after receipt of second COVID vaccine developed rapid onset of nausea, vomiting, body aches. Did seek care in the Emergency department where was given IV fluids and Zofran. 18 hours later, feeling improved. Still showing some s/s. First vaccine was on 12-28-20 with Pfizer Lot # EL 1284. 3-4 hours after that vaccine developed headache, Body aches and exhaustion that lasted about 24 hours.
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| 49 | 2021-01-18 | nausea |
Day 1 after injection: injection site soreness Day 2-4 after injection; headache, sleepiness, low g...
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Day 1 after injection: injection site soreness Day 2-4 after injection; headache, sleepiness, low grade nausea - No relieved by IBU 600mg tid for 3 days, sleep. Low grade nausea remains today 9 days post injection.
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| 49 | 2021-01-18 | decreased appetite, vomiting |
Persistent fever >101, vomiting, severe headache, severe joint pain, anorexia, started 12 hours aft...
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Persistent fever >101, vomiting, severe headache, severe joint pain, anorexia, started 12 hours after vaccine and persisting now Day 3 since vaccine. Unable to function for work. Had Covid illness 3/2020. Antibodies still present on blood work one week prior to vaccine. No hx of vaccine reactions in the past.
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| 49 | 2021-01-18 | diarrhea, decreased appetite, abdominal distension |
Severe/Explosive diarrhea for 3 days now, extreme GI pain, bloating, swelling, loss of appetize, fa...
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Severe/Explosive diarrhea for 3 days now, extreme GI pain, bloating, swelling, loss of appetize, fatigue, low back pain and achy all over. Much more severe then after my 1st Covid shot.
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| 49 | 2021-01-18 | decreased appetite, diarrhea |
Woke up shivering at 1 A.M. Saturday so bad that my husband thought I was having a seizure, took my...
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Woke up shivering at 1 A.M. Saturday so bad that my husband thought I was having a seizure, took my temp it was 104. Took Tylenol, held cool compress on my forhead, the next day had bad chills, throbbing headache, and temp never dropped below 100. I was very weak, every muscle in my body ached, couldn't eat, yet my blood sugar was high all day. Kept checking my temp. It was avg. 102 . Read about the side effects, seemed like I just had it worse than others. Then into Monday morning, still felt awful, but had woke up in a pool of sweat, temp finally fell to 99 . Seemed like the worst was past, was able to eat a little breakfast, but then the diahrea started! I called in sick again, and went to Urgent care. The Dr. said I had a severe adverse reaction to the second vaccine. I asked for a Covid test just in case. Now Tuesday, felt better today, still a bit tired, temp has been avg. of 98 today, got results from test, negative.
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| 49 | 2021-01-19 | appendicitis, abdominal pain |
Approximately 5 hours after receiving my 2nd Pfizer Covid shot, I started to get diffuse abdominal p...
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Approximately 5 hours after receiving my 2nd Pfizer Covid shot, I started to get diffuse abdominal pain & back aching. Seen in the ED 1/8/20 - Negative US, Normal labs - returned to ED 12 hours after D/C for worsening abdominal pain. 1/9/21 - CT showed Appendiciticitis
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| 49 | 2021-01-19 | diarrhea |
Day 1, loose stools that night. Day 2, loose stools and a sore throat. Day 3, sore throat and runny ...
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Day 1, loose stools that night. Day 2, loose stools and a sore throat. Day 3, sore throat and runny nose. Day 4, nose runny like a faucet and cough. Day 5, runny nose, sore throat, coughing a lot. Took some Theraflu. Day 6, no more sore throat but coughing and some shortness of breath on exertion and at rest. Day 7, coughing, nose not running as much, shortness of breath still present. Day 8, shortness of breath, coughing a lot. Day 9 (Tuesday, January 19, 2021) still coughing and experiencing Shortness of breath. Texted my manager and explained whatvhad been going on since I got the second vaccine and that I wasn't sick prior to getting it. And that no other family member in my home was sick besides me. She put me in touch with the HR director who scheduled n e for a COVID test that same night. I went to have the test done and also had the ER doctor to evaluate me because I was feeling so bad with the coughing and Shortness of breath. Today, I am still coughing, producing nasal drainage, and feeling short of breath at times.
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| 49 | 2021-01-19 | decreased appetite, nausea |
I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level ...
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I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level was 8 out of 10. When I tried to get out of bed, I was dizzy and had to hold to the walls to make it to the bathroom. I had severe dry mouth, nausea, muscle weakness, loss of appetite and chills. I was unable to go to work. The symptoms did not begin to subside until later in the evening the next day around 6:30pm. Today I am still weak but making it. Still having chills, and some minor muscle aches and spasms.
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| 49 | 2021-01-19 | diarrhea | dizzy headache chills body aches low grade fever diarrhea |
| 49 | 2021-01-20 | nausea |
All of my symptoms occurred later in the evening: Very cold (lasted 1 night) nausea (lasted 2 days) ...
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All of my symptoms occurred later in the evening: Very cold (lasted 1 night) nausea (lasted 2 days) light headed (lasted 1 night) tingling sensation in hands, feet, legs, and arms (this is still happening as of today)
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| 49 | 2021-01-20 | diarrhea |
Employee received her #2 COVID vaccine at 0930. At 0300 on 1/21/2021 she woke up with temp of 101, ...
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Employee received her #2 COVID vaccine at 0930. At 0300 on 1/21/2021 she woke up with temp of 101, chills, bodyaches and pain in the neck and lower back. Diarrhea starting at 0730.
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| 49 | 2021-01-20 | diarrhea |
Headache; Tired; Diarrhea; Sore nipples; Sore injection site; This is a spontaneous report from a co...
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Headache; Tired; Diarrhea; Sore nipples; Sore injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscularly on the left arm on 09Jan2021 (08:15) at a single dose for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 09Jan2021, the patient had headache; was tired; had diarrhea; sore nipples; and sore injection site. The patient did not receive any treatment for the reported events. The outcome of the events, 'headache', 'tired', 'diarrhea', 'sore nipples' and 'sore injection site', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination. Information about lot and batch number was requested.
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| 49 | 2021-01-20 | nausea, decreased appetite, vomiting |
Jan 17: 9pm nausea, then chills, fever of 101-102; dizziness, shaking uncontrollably from chills; vo...
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Jan 17: 9pm nausea, then chills, fever of 101-102; dizziness, shaking uncontrollably from chills; vomited at 5am on jan 18; Jan18 fever and chills continued, no apetite all day; dizzy; weak; severe body aches; confined to bed all day; severe head ache; very sensitive to light; could not sleep for more than 15-45 minutes at a time; food tasted like chemicals or sickeningly sweet; only rice tasted normal; very sensitive to and repelled by odors. Jan 19: nausea abated, started to eat a few things but eveything still tasted terrible except for rice; got tested: covid negative, flu A &B negative, RSV negative; body aches were much worse; difficult to walk due to shooting pain in feet and back; stayed in bed all day; Jan 20 fever broke, now have right side sore throat; still achy and dizzy; Jan 21 still have headache and mild body aches, not confined to bed but too weak and achy to work
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| 49 | 2021-01-20 | diarrhea |
Received Inj on 01-14-2021. That evening had chills, fever, muscle aches began. Took Tylenol and we...
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Received Inj on 01-14-2021. That evening had chills, fever, muscle aches began. Took Tylenol and went to bed. Awoke on 01-15-2021 with severe congestion, dyspnea, fever, chills, diarrhea, muscle aches, back pain, kidney pain, headache, felt exhausted all of which I had when I was Covid positive and to the same severity. Injection site extremely sore, swollen, warm, unable to lay on the injection site. Symptoms began to subside on 01-20-2021 and I returned to work on 01-21-2021. Employee Health representative advised me to complete this form.
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| 49 | 2021-01-20 | nausea |
Sore arm day of. Next day: Headache, extreme fatigue, nausea, low grade fever of 99 these symptoms l...
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Sore arm day of. Next day: Headache, extreme fatigue, nausea, low grade fever of 99 these symptoms lasted until 1/15/21 at 1300.
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| 49 | 2021-01-20 | nausea |
Swelling very red painful growing spot at injection site, beginning a few hours after injection, sor...
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Swelling very red painful growing spot at injection site, beginning a few hours after injection, soreness in entire arm beginning the morning after the injection more severe than with the flu vaccine, nausea two days past vaccination
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| 49 | 2021-01-21 | retching |
Individual felt dizzy and had a severe headache about 15 min post injection of 2nd vaccination. We ...
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Individual felt dizzy and had a severe headache about 15 min post injection of 2nd vaccination. We sat her down and then she said her chest felt tight and said she felt as if her heart was racing. Went unresponsive, still breathing, for almost 1 min. Came to and then began to dry heave. Her breathing became wheezy and rapid and her bottom lip began to turn blue. We administered an EpiPen about 5:03pm and the rescue squad took her to the hospital. They administered Benadryl and Ativan in the ER and sent patient home that evening.
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| 49 | 2021-01-23 | vomiting |
fever of 103 degrees with chills, uncontrollable shaking, vomiting beginning around 8:00 PM, Tyleno...
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fever of 103 degrees with chills, uncontrollable shaking, vomiting beginning around 8:00 PM, Tylenol did not reduce fever, went to ER and was admitted post chest x-ray, CT scan, dopplers. While admitted was treated for adverse reaction and pneumonitis diagnosed in ER. Treatment included iv fluids, iv antibiotics (Rocephin), magnesia, potassium, anti-nausea mediation, breathing treatments, Lovenox injections, blood draws for labs multiple times per day.
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| 49 | 2021-01-24 | decreased appetite |
Fever up to 103, body aches, loss of appetite, all treated with ibuprofen. Fever did not go under 1...
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Fever up to 103, body aches, loss of appetite, all treated with ibuprofen. Fever did not go under 100 for 40 hours. Also had extreme drowsiness (slept 21 of 24 hours).
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| 49 | 2021-01-24 | nausea | Headache, nausea and muscle aches |
| 49 | 2021-01-24 | nausea |
I received my second Pfizer covid vaccine at 4:00 p.m. on 1/14/2021 from a co-worker. At 2:30 a.m. ...
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I received my second Pfizer covid vaccine at 4:00 p.m. on 1/14/2021 from a co-worker. At 2:30 a.m. on 1/15/2021 I woke up with severe rigors that lasted 2 hours. Over the course of the day 1/15/2021 I had a second 2 hour episode of rigors. They were almost violent and seizure-like. In addition, I had severe nausea, dizziness, decreased vision, fever, myalgia, and exhaustion. My temperature reached 103.4 and lasted over 24 hours. Ibuprofen would bring the fever down 1 degree and helped decrease rigors, but did not help the headache. On 1/16/2021 I developed redness and swelling of entire upper left arm, and edema in arm pit. I spent three days unable to work or sit up in a chair. Symptoms began to decrease after three days, but I was unable to resume full work days until 1/22/2021. Vision returned to 100%, and nausea resolved, on 1/23/2021. Decreased appetite and fatigue are still an issue as of 1/25/2021.
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| 49 | 2021-01-25 | nausea |
11:00 am feeling pain and could did not have any upper body strenght, severe body aches, nausea, chi...
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11:00 am feeling pain and could did not have any upper body strenght, severe body aches, nausea, chills, second day felt feverish and third day 100.2 fever low grade fever, head arce .
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| 49 | 2021-01-25 | vomiting |
? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat...
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? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat, breathing difficulty, cough, aphasia-pt was not able to express her thoughts or needs, pt felt that her heart was beating slow, vomiting started next day and lasted for 4 days, self treatment immediately by pt- Benadryl 50 mg and albuterol inhaler, later Prednisone course by medical professional symptoms completely resolved after 5 days
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| 49 | 2021-01-25 | nausea, diarrhea |
Injection site pain; joint pain; mild fever; headache; nausea; diarrhea; This is a spontaneous repor...
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Injection site pain; joint pain; mild fever; headache; nausea; diarrhea; This is a spontaneous report from a non-contactable nurse (patient). A 49-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E13248), via an unspecified route of administration on right arm on 11Jan2021 08:30AM at a single dose for COVID-19 immunization at workplace clinic. Medical history included hypertension and obesity. The patient had no known allergies. Concomitant medication included zinc and melatonin in two weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on right arm on 23Dec2020 7:45AM. The patient did not receive other vaccine in four weeks. The patient was not pregnant and was not diagnosed with COVID-19 prior to vaccination. The patient experienced injection site pain, joint pain, mild fever, headache, nausea and diarrhea on 12Jan2021 10:00AM. The events were reported as non-serious. The patient did not receive treatment for the adverse events. The outcome of events was recovering. The patient had not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
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| 49 | 2021-01-25 | nausea |
ON 1/21/21 DEVELOPED NAUSEA, BODY ACHES AND WEAKNESS. SHE CALLED HER DOCTOR, WHO TOLD HER TO WAIT OU...
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ON 1/21/21 DEVELOPED NAUSEA, BODY ACHES AND WEAKNESS. SHE CALLED HER DOCTOR, WHO TOLD HER TO WAIT OUT THE SYMPTOMS OR GO TO THE ER IF THEY GOT WORSE. SHE DID NOT GO TO THE ER.
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| 49 | 2021-01-25 | diarrhea |
migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a con...
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migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142 and expiry date unknown) via unspecified route of administration at the left arm on 08Jan2021 13:45 at single dose for Covid-19 immunization in a hospital. Medical history included vestibular migraines, allergies to ragweed, and allergies to PCN (penicillin). The patient was not pregnant. The patient has no covid prior vaccination. Concomitant medications included amitriptyline hydrochloride (ELAVIL), propranolol hydrochloride (INDERAL), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC), riboflavin (VIT B2), and colecalciferol (D3) and multivitamins; all from unspecified date for unspecified indication. The patient has no other vaccine in four weeks. On day 1 (08Jan2021), the patient experienced sore arm injection site. On day 2 (09Jan2021), the patient experienced diarrhea once. On day 3 (10Jan2021), the patient experienced migraine, vertigo attack. On day 4 (11Jan2021) and 5 (12Jan2021), the patient was still little dizzy. The patient did not receive treatment due to the events. The outcome of the events sore arm injection site, diarrhea, migraine and vertigo was recovering, while dizzy was not recovered.
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| 49 | 2021-01-25 | nausea | severe nausea, headache, muscle aches |
| 49 | 2021-01-26 | diarrhea, nausea | Muscle pain, fatigue, lightheadedness, nausea, diarrhea. Symptoms lasted 6 days. |
| 49 | 2021-01-26 | diarrhea | RASH ON THE SKIN, DIARRHEA |
| 49 | 2021-01-26 | indigestion | Sour stomache headache tired |
| 49 | 2021-01-27 | nausea |
Dizzy; nauseous; a strong taste of metal in my mouth; Extreme gas; This is a spontaneous report from...
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Dizzy; nauseous; a strong taste of metal in my mouth; Extreme gas; This is a spontaneous report from a contactable consumer (patient). This 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 14Jan2021 15:15 for Covid-19 immunisation. The patient medical history was not reported. Concomitant medication included ibuprofen (IBUPROFEN). The patient previously took Augmentin and experienced allergy. On 16Jan2021 07:15, the patient experienced dizzy, nauseous, a strong taste of metal in my mouth, extreme gas. The outcome of the events was unknown. The vaccine was administered at Hospital Facility. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. Information on the Lot/batch number has been requested.
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| 49 | 2021-01-27 | nausea |
Everyday-fatigue 25th Jan 2021-HA @1500, pain at injection site 26th Jan-0930-shaking uncontrollable...
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Everyday-fatigue 25th Jan 2021-HA @1500, pain at injection site 26th Jan-0930-shaking uncontrollable-she states, COLD, body aches, HA, nauseated, sweating, muscular & joint pain 27th Jan-decreased symptoms some, intermittent SOB, chest pain, rt & left sides 28th Jan-SOB-continues, -she has a history of seasonal allergies, Told to go to the ER if her SOB & chest pain gets worse. Took Tylenol & Motrin for the body aches, HA, joint pain and discomforts Can't walk-gets fatigued-even short distances
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| 49 | 2021-01-27 | vomiting, diarrhea |
Feels hot; Fevers/Her temperature is currently 102 degrees; Shakes; Vomiting; Diarrhea; This is a sp...
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Feels hot; Fevers/Her temperature is currently 102 degrees; Shakes; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer reported for self. This 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142) via unspecified route of administration on 12Jan2021 at single dose in left arm for COVID-19 immunization. The patient worked front line in the emergency room (ER). The patient medical history included stage 4 metastatic melanoma from 2013. The patient concomitant medications included nivolumab (OPDIVO) for stage 4 metastatic melanoma. The patient previously received first dose of BNT162B2 (Lot: EJ1685) on 22Dec2020 at single dose for COVID-19 immunization and she didn't feel anything with that dose. The patient experienced shakes, fever, diarrhea, vomiting on 13Jan2021. The patient reported that she had been having shakes and fevers that started at 2:00 AM this morning 13Jan2021. Her temperature is currently 102 degrees on 13Jan2021. It was better but she let herself go 5-6 hours without taking anything. She had been alternating paracetamol (TYLENOL) and ibuprofen (MOTRIN). When it wore off she instantly felt hot and shaky. She also had started having diarrhea and vomiting. The outcome of the events was unknown.
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| 49 | 2021-01-27 | difficulty swallowing |
Injection received in left arm. 1-2 hours later I experienced swelling of throat on the left side, ...
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Injection received in left arm. 1-2 hours later I experienced swelling of throat on the left side, swollen tongue, difficulty swallowing, headache, extreme fatigue
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| 49 | 2021-01-27 | nausea | Nausea, body aches, HA, fatigue, back pain |
| 49 | 2021-01-27 | diarrhea, nausea, vomiting |
Patient received COVID19 vaccine on 1/26/21 (mfg unknown); headache started 1/27/21 at 2pm. Patient...
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Patient received COVID19 vaccine on 1/26/21 (mfg unknown); headache started 1/27/21 at 2pm. Patient had headache and tiredness and diarrhea and body aches after 2nd dose covid vaccine. Symptoms progressed to severe headache associated with N/V, dizziness that started 1/28@0800am. The patient admitted to Emergency Room at Hospital on 1/28/21 and diagnosed with aneurysmal subarachnoid hemorrhage. Patient transferred to Medical Center for care.
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| 49 | 2021-01-28 | difficulty swallowing |
left arm is "double swollen"; broke out in hives; Have troubles trying to swallow; feels like "somet...
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left arm is "double swollen"; broke out in hives; Have troubles trying to swallow; feels like "something is cutting" through her throat; This is a spontaneous report from a non-contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine at 10:30 and then started experiencing "bad side effects" almost 10 hours later. She said her left arm is "double swollen", she broke out in hives, have troubles trying to swallow, and she feels like "something is cutting" through her throat. With this, she wanted to know what temperature should the vaccines be stored in since she noticed that the place where she got the vaccine was "kind of warm". The outcome of the events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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| 49 | 2021-01-31 | decreased appetite |
My arm got sore; Body ache; Low grade fever; I kind of lost my appetite; Extreme fatigue; This is a ...
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My arm got sore; Body ache; Low grade fever; I kind of lost my appetite; Extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283, Expiration Date: 30Apr2021), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. Patient had second Pfizer vaccine last Wednesday morning (13Jan2021) and went to work that day and was fine. Her arm got sore but that was fine and that night around like 10:00 pm, patient got like body ache and low-grade fever and patient was kind of lost appetite and that went on for about a day and a half. But patient had continued extreme fatigue and patient was wondering if that was part of the (sentence incomplete), several days later, it was four days later. Patient just expected it, but it was a little way more. Patient received paracetamol (TYLENOL) as treatment. Outcome of extreme fatigue was unknown. Outcome of other events was resolved after about a day and a half.
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| 49 | 2021-01-31 | nausea |
woke up writhing in pain; had chills so bad my teeth were chattering; had fevers through night; head...
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woke up writhing in pain; had chills so bad my teeth were chattering; had fevers through night; headache 6/10 /My head hurt so bad 10/10; thought I would throw up; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; muscle and bone aches; muscle and bone aches; I was just crying; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3302, intramuscular in the left arm on 18Jan2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 vaccination. Medical history included hyperthyroidism from an unknown date. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included Levothyroxine, Liothyronine, CoQ10, McIntyre Vit D, and Probiotics all from unspecified dates for unspecified indication. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL1284, intramuscular in the left arm on 28Dec2020 at 09:00 as a single dose for COVID-19 vaccination. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On 19Jan2021 at 12:30, the patient experienced writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch. This morning just muscle and bone aches and headache 6/10. The patient did not receive treatment for the events. The clinical outcome of the events writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 49 | 2021-02-01 | decreased appetite, diarrhea |
Full blown flu symptoms. Fever, aches, cough, head conjestion, exhaustion, memory loss, depression, ...
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Full blown flu symptoms. Fever, aches, cough, head conjestion, exhaustion, memory loss, depression, loss of appetite, diarrhea. Missed 5 days of work
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| 49 | 2021-02-03 | diarrhea, retching |
101.9 -highest fever got; body aches; a little bit of joint pain and dry heaving (didn't have anythi...
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101.9 -highest fever got; body aches; a little bit of joint pain and dry heaving (didn't have anything in me); diarrhea. Headache. It lasted until about 6 in the morning and then started getting better. By 4:00 pm on 20th I felt better. Just tired. I called in sick on the 20th. No treatment.
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| 49 | 2021-02-03 | nausea, indigestion |
Around 1325 starting having chest pain and nausea. States pain is similar to heart burn and is const...
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Around 1325 starting having chest pain and nausea. States pain is similar to heart burn and is constant.
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| 49 | 2021-02-03 | diarrhea | Diarrhea, fever, pain at injection site with swelling |
| 49 | 2021-02-03 | difficulty swallowing |
Difficulty swallowing, swollen uvula, rash in ~15-20 minutes Benadryl (self administered), Epinephri...
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Difficulty swallowing, swollen uvula, rash in ~15-20 minutes Benadryl (self administered), Epinephrine & steroids (ED) 4 hours post epinephrine observation Headache, arm pain and lethargy the following day
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| 49 | 2021-02-03 | nausea |
Fatigue, fevers, nausea, body aches, chills, sore throat, swollen lymph nodes. Symptoms started on 1...
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Fatigue, fevers, nausea, body aches, chills, sore throat, swollen lymph nodes. Symptoms started on 1/28/21 and are ongoing.
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| 49 | 2021-02-03 | abdominal pain upper |
Feeling like I have a bad cold. Exhausted, headache, lethargic, stomach ache, no fever. Started the ...
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Feeling like I have a bad cold. Exhausted, headache, lethargic, stomach ache, no fever. Started the morning after I received the first vaccine
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| 49 | 2021-02-03 | nausea |
Headache and nausea the 26th and 27th and 28th. Feeling better the 29th. the 30th I was fine until a...
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Headache and nausea the 26th and 27th and 28th. Feeling better the 29th. the 30th I was fine until about 5 PM and then I felt very ill. Had a fever (highest was 100.8) (which lasted for days) - at least a week that it was 99.9Pand started getting joint pain and muscle aches; nausea; headache. The 30th was a terrible night. I called the DR. that night and they had me come into a COVID test on the 31st. Terrible head pain and earache - amoxicillin for my ears; Dexamethasone - for steriod for the body aches and pains; Norco - or Hydrocodone - I took that as a half a pill a night for 3 or four nights. Z-pack for three or four nights when I started getting chest congestion. I was off work until 15th when I went back to work. I was not 100% but tired. I'm slowly getting better and second dose of the vaccine on the 19th (and I was sick that night - had a high fever - 101.9). Was 24hours of dry heaving; called in sick on the 20th but felt better by the afternoon. Hospital to get the prescription for the ear pain (it might have been on the 5th or 6th of January in the middle of the night).
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| 49 | 2021-02-03 | nausea |
Left lower quadrant pain; Nausea; Fatigue; arm pain; she felt like she caught ' a bug' or 'flu-like ...
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Left lower quadrant pain; Nausea; Fatigue; arm pain; she felt like she caught ' a bug' or 'flu-like symptoms'/experiencing flu-like symptoms; she felt like she caught ' a bug' or 'flu-like symptoms'/experiencing flu-like symptoms; This is a spontaneous report from a contactable healthcare professional (patient herself). A 49-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 at 0.3 ml, single for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced arm pain on 08Jan2021, fatigue on 09Jan2021, nausea on 10Jan2021, left lower quadrant pain on 11Jan2021. The patient said that she felt like she caught "a bug" or "flu-like symptoms" after her first dose of the COVID vaccine. She would like to know if she should get the 2nd dose of the COVID vaccine after experiencing flu-like symptoms after her first dose. Therapeutic measures were taken as a result of nausea and left lower quadrant pain that included ciprofloxacin and metronidazole. Clinical outcome of arm pain was not recovered; for fatigue and nausea was recovering; for left lower quadrant pain was recovered on an unspecified date; while for the other events was unknown.
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| 49 | 2021-02-03 | nausea |
She had chills at 5pm, by 8pm she had heart palpitations, beat red face, nausea and swollen glands i...
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She had chills at 5pm, by 8pm she had heart palpitations, beat red face, nausea and swollen glands in throat. She then went to bed. She woke up around 10pm and felt fatigued but better.
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| 49 | 2021-02-03 | abdominal pain |
Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painf...
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Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painful lymph nodes-to neck and groin and around sides; low grade fever; abdominal pain one day; all days lymph nodes pain /neck lymph node aches/ severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness, especially around the side rib cage and waist area; tenderness especially around the side rib cage and waist area/ severe tender and painful lymph nodes-to neck and groin and around sides; feeling really bad like i want to cry; slight headache; night sweats; rapid heart rate; increased blood pressure; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness to flank area; difficult to turn in bed and lie on right side; Itchiness but no visible rash; first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration at the right arm on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included taking medication for focus (adult adhd?); perimenopausal. She also has known allergies: sulfa; shrimp, strawberry/raspberry flavored foods or candies. The patient was not pregnant at the time of vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for focus, perimenopausal. The patient previously received the first dose of bnt162b2 intramuscularly at the right arm on 28Dec2020 at 2:30 PM at the age of 49 years for COVID-19 immunization (Lot number: EL3249). On 15Jan2021, the patient experienced weakness, fatigue, small breathes like slightly short of breath/ short of breath, body aches, low grade fever, abdominal pain one day, all days lymph nodes pain and tenderness especially around the side rib cage and waist area, more on right side then left, neck lymph node aches, feeling really bad like the patient wanted to cry, slight headache, night sweats. Lymph node pain and tenderness is the worse along with body aches and weakness. Also, on 15Jan2021, patient experienced rapid heart rate, increased blood pressure, severe tender and painful lymph nodes-to neck and groin and around sides, under ribs and tenderness to flank area. Mainly right below right ribs and right waist, right flank painful and difficult to turn in bed and lie on right side. There were also Itchiness but no visible rash. According to the reporter the events started on 15Jan2021 at 1AM. The patient received the first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021. The patient had nasal swab, rapid on18Jan2021 result was negative and nasal swab on 20Jan2021 result was negative. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering except for abdominal pain one day which recovered on 16Jan2021.
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| 49 | 2021-02-04 | nausea | Bilateral Jaw tension Nausea Zofran Improvement of symptoms |
| 49 | 2021-02-04 | decreased appetite, nausea |
Shot received approx. 11:45 am on 2/3/2021. No I?ll effects besides slight injection site pain in ev...
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Shot received approx. 11:45 am on 2/3/2021. No I?ll effects besides slight injection site pain in evening. 6am on 2/4/2021, slight headache, muscle ache, and dizziness. 11am, increased dizziness. 2pm, tiredness, dizziness, increased muscle pain. (2/4/21) 6pm, tiredness, no appetite, fell asleep in chair. 10pm, awoke chilled and with dizziness and went to bed. Woke from sleep with difficulty breathing/catching a breath (2/5/21) and nauseous. 8am, chills, minor breathing issues, elevated temp (98.1) and headache. Slept upright until 1:30pm.
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| 49 | 2021-02-04 | abdominal pain |
This on my 2and vaccine. Had severe abdominal pains literally all day. I did work that day and wh...
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This on my 2and vaccine. Had severe abdominal pains literally all day. I did work that day and when I got home and went to bed around 8PM when I got to for work the next day I felt fine. No more aches
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| 49 | 2021-02-04 | abdominal pain upper | Welt on arm next to site where shot was given. Headache, stomach, achy, tired |
| 49 | 2021-02-05 | nausea | Aches fatigue nausea somewhat disoriented |
| 49 | 2021-02-05 | nausea |
Five minutes after receipt of vaccine, patient c/o dizziness, hot, flush, shaking, nausea. Gave Be...
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Five minutes after receipt of vaccine, patient c/o dizziness, hot, flush, shaking, nausea. Gave Benadryl 25 mg PO @ 1214. 1215 Shaking and other s/s resolved. 1220 All symptoms resolved and decline ambulance nor visit to the hospital. 1237 All s/s resolved and left site.
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| 49 | 2021-02-05 | diarrhea | Headache, brain fog, diarrhea, and exhaustion |
| 49 | 2021-02-05 | diarrhea |
pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt prese...
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pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt presented to my office on 1/25/21 she had confusion, memory loss, labial bp, relative hypotension, bradycardia, severe fatigue, muscle pain and weakness, barely able to rise from a chair or walk, also reported HA, diarrhea, hiccups,decreased O2 sat to a low of 91%-her baseline is 98-100%, she developed a rash after her appointment with me.
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| 49 | 2021-02-06 | nausea |
I got the 2nd vaccination for Pfizer-BioNTech Covid-19 Vaccine EUA and after i have a Fever, chill, ...
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I got the 2nd vaccination for Pfizer-BioNTech Covid-19 Vaccine EUA and after i have a Fever, chill, headache, nauseos and muscle pain where injection is and chest.
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| 49 | 2021-02-07 | retching, nausea | NAUSIA DRY HEAVES FOR 15-20 MIN |
| 49 | 2021-02-09 | nausea |
Chills; Body ache; Headache; Nausea; Fatigue; Keep biting my teeth; This is a Spontaneous report fro...
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Chills; Body ache; Headache; Nausea; Fatigue; Keep biting my teeth; This is a Spontaneous report from a Contactable Other HCP (Patient). A 49-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at 16:45 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 49 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history was none. The patient had no known allergies. Concomitant medications included pravastatin sodium, olmesartan, olmesartan medoxomil, and collagen peptides. On 23Jan2021 at 23:30 the patient experienced chills, body ache, headache, nausea, fatigue and keep biting my teeth. No treatment was received for the events. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. Information about Lot/batch no has been requested.
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| 49 | 2021-02-09 | nausea | Systemic: Nausea, Systemic: Other- Shortness of breath. |
| 49 | 2021-02-09 | diarrhea, vomiting, nausea |
severe nausea and vomiting/diarrhea; severe nausea and vomiting/diarrhea; severe nausea and vomiting...
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severe nausea and vomiting/diarrhea; severe nausea and vomiting/diarrhea; severe nausea and vomiting/diarrhea; Chills; body aches; tired and slept all day; Tingling at fingertips; This is a spontaneous report from a contactable consumer(patient). The 49-year-old female patient(not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot: EL3247), via an unspecified route of administration at left arm on 11Jan2021 16:30 at single dose for covid-19 immunisation. Medical history included hashimotos disease, allergy to penicillin and sulfa, tree nut intolerance. There was no COVID-19 Prior to vaccination. Concomitant medication included levothyroxine sodium (UNITHROID), ethinylestradiol/levonorgestrel (ENPRESSE). There was no other vaccination within 4 weeks prior to the COVID vaccine. On 22Jan2021, 04:00, The patient woke up with severe nausea and vomiting/diarrhea, lasted for the morning, she also experienced chills and body aches. By noon she was fine but tired and slept all day. She also experienced tingling at fingertips. That was all done by night. There was no treatment. Outcome of events was recovered in 22Jan2021. Events were assessed as non-serious. Since the vaccination, the patient had not been tested for COVID-19.
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| 49 | 2021-02-10 | nausea, abdominal pain, diarrhea |
First week had headache, nausea, dizziness with room spinning. Starting the second week had a Crohn'...
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First week had headache, nausea, dizziness with room spinning. Starting the second week had a Crohn's flare with abdominal pain and diarrhea, which has continued. Hospitalized due to dehydrating and low potassium, given steroids, fluids, and potassium supplement.
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| 49 | 2021-02-16 | vomiting |
Soon after shot my lips tingled and I got really tired so I knew I was having a slight reaction. Th...
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Soon after shot my lips tingled and I got really tired so I knew I was having a slight reaction. That was it until later that night I started getting a really bad headache/migraine. I started taking Tylenol but that didn't help much. I got chills and I'm sure a slight fever because I was sweating. I started throwing up also.. After taking Tylenol every 4 hours my headache finally went away and I started to feel better. This was around 2:30 pm the following day. I would say my symptoms lasted for about 22 to 24 hours.
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| 49 | 2021-02-22 | diarrhea |
Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic S...
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Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic System
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| 49 | 2021-02-22 | nausea |
hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis;...
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hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis; This is a spontaneous report from a contactable physician via FDA. A 49-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in the arm on 17Dec2020 at 13:30 at 0.3 ml, single dose for covid-19 immunization. Medical history included ongoing essential hypertension, ongoing protein c deficiency, ongoing lumbosacral radiculopathy, ongoing type 2 diabetes mellitus, ongoing pulmonary embolism, Strep pharyngitis from 29Nov2020 and resolved at the time of vaccination, serious allergic reaction, allergy to iodonated contrast media and Cardiac Arrest after IV contrast. Concomitant medication included apixaban (unknown manufacturer) for Protein C Deficiency, metformin hydrochloride (unknown manufacturer) for Type 2 Diabetes, chlorthalidone (unknown manufacturer) for hypertension, metoprolol (unknown manufacturer), clonidine hydrochloride (unknown manufacturer) for hypertension, atorvastatin (unknown manufacturer), magnesium oxide heavy;tocopheryl acetate (unknown manufacturer), tramadol hydrochloride (unknown manufacturer), diphenhydramine hcl (unknown manufacturer), epinephrine bitartrate (unknown manufacturer) for serious allergic reaction and anaphylaxis. On 17Dec2020 at 13:48, approximately 13min after vaccination while in observation the patient experienced hives, facial swelling, throat swelling/itching, and nausea. Patient was immediately taken to Emergency Department where epinephrine was given 1M in the left thigh followed by 125mg IV solumedrol, 50mg IV benadryl, 1000mL NS, and 20mg IV famotidine. Hemodynamically stable throughout ED course. The events were considered serious as per hospitalization. Medical Tests and Laboratory results related to the adverse event included: CRP: 11.0, Glucose-182, BRN-29, INR-1.1, Remained of CMP and CBC were WNL. The physician stated that anaphylactic reaction onset 6min after vaccination symptoms improved - 20min after epipen administration, Resolved 60 min later. The signs and symptoms of anaphylactic reaction included Diffuse rash, Itching, throat/lip swelling, shortness of breath, cough, BP 128/72, Spon-97% HR-71. The patient rushed to ED from vaccination PoD. Received EpiPen approximately 8 min post vaccination. Then received steroid, antihistamines, IVF. Sx improved in 20 min resolved 60 min. The patient was not hospitalized and not admitted to an intensive care unit for anaphylactic reaction. The physician stated that multiorgan involvement included respiratory, dermatological/mucosal. Also reported as Respiratory: Yes; Upper airway swelling: Yes; Respiratory distress: Yes; Tachypnoea: Yes; Dry cough: Yes; Difficulty breathing (without wheeze or stridor):Yes; Dermatological/Mucosal: Yes; Generalized urticarial: Yes; Angioedema (not hereditary): Yes; Generalized pruritus with skin rash: Yes. The following laboratory tests or diagnostic studies performed included Hematology on 17Dec2020 showed: results with units, if applicable: 8/13/299/41; Clinical chemistry on 17Dec2020 showed: results with units, if applicable: 137,103,29/36,22,07 (Less than sign) 182; CRP on 17Dec2020 showed: results with units, if applicable: 11.0. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient had anaphylaxis on 17Dec2020 at 13:36. The patient was not deceased and received treatment. Treated in emergency room/ epinephrine IM IV steroids, antihistamines, IV fluids. The physician considered the Pfizer product had a causal effect to the adverse event. The outcome of the event anaphylactic reaction/ anaphylaxis was recovered on 17Dec2020, while other events were recovered on 17Dec2020 at 13:48. Information on the lot/batch number has been requested. Follow-up (08Feb2021): New information received from the contactable Physician included: additional medical history and lab data, concomitant medications details, suspect drug information (lot number, dosage regimen details), event information (new event "anaphylactic reaction/ Anaphylaxis") and other clinical courses.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events anaphylactic reaction/Anaphylaxis urticaria, swelling face, pharyngeal swelling, throat irritation and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-02-23 | nausea, vomiting | Body aches, chills, migraine, 102 fever, nausea, vomiting. |
| 49 | 2021-02-24 | decreased appetite |
Sun 2/21 - fever (101.1), site of injection soreness, body aches, joint aches, headache, fatigue, lo...
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Sun 2/21 - fever (101.1), site of injection soreness, body aches, joint aches, headache, fatigue, loss of appetite. Mon 2/22 - same as Sunday 2/21 but fever came down to 100.1 and symptoms were generally milder Tues 2/23 - better in general and fever broke during early hours of morning. Most symptoms still present but milder Wed 2/24 11:30am mild breathing difficulty began and at 1 pm inhaler was used. Breathing difficulty subsided (but not fully restored)until @7pm and 1st nebulizer treatment was done. Breathing difficulty subsided (but not fully restored) until @10:45pm and 2nd nebulizer treatment was done. Hands were noticed to have purple coloring prior this nebulizer treatment. Thurs 2/25 7:00am breathing was labored and became difficult by 8:30am and was taken to emergency room for evaluation and treatment.
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| 49 | 2021-02-25 | vomiting, nausea | Fatigue, chills, headache, shortness of breath, nausea, vomiting for 2 weeks duration |
| 49 | 2021-02-25 | nausea, abdominal discomfort |
No side effects with 1st dosage. within 8 hours of 2nd dose side effects included: rapid heart rate...
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No side effects with 1st dosage. within 8 hours of 2nd dose side effects included: rapid heart rate, insomnia, body pain, joint pain, lower back pain, severe chills, upset stomach, nausea, headache. Within 36 hours, most of the side effects were gone, except headache. 3 days later - still have headache, and flush feeling all over body with mild sore throat (as of 2/26/21 @ 11:27 a.m.)
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| 49 | 2021-02-25 | nausea, diarrhea, vomiting |
Received COVID vaccine 1 on 1/13 and COVID vaccine #2 2/1. 49 y/o previously healthy female who had...
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Received COVID vaccine 1 on 1/13 and COVID vaccine #2 2/1. 49 y/o previously healthy female who had a COVID 19 exposure ~ 1/3. The person she was exposed to tested positive 1/6 (daughter had a fever and cough). On 1/11 the patient received the 1st dose of the Pfizer vaccine. 12-24 hours after the Pfizer vaccine she developed fevers, malaise, myalgias that lasted 2-3 days (Called off work). She then returned to a normal state of health. On 2/1 she received the second dose of the vaccine. On 2/6 she developed right pleuritic chest pain so went to an urgent care. COVID 19 PCR was positive and CXR unremarkable. She was told to take naproxen and her pleuritic chest pain slowly improved. On 2/8 she started to have general malaise followed by nausea. On 2/11 she developed increased nausea and vomiting followed by diarrhea-eventually that day she had a near syncopal episode prompting her presentation to the hospital. Seen at an outside hospital between 2/11-2/12. CT abd/pelvis showed patchy ground glass opacities at the base of the lungs and she was noted to have diffuse mural thickening. There was concern for possible cholecystitis so a perc cholecystostomy tube was placed. Ultimately she developed significant hypoxic respiratory failure and had to be intubated.She was transferred to another hospital on 2/12. Initially she was started on treatment with dexamethasone but continued to clinically get worse. Also on empiric antibiotics.
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| 49 | 2021-02-26 | diarrhea |
Mild fever, tiredness and loose bowel which cleared up after 12 hours. Vaccine also seemed to provok...
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Mild fever, tiredness and loose bowel which cleared up after 12 hours. Vaccine also seemed to provoke an MS-related response with pain in back, leg spasms and difficulty walking. Symptoms began to clear about 24 hours after onset (36 hours after vaccine injection). First vaccine was tolerated well with only mild and normal side effects (mild cough, soreness at injection site, etc.).
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| 49 | 2021-02-26 | nausea |
Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: she mentioned that thi...
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Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: she mentioned that this is a common reaction after vaccinations. she felt hot, sweat, nausea symptoms. nurse practioner on duty monitored her while she waited in the wait area for abour 20mins. she was feeling fine before she left. Rph called her about an hour and half later and she was back to normal.
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| 49 | 2021-02-26 | diarrhea |
came to the vaccination appointment with no current illness or cough. Within less than 5 minutes af...
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came to the vaccination appointment with no current illness or cough. Within less than 5 minutes after the injection started with a cough that is similar to asthma attack onset. As talking with the nursing staff on site after waving them over I began to get worse very quickly. Within minutes I heard one of the staff say "she's crashing, move it". At that point I could not breathe, audible wheezing, shortness of breath, throat was closing, entire body felt like it was on fire, extreme itching on back (especially upper back), shaking/convulsing, incoherent. Paramedic staff was put into place and i was ambulanced to the hospital across the street from the vaccination site. Everything is a whirlwind at this point and treatment from what I can remember was albuterol svn, atrovent svn, use of cpap, epipen administration in the parking lot, benadryl via iv, solumedril, oxygen and pepcid. Once arrived at E.R. I was aggressively treated. Once stabalized began to wheen off the oxygen onto room air. I am a rare asthmatic and my oxygen sats usually do not drop, although I am in distress. At one point I heard oxygen sats were at 96, which is low for me. I was discharged from the hospital to my husband's care. In the next days now I am expriencing fever (100), itching, red rashy skin, severe headaches, joint pain, body ache, diarehha and extreme fatigue
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| 49 | 2021-02-27 | nausea, abdominal discomfort | Fever 100, chills, hot flashes, nausea, splitting headache, low ringing in ears, upset stomach |
| 49 | 2021-02-27 | nausea | Headache, eyes sensitive to the light, nausea, soar arm. |
| 49 | 2021-02-28 | nausea |
Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120...
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Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120's bpm), nausea, severe fatigue, severe soreness at injection site (but mild swelling, mild itching). Starting from 3:30 am on 02/21/21 until about 3 pm on 02/22/21. Milder headache and fatigue throughout rest of that week. Back to normal now.
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| 49 | 2021-02-28 | decreased appetite |
The side effects after the first of the two vaccinations (01/23/21) resulted in the side effects sta...
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The side effects after the first of the two vaccinations (01/23/21) resulted in the side effects starting same night and resolving by 01/25/21 of headache, fatigue and localized soreness at vaccine injection site. The side effects from tge 2nd vaccination administered on 02/13/21 resulted in the side effects beginning later the same night of moderate site soreness, severe fatigue, headache, feeling hot and cold, loss of appetite and pain in muscles. All of the side effects resolved by 02/18/21 except the fever and chills which has happened every night since the second vaccination and had not been experienced prior to tge vaccination.
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| 49 | 2021-03-03 | nausea | Dizzy, anxious, tachycardia, nausea |
| 49 | 2021-03-03 | decreased appetite |
Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appet...
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Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appetite; stuffy nose; sneezing; drowsiness; confusion; agitation; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9269) via unspecified route on left arm single dose for COVID-19 immunization on 01Feb2021, 04:00 PM at 49-year-old. Medical history included: osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID-19, known allergies. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK923) left arm for COVID-19 immunization on14Jan2021, 01:30 PM at 49-year-old; had body aches, fever, sore arm and skin ach. No other vaccine received in four weeks. On 02Feb2021, 02:00 AM, the patient had intense pain, intense joint pain, intense eye pain, intense headache, loss of balance, loss of appetite, stuffy nose, sneezing, drowsiness, confusion, agitation. Outcome of the events was not resolved.
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| 49 | 2021-03-04 | nausea | Headaches so bad that I feel like I'm going to throw up. Happens every day. Sometimes twice a day. |
| 49 | 2021-03-07 | diarrhea, vomiting, nausea |
Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a...
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Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a full dinner, went to bed at 10:00. Woke at 4:00 am feeling very achy. Went to kitchen for ibuprofen, took two. Started feeling very nauseated. Went to master bathroom to urinate, and started feeling like I was going to faint. Tried to make it three steps to my small sofa outside bathroom door. That?s the last thing I remember. My husband heard me fall. I had fallen chin first on hardwood floor. He found me lying in a pool of blood. Before going to ER in the next 15 minutes, i had an extreme bout of diarrhea. At ER, I learned that I had Broken both my condyals in jaw and fractured lower mandible. At ER and hospital on 2/2, threw up multiple (about 7-8) times, even with anti-nausea drugs in IV. Doctor put an anti-nausea patch behind my ear but not sure if it helped. Had surgery to set it on 2/3/21.
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| 49 | 2021-03-08 | nausea, decreased appetite |
hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; he...
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hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-03-22 | nausea, vomiting | Fever, chills, nausea, vomiting, severe headache, neck and body pain |
| 49 | 2021-03-29 | nausea |
Extreme fatigue; nausea; muscles aching; muscle twitching; sweating; This is a spontaneous report fr...
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Extreme fatigue; nausea; muscles aching; muscle twitching; sweating; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Mar2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included myasthenia gravis, undiagnosed autoimmune disorder, non-alcoholic fatty liver disease, hypertensive heart disease and allergy to mushrooms. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 12:45, the patient experienced extreme fatigue, nausea, muscles aching, muscle twitching and sweating. No treatment was given for the events. The outcome of the events extreme fatigue, nausea, muscles aching, muscle twitching, and sweating were not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 49 | 2021-03-30 | vomiting, diarrhea, nausea |
fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, naus...
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fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; Dilated cardiomyopathy; fever; chills; vomiting; severely low potassium; fluid build up around her heart and lungs; fluid build up around her heart and lungs; This is a spontaneous report from a contactable consumer (patient's husband). A 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location; Arm) on 22Jan2021 13:00 as SINGLE DOSE for COVID-19 immunisation. Patient's medical history was not reported. Concomitant medication included biotin from an unspecified date and unknown if ongoing. The patient previously took 1st dose of the Pfizer COVID Vaccine on 29Dec2020 (around 10:00 am to 12:00 pm at a hospital) and had the usual side effects of a little bit of nausea, developed a dry cough, some fatigue, and diarrhea and that kind of stuff. The reporter called about the Pfizer COVID vaccine and was calling on behalf of his wife who was the patient. Reporter stated that before the Pfizer COVID vaccine, patient used to walk the dogs 6 miles a very fast pace and had no problem, then she got her 1st dose of the Pfizer COVID vaccine on 29Dec2020 and had the usual side effects of a little bit of nausea, developed a dry cough, some fatigue, and diarrhea and that kind of stuff. The reporter stated that after the 1st dose of the Pfizer COVID vaccine, the symptoms she reported have worsened and the cough, fatigue, nausea, and diarrhea began immediately after the 1st dose of the vaccine where the cough started a week or so after the 1st dose and then after the 2nd dose, the cough never went away and got worse and worse and worse. Reporter stated the fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse. Reporter mentioned that for the cough after the first dose of the Pfizer COVID vaccine, it was still there but was occasional and was not too bad but when the patient had the 2nd dose on 22Jan2021 and was knocked on her butt for about three days; also stated that the patient had fever, chills, diarrhea, vomiting, nausea and the works and had all the symptoms. It was also reported that the patient was very sick for 3-4 days with same symptoms. Reporter mentioned that fatigue was getting worse and the cough never went away and always had the dry cough which was getting worse and worse and worse with any activity and was a dry cough and she never had any phlegm. Reporter also stated the patient got to where she did less and less activity and was worse and the dry cough was worse with nothing coming up. It was reported that the patient sought treatment for everything she believed last week on Monday but was unsure of the dates. Monday of last week, patient went to the emergency room in a hospital and was told that they thought that the patient had an enlarged heart and severely low potassium and the patient was put on an IV drip of potassium because she could not tolerate the oral potassium and threw up the oral potassium so she was put on two bags of IV potassium. On an unknown date, it was reported that patient started having pain in her chest from the IV drip of potassium but she was released from the emergency room and the 2nd day of last week which was the next day, patient went back to the emergency room because she was having issues and everything was getting worse. Reporter also stated that the 2nd of last week, the patient collapsed and an ambulance came and got her on Tuesday of last week though reporter was unsure of the dates. Reporter also mentioned that patient went to a hospital and had severe chest pain and collapsed pressure on her chest. Reporter stated that the patient at that time had the dry cough and stuff and the hospital told the patient that the patient had fluid build up around her heart and lungs which was maybe due to the treatment from the IV potassium and was told she has a weakened heart. It was reported that with a weakened heart, the heart can't process fluid around the lungs and the heart and it puts pressure on heart supposedly. It was reported that on Wednesday last week, the patient went to the emergency room for the 3rd day in a row and already had an appointment with the HCP which was an appointment with her new primary Nurse Practitioner for the first appointment and she confirmed that the patient had fluid on the lungs when she saw the patient. Reporter stated that the nurse practitioner could not admit the patient because the hospital she admits too was full so she sent the patient to a hospital emergency room where they did all the tests and everything confirmed what they said and they transferred the patient to another hospital where the patient stayed in the hospital a total of three days and was diagnosed with cardiomyopathy and they started treatment on the patient. The patient was started on Entresto later on and tomorrow there was a follow up visit with her primary HCP and they have to follow up because the patient was released from the hospital and was very weak and she has to wear a lifevest because she is a heart patient and has a weak heart. It was reported that patient is going to be taking medications and stuff and will go see the HCP and they gave her beta blockers and other stuff and she will follow up with the HCP. It was reported that any of the medications including the beta blockers the patient was taking, reporter has no names of the medications, dosages or lot numbers or other information to provide at this time and stated that the patient was treated with those medications in the hospital and that was the hospital in another city and state. Reporter mentioned that it was last week when the patient collapsed while trying to walk across the yard and she was diagnosed with dilated cardiomyopathy where part of the heart shrunk which is the expelling chamber of the heart and the HCP stated where a normal 20-30 year old would have heart function of 55, the patient had an output of 15. Reporter stated that the HCP said that stroke, disease or things like that can cause cardiomyopathy and there are various things that can cause it but they can't diagnose what caused this in the patient because she has not had various things and the only she had was the Pfizer COVID shots that hit her very hard and she just turned age 50. Reporter stated that the patient was age 49 at the time she began experiencing the symptoms that were reported and just turned age 50. Reporter clarified to state the potassium drip the patient had was not at this hospital but was at another hospital. Reporter stated he has no lot numbers, expiry dates or NDC numbers to provide as he does not have the patient card for the Pfizer COVID Vaccine that the patient received and that paperwork is with the patient who is staying at her sister's house so the sister can help monitor the patient. Reporter also mentioned that patient was not taking medications at the time she received the Pfizer COVID Vaccine at that time but was taking over the counter Biotin and states he has no lot, expiry date or UPC to provide. Reporter mentioned that patient has no family history of heart conditions but he thinks the patient's mother is diabetic but she is the only who is diabetic and there is no other history he is aware of. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 49 | 2021-04-01 | nausea |
Bleeding during bowel movements; Nausea; fever; This is a spontaneous report from a contactable othe...
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Bleeding during bowel movements; Nausea; fever; This is a spontaneous report from a contactable other health professional (HCP). A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration administered in left arm on 05Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history included COVID-19 which was prior to vaccination. There were no concomitant medications. On 08Mar2021, the patient experienced bleeding during bowel movements, nausea and fever. The patient was hospitalized for 4 days. The patient had colonoscopy as treatment for the event. The outcome of the events was recovering. The patient was not tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported nausea and fever and the administration of the COVID19 vaccine, BNT162B2, based on the reasonable temporal association and the known safety profile of the suspect. Conversely, the reported bleeding during bowel movements is unlikely related to the suspect vaccine. More information on the patient's medical history, concurrent medical conditions would be helpful for the Company to provide a more meaningful causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 49 | 2021-04-06 | nausea, difficulty swallowing |
face felt like plastic; Acute pain in base/spine of neck; dizziness; difficulty breathing & swallowi...
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face felt like plastic; Acute pain in base/spine of neck; dizziness; difficulty breathing & swallowing; difficulty breathing & swallowing; nausea; metallic taste in mouth; double vision; This is a spontaneous report from a contactable consumer. A 49-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm on 18Mar2021 at 08:15 (Batch/Lot Number: EP7534) as a single dose at the age of 49, for Covid-19 immunisation. Medical history included juvenile- als, and a sulfa allergy. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 18Mar2021, after use of product patient developed Acute pain in base/spine of neck, dizziness, difficulty breathing & swallowing, nausea, metallic taste in mouth, face felt like plastic, double vision. The patient was not hospitalized nor was treatment received for the events. The outcome of the events was recovered. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19. Additional Information has been requested.
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| 49 | 2021-04-12 | vomiting |
pneumonia; congestion; Vomiting; Chills; cough; exhaustion; headache; ears burning; lung pain; short...
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pneumonia; congestion; Vomiting; Chills; cough; exhaustion; headache; ears burning; lung pain; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration, administered in the left arm on 27Mar2021 at 09:45 as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. The patient did not have COVID prior to the vaccination. Concomitant medication included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported. On 28Mar2021 at 12:30, the patient experienced vomiting, chills, cough, exhaustion, headache, ears burning, lung pain, shortness of breath and congestion. The patient went to doctor on 30Mar2021 and apparently, she has pneumonia. The patient also mentioned that she barely had a stuffy nose before taking the vaccine. The patient has a rapid response nasal swab COVID test on 29Mar2021 with a negative result and a PCR nasal swab COVID test also on 29Mar2021 with an unknown result. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. Information on the batch/lot number has been requested.
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| 49 | 2021-04-13 | difficulty swallowing, nausea |
Anaphylactic Reation. everything swelled and rash appeared, couldn't swallow, throat constricting. ...
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Anaphylactic Reation. everything swelled and rash appeared, couldn't swallow, throat constricting. Epinephrine injection, Racepinephrine, diphenhydramine methlprednisolone, famotidine Day after feel like run over by a truck and nausea, feel sick, headache, joint pain not sure how long everything will last or if more will appear
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| 49 | 2021-04-20 | nausea, diarrhea, vomiting |
microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coag...
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microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with coagulopathy; thrombotic microangiopathy; jaundice; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable physician. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 29Mar2021 13:45 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation. Patient was not pregnant. The COVID-19 vaccine was administered at Doctor's office/urgent care. Medical history included Metastatic breast cancer. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant Therapy included Clinical trial oral drug - ARV-471 on 22Mar2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient presented to the hospital on 05Apr2021 complaint of (c/o) 1 week of jaundice, nausea, vomiting, and diarrhea, which started on an unknown date in Mar2021, and on 05Apr2021 found to have evidence of microangiopathic hemolytic anemia, thrombocytopenia, and severe hyperbilirubinemia/cholestasis with coagulopathy. Work-up revealed like thrombotic microangiopathy although etiology unclear. ADAMTS13 level 29 with no inhibitor not suggestive of Thrombotic thrombocytopenic purpura (TTP). Patient eventually died of this acute presentation. She also had a history of metastatic breast cancer and had also just started taking a phase 1/2 oral clinical trial drug ARV-471 on 22Mar2021. Unclear if the drug, COVID vaccine, or breast cancer may have contributed to current illness. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Patient died. Patient hospitalized for 5 days. Date of Death was on 09Apr2021. Death cause: Death certificate stated metastatic breast cancer. No autopsy performed. Therapeutic measures were taken as a result of events included plasmapheresis, steroids, antibiotics. The patient underwent lab tests and procedures which included Nasal Swab: negative on 05Apr2021. The outcome of the events was fatal.; Sender's Comments: Based on temporal association and the limited information available, the causal association between BNT162B2 vaccine and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: severe hyperbilirubinemia/cholestasis with coagulopathy; jaundice; nausea; vomiting; diarrhea; microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with co
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| 49 | 2021-04-20 | vomiting |
my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; m...
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my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; I was afraid I was having a heart attack; Initial hyperactivity; tiredness; chest pains; urge to vomit; body aches all over; This is a spontaneous report received from a contactable consumer (patient herself). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration in left arm on 01Apr2021 at 16:00 (at the age of 49-year-old) as a single dose for COVID-19 immunization. The patient's medical history included issues with anemia in the past and known allergies: Tree nuts was all that I am aware of (allergies to medications, food, or other products: Tree nuts was all that I am aware of). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccine within four weeks of vaccination. The patient did not receive other medications within two weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. No COVID prior vaccination. The patient was not tested for COVID post vaccination. It was reported that the, initial hyperactivity on 04Apr2021 (patient think it was the anticipation of the shot), followed by tiredness that evening on 04Apr2021, Friday, Saturday, and Sunday. With the exception of having lunch with a friend on Saturday and stopping by to check on her mom, patient stayed home all weekend because she was feeling very tired. Late Sunday night after going to bed she awoke with chest pains and the urge to vomit on 04Apr2021. Patient was up and down vomiting for several hours and began to experience body aches all over on 04Apr2021. At one point she was afraid she was having a heart attack on 04Apr2021. On Monday morning and throughout the day she was still experiencing body aches and stayed home from the office. Patient slept propped up on the living room sofa Monday night because lying down made her body aches worse. Today, Tuesday 06Apr2021, her right leg was still bothering her, it feels a little bloated, so she was walking slower than usual. Otherwise she feel normal. The events were considered as serious (life threatening, hospitalization) by the consumer. No treatment medications were received for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 49 | 2021-04-21 | nausea |
Extreme non stop aching. Nausea Temperature that ranged from 99 to 103 Chills Headache Very Sore t...
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Extreme non stop aching. Nausea Temperature that ranged from 99 to 103 Chills Headache Very Sore throat Burning when taking a deep breath
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| 49 | 2021-04-24 | nausea |
Before the Bell's Palsy diagnosis she felt like she was getting a cold; dry eye and eye watering; pa...
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Before the Bell's Palsy diagnosis she felt like she was getting a cold; dry eye and eye watering; pain in her feet; dry eye and eye watering; Bell's palsy; Legs went numb; Feet burning; Arms went numb; Nausea; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 11:45 (Batch/Lot Number: ERG213) as a single dose for covid-19 immunisation. The patient's medical history included ongoing systemic lupus erythematosus diagnosed 17 years ago. The patient's concomitant medications were not reported. On 30Mar2021, the patient experienced headache and nausea, arms went numb on 31Mar2021, legs went numb and feet burning on 01Apr2021. On 05Apr2021, the patient was diagnosed with Bell's palsy. It was also reported that before the bell's palsy diagnosis she felt like she was getting a cold. It was further reported that on the first day the patient had a headache and nausea. The second day her legs went numb for 3 days, on 05Apr2021 she got Bell's Palsy. Patient cannot talk, symptoms were not treated in any way. Patient had numbness in her arms first and then it went to her legs. She later clarified her arms and legs are still numb. The headache started soon as she got the vaccine. Her nausea started 2 hours after the vaccine and lasted 8 hours. Her legs still bothering her. She still has pain in her feet. Before the Bell's Palsy diagnosis she felt like she was getting a cold. She had a headache on the right side of the face. Her tongue was numb 3 days ago. She can't close her eye all the way, it was causing headache, dry eye and eye watering. It was going into her nose. Her lip was moving, she cannot talk. She went to urgent care last night after her daughter asked why she was winking. Her lip was sagging and thought it was a stroke. They said the Bells Palsy was definitely from the vaccine. The outcome of the event nausea was recovered on 30Mar2021, Bell's Palsy legs went numb, arms went numb, feet burning was not recovered and unknown outcome for the event before the Bell's Palsy diagnosis she felt like she was getting a cold.
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| 49 | 2021-04-28 | abdominal pain, vomiting |
This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old fem...
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This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 49 years old at other facility type. The patient is not pregnant at time of vaccination. Medical history included allergies to Rosemary from an unknown date. No other vaccine in four weeks were noted. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC); propranolol hydrochloride (INDERAL); lorazepam (ATIVAN); hctz; quetiapine fumarate (SEROQUEL); gabapentin taken for an unspecified indication, start and stop date were not reported. The patient previously took macrobid [nitrofurantoin] and experienced allergies. The patient previously received the first dose of BNT162B2 (Lot number: ER8727) on 17Mar2021 13:00 (left arm) for COVID-19 immunisation. On 10 Apr2021, the patient experienced Itchy palms (reported as within hours), tachycardia, tightness in chest, difficulty breathing, tingling tongue and fingers, vomiting, confusion, dizzy, fainting, abdominal pain, severe pain everywhere, too fatigued to move. Patient tried to call ambulance but could not get phone or unlock the door. She stated she tried from 1 AM to 07:30 AM. After 07:30 AM she had expected effects of fever as well as fatigue and pain. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was not given. Outcome of the events was recovered on an unspecified date.
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| 49 | 2021-04-28 | diarrhea, nausea, abdominal pain upper |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Chills; Fatigue; stomach...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Chills; Fatigue; stomach pains; nausea; diarrhea; migraine; dizziness; body aches; faint; This is a spontaneous report from a contactable consumer reporting for self. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 31Mar2021 10:00 (Batch/Lot number was not reported) at the age of 49 years old, as single dose for covid-19 immunisation. Medical history included allergies to penicillin, codeine, Bactrim, sulfa drugs. Concomitant medications included alprazolam; sumatriptan succinate (IMITREX); amitriptyline. The patient experienced Chills, Fatigue, stomach pains, nausea, diarrhea, migraine, body aches, dizziness, faint from 01Apr2021. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient had Nasal Swab on 07Apr2021 with negative result, and on 13Apr2021 with Positive result. Outcome of event COVID-19 virus test positive was unknown, of other events was not recovered. Information about lot/batch number has been requested.
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| 50 | 2021-01-03 | nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to ...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to experience whole body chills, teeth chattering, and extreme fatigue. I took Ibuprofen and went to sleep. I experienced chills until approx 3 AM. My watch alerted my heart rate rose above 120 bpm three separate times during the night in the 1, 2 and 3:00 hours. Upon review of the summary it appears to have been sustained at just over 120 for that entire time. I awoke at noon, with a temp of approx 99.5 F, I felt extreme fatigue and a sense of cold but body was warm to touch and I was very sweaty this entire time. I slept most of the day and at 5 pm awoke with a temp of 102.4F. I contacted my physician who directed me to use tylenol and Benadryl. I took a dose at 5 pm, anther at 9 PM. Upon waking the next morning I was afebrile. At that time I felt slightly dizzy and lightheaded but also dehydrated. Forcing fluids relieved symptoms. I experienced a very mild headache and very mild queasiness as well.
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| 50 | 2021-01-03 | vomiting |
Received the injection on Wednesday afternoon. I woke up around 3am with an excruciating headache, s...
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Received the injection on Wednesday afternoon. I woke up around 3am with an excruciating headache, started vomiting around 6am and continued until 7:30pm. The headache continued and as of this morning 1/4 the headache is still there and my stomach is not settled completely.
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| 50 | 2021-01-04 | nausea | Patient became anxious, nauseated and very fussy 20 minutes after injection. |
| 50 | 2021-01-04 | nausea |
Sometimes her headaches are migraines; Chills; Fever; Cough; Really lazy; Body aches; Headache; Naus...
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Sometimes her headaches are migraines; Chills; Fever; Cough; Really lazy; Body aches; Headache; Nausea; This is a spontaneous report from a contactable Registered nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: E10140), via an unspecified route of administration on 23Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included ongoing Diabetic for at least 7 years, ongoing hit in the head (She was a psych nurse and was hit in the head at work maybe a month to two months ago in 2020. She did have headaches from that incident). There were no concomitant medications. The patient experienced headache on 23Dec2020, fever on 24Dec2020 14:30, nausea on 23Dec2020, cough on 24Dec2020, really lazy on 24Dec2020, chills on 24Dec2020 14:30, body aches on 24Dec2020, sometimes her headaches were migraines on an unspecified date. Specifically, it was reported that when she first got the vaccine, she didn't have anything but a headache and a little bit of nausea. She had worked the night before and didn't sleep before the shot. So maybe that had a part in it. She was a diabetic. It was fine, and no big deal that night. Then, the next day on 24Dec2020 at 2:30 pm she woke up and she was freezing and couldn't get warm. She had chills and a fever of 102.1 on 24Dec2020. She took Tylenol, and it came down to 101 on an unspecified date in Dec2020. All weekend long, she has had a fever. It has been controlled by Tylenol. She had chills so bad she had to use her heated blanket. She has had a cough. She has been really lazy. She has had chills and body aches. She has had nausea here and there. She has had a headache. She received the vaccine on the 23Dec2020, which was Wednesday. She had to stay 15 minutes after. That is when she developed the headache and nausea. Sometimes her headaches were migraines. She developed the fever on 24Dec2020 14:30. Or noticed the fever when she woke up. Her fever was 101.2 this morning on 28Dec2020. Within the 15 minutes of getting the vaccine, she developed the nausea. It has gotten better. Her body aches are getting better. She still has chills when she is running a fever. She has gotten better overall. Thursday (24Dec2020), Friday (25Dec2020), and Saturday (26Dec2020) it was awful. Sunday (27Dec2020) the symptoms lightened up. Today (28Dec2020) she was better. She still had a headache and fever this morning, but nothing like she had been feeling. She felt like dying those days. She was a Psych nurse, and she got hit in the head. So she did get headaches from that incident. They are about the same as these headaches so she didn't know if it was related. It just went along with the flu like symptoms. But sometimes these headaches were migraines. Therapeutic measures were taken as a result of fever and chills. The outcome of the events headache, chills was not recovered. The outcome of the event really lazy was recovered on 27Dec2020. The outcome of the events fever, nausea, cough, body aches was recovering. The outcome of the event migraines was unknown.
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| 50 | 2021-01-04 | decreased appetite |
body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to ex...
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body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to explain it very well; change of sense of taste; loss of taste; body rash on upper torso only described as "not bad" and "not itchy" or bothersome; low grade fever 100.3; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left upper arm, on 21Dec2020 06:30 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient's weight was 67.13 kg and height was 173 cm. The patient's medical history included nausea and flu like symptoms. Concomitant medications included omeprazole(PROTONIX) from Dec2020 at 40mg once a day for nausea. The patient stated that a week before she received the vaccine she had flu like symptoms and she was tested for COVID-19 and the test result was negative in Dec2020. The patient experienced low grade fever 100.3 which started in the evening of the vaccine(21Dec2020) and she took Tylenol and went to sleep and the next day felt better, which resolved by the next day(22Dec2020). The patient experienced body aches on an unknown date, body rash on upper torso only described as "not bad" and "not itchy" or bothersome which started on 21Dec2020(a few hours after receiving vaccine) and resolved on 23Dec2020. The patient experienced change of sense of taste, "everything tastes metallic and it's kind of hard to explain it very well" on 24Dec2020. The patient experienced loss of tastewhich started on either 23Dec2020 or 24Dec2020. She was starting to be able to taste. She has anything it is bland. She can taste some saltiness. That started coming back on approximately Saturday, 26Dec2020. The patient experienced decreased appetite, "cotton mouth" on an unknown date. The outcome of the events "low grade fever 100.3", "body rash on upper torso only described as "not bad" and "not itchy" or bothersome", "loss of taste" was recovered and of other events was unknown.
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| 50 | 2021-01-04 | decreased appetite, nausea |
headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, som...
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headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, some chest pain, feel woosy, felt confussed right after vaccine,
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| 50 | 2021-01-05 | nausea |
Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began...
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Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began after 10 hours - reduced pain after 24 hours, but still present Headache - began after 8 hours - still present Cough - began after 8 hours - still present Sore Throat - began after 8 hours - still present Shaking hands - began next morning - still present
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| 50 | 2021-01-06 | nausea | Nausea, Chills, Achiness, pain from head to toes |
| 50 | 2021-01-06 | retching, vomiting |
PATIENT COMPLAINED OF LIGHTHEADEDNESS, VOMITING X2, GAGGING, DROWSY, UNSTABLE, TACHYCARDIC HR 110, B...
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PATIENT COMPLAINED OF LIGHTHEADEDNESS, VOMITING X2, GAGGING, DROWSY, UNSTABLE, TACHYCARDIC HR 110, BP 142/91
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| 50 | 2021-01-06 | vomiting |
Pfizer BioNTech COVID 19 Vaccine EUA developed body aches, chills, malaise, vomiting the morning aft...
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Pfizer BioNTech COVID 19 Vaccine EUA developed body aches, chills, malaise, vomiting the morning after the vaccine
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| 50 | 2021-01-06 | vomiting |
Pfizer BioNTech COVIS 19 Vaccine EUA developed body aches, chills, malaise, vomiting the morning aft...
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Pfizer BioNTech COVIS 19 Vaccine EUA developed body aches, chills, malaise, vomiting the morning after the vaccine
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| 50 | 2021-01-06 | nausea |
warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u...
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warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u - stick neck, shoulder pain + heat, left cheek swollen been taking tylenol and benadryl saw PCP - received rx for prednisone
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| 50 | 2021-01-07 | nausea |
I experienced rigors; Extreme fatigue; Fever spiked to 102.4 in the evening, the day after vaccine.;...
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I experienced rigors; Extreme fatigue; Fever spiked to 102.4 in the evening, the day after vaccine.; Very mild headache and very mild queasiness; Very mild headache and very mild queasiness; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the left arm on 31Dec2020 at 11:45 at a single dose for COVID-19 immunization in the hospital. The patient has not have any vaccines in four weeks and did not take any medications in two weeks. The patient is not pregnant. Medical history included asthma, grade 1 casein allergy, environmental allergies, mild hypertension and high cholesterol. Concomitant medications included montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), nifedipine (PROCARDIA) and atorvastatin (LIPITOR). On 31Dec2020 at 09:00 PM, approximately 9 hours after receiving the vaccine, the patient experienced rigors which lasted much of the night. Extreme fatigue. Patient reported that ibuprofen was taken with no relief. Tylenol taken the next day. Fever spiked to 102.4 in the evening, the day after vaccine. The patient did not record her temperature overnight during rigors. The patient also reported of a very mild headache and very mild queasiness. The patient also took Benadryl, self-administered per MD. The symptoms were gone by the morning of the second day. The patient assessed the events as non-serious. The patient recovered from the events on an unspecified date in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination. Information about Lot/Batch number has been requested.
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| 50 | 2021-01-07 | nausea | Nausea, child, feeling unwell. NO fever |
| 50 | 2021-01-07 | nausea, nausea | muscle pain, chills, joint pain, nausea |
| 50 | 2021-01-07 | nausea |
sores and redness at the back of throat and tongue; sores and redness at the back of throat and tong...
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sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; numbness; tingling; burning sensation in throat and the back of tongue; burning sensation in throat and the back of tongue; mild nausea; allergic reaction; dizzy, light-headed; ashen pale; head felt heavy; Burning and itchiness on chin persists; Burning and itchiness on chin persists; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 29Dec2020 12:00 at first single dose for COVID-19 immunization. Medical history reported as none. No known allergies. Concomitant medication the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), linum usitatissimum seed oil (FLAX SEED OIL), cyanocobalamin (VITAMIN B12) and multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 min after shot the patient was dizzy, light-headed, ashen pale, and head felt heavy. After sitting and lying down about 45 min, the patient felt numbness, tingling, and a burning sensation in throat and the back of tongue. MD took O2 sat (99%) and heart rate (72). The patient felt mild nausea for 5 min. MD gave her Pepcid 20 mg as antihistamine. About 30 min later, the patient noticed sores and redness at the back of throat and tongue. The patient consulted MD and she advised the patient to go to employee health clinic. The clinic MD stated the patient was probably having some kind of allergic reaction to vaccine. The patient was given steroid shot and Benadryl 25 mg PO (per oral) and observed for 90 min. The patient left and was given Medrol Dose pack if symptoms persisted after 2 days. The patient was told to take Benadryl 25 mg PO (per oral) 4-6 hours and Pepcid 20 mg PO (per oral) BID (twice a day) for 1-2 days. Redness, sores at back of throat and tongue persist. Burning and itchiness on chin persists. The patient had no difficulty breathing at any time. Adverse event start date was reported as 29Dec2020 12:15 PM. Events were non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included: Benadryl 25 mg PO and a steroid shot IM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events sores and redness at the back of throat and tongue, burning and itchiness on chin persists not recovered, of other events was recovered with sequel.
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| 50 | 2021-01-07 | vomiting |
vomiting; severe headache; This is a spontaneous report from a contactable nurse. A 50-years-old fem...
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vomiting; severe headache; This is a spontaneous report from a contactable nurse. A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899, expiry date not reported), intramuscular on 30Dec2020 16:00 at a single dose in the left arm as Covid vaccine. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient had no known allergies; no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medications the patient received within 2 weeks of vaccination. Patient received vaccine on 30Dec2020 at 4pm. On 01Jan2021, at approximately 3am, patient woke up with a severe headache, and approximately 6am, patient started vomiting which lasted until after 7pm. The headache was not as intense but it was still there today. Since the vaccination, the patient has not been tested for COVID-19. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The outcome of the events headache and vomiting was reported as recovering.
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| 50 | 2021-01-08 | nausea |
01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and...
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01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and head congestion/sinus congestion, eyes hurt and bright red. 07:00am temp 99, took Tylenol 1000mg. 10:00am weakness and severe body aches and difficulty getting out of bed and almost fell several times and reported skin hurt. 2:57PM temp 102.7, took Tylenol 1000mg and Motrin 800mg , 06:00pm temp 100.4 took another 1000mg Tylenol and continued with symtpoms through the night and woke up around 3:30am 01/09/2021 soaking wet with sweat. 01/09/21 1:50pm continues with mild body aches and moderate headache.
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| 50 | 2021-01-08 | abdominal pain upper |
Right upper quadrant dull pain 4/10 around the liver area, has not checked liver enzymes Narrative: ...
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Right upper quadrant dull pain 4/10 around the liver area, has not checked liver enzymes Narrative: has not seeked medical care
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| 50 | 2021-01-08 | nausea | Since administration - Chest pain, Shortness of breath, blurred vision, headache, nausea, and chills |
| 50 | 2021-01-09 | nausea |
Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Start...
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Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Started getting chills at 0300, back pain started and injection arm became very painful. at 0430, got out of bed, nausea became severe and I passed out for 2 minutes. Subsequently fractured my nose from the fall after passing out and ended up in the ER for 6 hours with low blood pressure.
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| 50 | 2021-01-09 | diarrhea |
Diarrhea started after having mild chills at around 1300hrs on 1/8/2021; then followed by tiredness ...
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Diarrhea started after having mild chills at around 1300hrs on 1/8/2021; then followed by tiredness and weakness. Got home at around 1545hrs and I continued to have diarrhea all night until Saturday -all day. Diarrhea settled at around 1800hrs.
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| 50 | 2021-01-09 | nausea |
STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB,...
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STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB, NAUSEA, RASH. I STILL HAVE SOB AND I DONT KNOW IF IT WILL BE TEMP OR PERMANENT.
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| 50 | 2021-01-09 | difficulty swallowing |
Within 15 minutes of vaccine administration, I developed difficult swallowing, scratchy throat and s...
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Within 15 minutes of vaccine administration, I developed difficult swallowing, scratchy throat and severe flushing of face, neck and chest. This lasted about 1.5 hours. Symptoms resolved within 2 hours. Treated with oral Benadryl and Tylenol
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| 50 | 2021-01-10 | abdominal discomfort |
Dose 1: Chills and upset stomach by 11:00am (4hours after vaccination) until bed rest same day, pain...
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Dose 1: Chills and upset stomach by 11:00am (4hours after vaccination) until bed rest same day, pain in the site of injection making arm unable to rise more than 30 degrees from 11:00am day of vaccination until 12/20/2020
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| 50 | 2021-01-10 | nausea |
Dose 2: Chills, body ache, headache by 10:00pm (13.5hrs after vaccination 01/07/2021), severe body...
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Dose 2: Chills, body ache, headache by 10:00pm (13.5hrs after vaccination 01/07/2021), severe body ache, nausea, pain on the site of injection but mild compared to first dose, tiredness, fever from 9:00 am until bedtime on 01/08/2021
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| 50 | 2021-01-10 | nausea | body ache, fever, nausea. called in sick to work. |
| 50 | 2021-01-10 | difficulty swallowing |
fever, chills, sore throat, difficulty swallowing, body aches, joint pain, hypertensive, tightness i...
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fever, chills, sore throat, difficulty swallowing, body aches, joint pain, hypertensive, tightness in chest. Went to ER @ Hospital
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| 50 | 2021-01-10 | nausea | nausea, headache, fever. called in sick to work. |
| 50 | 2021-01-11 | nausea | Chills, body aches, migraine, nausea. Improving |
| 50 | 2021-01-11 | nausea |
Chills, body aches, terrible headache, nausea, tired for approximately 24 hours upon onset of sympto...
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Chills, body aches, terrible headache, nausea, tired for approximately 24 hours upon onset of symptoms Left axillary lymphadenopathy for approximately 3 days
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| 50 | 2021-01-11 | nausea, decreased appetite | Fever, headache, nausea, muscle spasms, sensitive to noise and light, loss of appetite, very tired |
| 50 | 2021-01-11 | nausea | INJECTION SITE, HEADACHE TIRED, CHILLS,FEVER,NAUSES,MODERATE COUGH |
| 50 | 2021-01-11 | difficulty swallowing | Pt c/o difficulty swallowing, which worsened, began coughing. Epi given IM and pt transferred to ED |
| 50 | 2021-01-11 | nausea | Received 1st dose vaccine and became nauseated, dizzy, lightheaded and almost passed out. |
| 50 | 2021-01-11 | vomiting | Severe head pain, severe muscle pain, vomiting Fever 101.8, swollen right axillary lymph node |
| 50 | 2021-01-11 | nausea | Severe muscle pain, severe headache , fever and nausea |
| 50 | 2021-01-11 | nausea |
Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; inject...
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Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; injection site soreness; shaking hands; This is a spontaneous report from a contactable other HCP reported for herself. A 50-year-old female patient received first dose of BNT162B2 (lot number: ej1686), via intramuscular in right arm, on 05Jan2021 06:30 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. Medical history included Known allergies: sulfa antibiotics, avascular necrosis, multiple joint replacements, anticoagulation, chronic pain, multiple hospitalizations in 2020 for diverticulitis. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines was received within 4 weeks prior to the COVID vaccine. Concomitant medications which patient received within 2 weeks of vaccination included warfarin, oxycodone, linaclotide (LINZESS), cyanocobalamin (VIT B12), ergocalciferol (VIT D) and iron. The patient experienced severe nausea, headache, sore throat, sweating with chills, chest pain, injection site soreness, shaking hands on 05Jan2021 07:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering.
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| 50 | 2021-01-11 | abdominal discomfort, nausea |
not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she wa...
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not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she was hot and cold; dry throat; nausea; a little stomach upset; left arm was sore for several days too; Headache; muscle ache; joint pain; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable a 50-year-old female Registered Nurse reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 11:40 on Deltoid Left at single dose for covid-19 immunisation. Medical history included was none. There were no concomitant medications. The patient experienced headache, muscle ache, joint pain, left arm was sore for several days too on 17Dec2020; not feeling well, sore, runny nose, sore throat, swollen glands, sweats, chills, feeling like she was hot and cold, dry throat, nausea, a little stomach upset on an unknown date. The detail clinical course was provided as following: the nurse reported side effects and want to verify if side effects that "keep coming and going back every couple days" are "normal". Received first dose last 17Dec2020 and felt side effects on the evening. Returned on Monday last week, lasted until Friday, and back on 06Jan2021. The patient had developed a runny nose, sore throat, and feeling like she was hot and cold. She said she had sweats and chills, but no fever. She said she kept getting a warm sensation, and checked her temperature several times, but did not have a fever. She said she had a super dry throat, and her throat felt like a desert. She said she had swollen neck glands, clarifying the swollen neck glands were underneath her mandible. She said she had nausea, and a little stomach upset with no diarrhea. She said she was still not feeling well in her stomach. Reported last week she had 3 days with a nonstop headache, swollen glands, and a sore throat. She said the headache, swollen glands, and sore throat went away, but are back again, 06Jan2021. She said she was thinking what she was experiencing was more a side effect of the COVID-19 Vaccine than being ill because her symptoms went away and now were back. She said when a person was ill, the person got through the illness, and that was it, but her symptoms kept going away and coming back. Clarified the night of 17Dec2020, she had a headache and some muscle aches and joint pain, specifically in her neck. She said her left arm was sore for several days too. She said everything went away. She said she started feeling sick again last Tuesday, 29Dec2020, and felt ill through Friday, 01Jan2021. She said over the weekend she felt fine, and then on 06Jan2021, she was feeling ill with the same symptoms of a headache, sore throat, runny nose, and swollen glands. She said she thought it was odd that the symptoms came back again. She said maybe what she was experiencing were not side effects from the COVID-19 Vaccine, and she was ill. She said it was odd that she felt bad and then felt better, and then the symptoms come back again. Reported she can work through her symptoms, clarifying she had mild symptoms. The event outcome was unknown. All events were reported as non-serious. The events did not require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks): None. Relevant Tests: None. Treatment: Declined any Reported she was scheduled to get her second COVID-19 Vaccine dose on 07Jan2021. Information on the lot/ batch number has been requested.
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| 50 | 2021-01-12 | nausea | 14 hours after dose symptoms as follows. Nauseous, fever and body aches lasting 24 hours. |
| 50 | 2021-01-12 | nausea, decreased appetite, abdominal pain upper, abdominal discomfort |
3 am woke up with stomach upset cramping, nausea, chills, took Tylenol; no appetite not eating anyth...
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3 am woke up with stomach upset cramping, nausea, chills, took Tylenol; no appetite not eating anything
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| 50 | 2021-01-12 | nausea | Patient felt intense dizziness with nausea for three hours before symptoms resolved. |
| 50 | 2021-01-12 | nausea | headache, nauseous; taking Tylenol; feel the same as when the reaction started |
| 50 | 2021-01-13 | nausea |
1/7/2021 @1600 nausea lasted 2hr 1/8/2021 @ 0200 body aches & chills lasted off & on & continues pre...
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1/7/2021 @1600 nausea lasted 2hr 1/8/2021 @ 0200 body aches & chills lasted off & on & continues presently. Woke up 1/9/2021 @0400 with headache & severe body aches & chills lasted 2hr Currently: body aches, chills, exhaustion (these symptoms come & go since 2nd injection)
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| 50 | 2021-01-13 | diarrhea |
HOSPITAL COURSE: Patient is a 50 y.o. female with a history of anxiety and migraine headaches who pr...
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HOSPITAL COURSE: Patient is a 50 y.o. female with a history of anxiety and migraine headaches who presented to hospital with cough and diarrhea. The patient had felt the symptoms on 12/31/2020 and eventually went to have a COVID test on 1/1/2021. She was subsequently positive but due to dehydration and diarrhea she came to the emergency department where she was admitted for remdesivir and dexamethasone. She was able to be weaned off any supplemental oxygen. Her diarrhea resolved. She is feeling well and will be discharged home in good condition.
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| 50 | 2021-01-13 | abdominal pain |
Reported chills, shaking cold sweats throughout the whole night, fever of 102F, body aches and abdo...
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Reported chills, shaking cold sweats throughout the whole night, fever of 102F, body aches and abdominal pain.
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| 50 | 2021-01-13 | nausea |
bad headache(9) for at least 3hrs my head still hurts (5) all day and today.... nausea joint pain c...
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bad headache(9) for at least 3hrs my head still hurts (5) all day and today.... nausea joint pain chills
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| 50 | 2021-01-13 | nausea | body aches, nausea |
| 50 | 2021-01-13 | abdominal distension |
having gas/bloating since receiving the vaccine; This is a spontaneous report from a non-contactable...
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having gas/bloating since receiving the vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 06Jan2021 at 10:30 AM at a single dose on the right arm for COVID-19 immunization. The patient was vaccinated in the nursing home/senior living facility. The patient was not administered any other vaccine in four weeks. The patient's medical history was not reported. Concomitant medication included levothyroxine (manufacturer unknown), vitamin d (manufacturer unknown), zinc (manufacturer unknown), Claritin (unspecified generic name) and unspecified vitamins. The patient previously took amoxicillin and experienced allergies. It was reported that the patient has been having gas/bloating since receiving the vaccine on 07Jan2021 at 16:00 (reported as 4:00 PM). The patient received over the counter gas medicine as treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 50 | 2021-01-14 | difficulty swallowing |
10:40 Employee complains of difficulties swallowing, sensation in throat. Denies troubles breathing....
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10:40 Employee complains of difficulties swallowing, sensation in throat. Denies troubles breathing. Is experiencing watering eyes and occasional coughing 10:49- received dose of 25mg diphenhydramine with slight improvement in symptoms, not resolved. 10:52- notes sensation of tingling tongue- Emergency Response Team called 11:02- 2nd dose of 25mg PO diphenhydramine administered Emergency Response Team Staff transports Employee to Emergency Room
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| 50 | 2021-01-14 | retching, nausea |
1340-EE c/o nauseated( with heaves but no emesis), dizziness, with a severe HA. BP 193/83 HR 62 O2 ...
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1340-EE c/o nauseated( with heaves but no emesis), dizziness, with a severe HA. BP 193/83 HR 62 O2 88-96%RA; 1345-EE to ED room 14 for further evaluation.
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| 50 | 2021-01-14 | nausea |
Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to ...
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Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to floor with feet elevated. BP: 112/52 Reported Tingling lips- administered diphenhydramine 50mg at 12:36 1239: 122/78 1245: Feeling better, sat up in chair 12:56: Another wave of heat, nausea, dizziness- lied to floor. drank water. Denies breathing or troubles swallowing . Lip tingling has resolved
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| 50 | 2021-01-14 | nausea |
I woke up at 12:39am feeling nauseous and with a pounding heartbeat. I also had a headache and seve...
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I woke up at 12:39am feeling nauseous and with a pounding heartbeat. I also had a headache and severe body aches, and chills, but no fever. I drank some water and sat up in bed for a while. The pounding heartbeat settled down in about half an hour. I did not take Advil or anything else because of the nausea. Later in the morning I had some nasal congestion. Symptoms persisted but slowly waned until 6:00pm that day. After that, fatigue was the only symptom that lasted until about the 48 hour mark.
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| 50 | 2021-01-14 | nausea |
Sx - mild wheezing, mild headache, mild nausea, muscular pain injection site. Tx- self administered ...
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Sx - mild wheezing, mild headache, mild nausea, muscular pain injection site. Tx- self administered inhaler
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| 50 | 2021-01-14 | nausea, diarrhea, decreased appetite |
diarrhea; nausea; loss of appetite; chills; body aches; malaise; headache; sore throat; This is a sp...
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diarrhea; nausea; loss of appetite; chills; body aches; malaise; headache; sore throat; This is a spontaneous report from a contactable nurse, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EH9899), intramuscular in the left arm from on 16Dec2020 20:00 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, thyroid nodule, and known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 17Dec2020 20:00, 24 hours after receiving the first dose of BNT162B2 the patient experienced chills, body aches, malaise, headache and sore throat. On 18Dec2020 20:00, 48 hours after receiving the first dose of BNT162B2 the patient experienced diarrhea, nausea and loss of appetite. The patient was treated for the chills, body aches/malaise, headache and sore throat, diarrhea, nausea and loss of appetite with ibuprofen (Manufacturer Unknown). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events, chills, body aches/malaise, headache, sore throat, diarrhea, nausea and loss of appetite, were all recovered on an unknown date. No follow-up attempts possible. No further information is expected.
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| 50 | 2021-01-15 | vomiting, diarrhea | Fever, chills, vomiting, cough, diarrhea, painful lump at injection site, fatigue |
| 50 | 2021-01-15 | diarrhea |
I had the first vaccine 12/22, no side effects at all. After this booster, I was fine until about 1...
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I had the first vaccine 12/22, no side effects at all. After this booster, I was fine until about 10 hours later-then had severe neck down my entire back pain, with restlessness, chills, and headache-this lasted about 24 hrs. The pain subsided and then I had liquid stooling for about 8 hrs with intermittent hot flashes. I am still having an "odd" feeling in my head, like foggy sensation, vertigo, and the sweating episodes as we speak.
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| 50 | 2021-01-15 | diarrhea, abdominal pain |
I received my 2nd covid vaccination on 01/11/21. I started feeling muscle aches about 2 hours after ...
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I received my 2nd covid vaccination on 01/11/21. I started feeling muscle aches about 2 hours after vaccination. On Tuesday I went to work and was getting worse. on Wed, I have severe muscle aches, severe headache, abdominal pain, diarrhea. on Thursday, I was feeling a little better and returned back to work on Friday
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| 50 | 2021-01-15 | nausea |
nausea, swollen around injection site, arm very painful for 2 days, persistent headache, and extreme...
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nausea, swollen around injection site, arm very painful for 2 days, persistent headache, and extreme exhaustion. I had to leave work early and take the next day off. I slept 14 hours on that day off.
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| 50 | 2021-01-17 | nausea |
I got a fever 101 the day after shot , I had chills , my bones hurt the pain was very intense in rel...
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I got a fever 101 the day after shot , I had chills , my bones hurt the pain was very intense in relived by Motrin and Tylenol , intense pain at injection site my underarms hurt very badly / nausea/ intense fatigue all about 20 hours after injection hit me hard like a wall - this went on for 24 hrs then I felt better but felt very weak for 2 more day s- to day is 6 days after injection first day I feel normal again
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| 50 | 2021-01-17 | nausea |
I have a fever, it maxed of this morning at 101.5; Nauseous; Body ache; Arm hurts; Chills; This is a...
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I have a fever, it maxed of this morning at 101.5; Nauseous; Body ache; Arm hurts; Chills; This is a spontaneous report from a contactable nurse (patient). This 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK9231), via an unspecified route of administration, on 06Jan2021 at 5:15 at single dose for COVID-19 immunisation. Vaccine location was left shoulder. The patient was vaccinated at hospital, age at vaccination was 50-years-old. Medical history and concomitant medications were none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE an unknown date. Nurse stated she was just reporting some side effects from COVID Vaccine. She had second one last night at 5:15 and she is a nurse and she worked over night which she would never do that again. So, she has a fever, it maxed of this morning at 101.5 and chills, body ache, and she feels nauseous, and her arm hurts. Nausea was first at about 1:30 in this morning (07Jan2021) and then chills and then fever by about quarter to 6 this morning (07Jan2021), she started to check her temperature. Outcome was not recovered. No treatment was received for the events. She just didn't wanted to mask the fever. She wanted to see how it developed and her highest temperature was 101.5, then it came down a little bit, it's tolerable. About causality, nurse stated Yeah, most definitely.
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| 50 | 2021-01-17 | nausea | Low fever, chills, aching all over the body, naseau |
| 50 | 2021-01-17 | nausea | Nausea, Headache, Body aches. No treatment. Felt better after 24 hours of vaccine. |
| 50 | 2021-01-17 | nausea |
Nausea, Headache, Joint swelling (couldnt make a fist), Pins and Needles on palms of hands, Pins and...
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Nausea, Headache, Joint swelling (couldnt make a fist), Pins and Needles on palms of hands, Pins and Needles bottom of feet,Burning feeling the bottom of feet, body aches, fatigue. No treatment. Event ended 30 hours after vaccine.
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| 50 | 2021-01-17 | abdominal discomfort, nausea |
Woke up on 1/15 with dry, irritated nose, mild nausea. My nose continued to get stuffier as the day ...
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Woke up on 1/15 with dry, irritated nose, mild nausea. My nose continued to get stuffier as the day went on and I began to have a slight headache. On 1/16 my nose was very stopped up and I had a constant headache and an upset stomach, fatigue. On 1/17 I was very stopped up with a intense headache. Today, 1/18 my symptoms are much better.
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| 50 | 2021-01-18 | nausea | Chills, feeling unwell, mild nausea lasting 5 hours |
| 50 | 2021-01-18 | nausea, diarrhea |
Numb lips within 15 min, along with chills, headache and nausea. Followed by sore throat and runny n...
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Numb lips within 15 min, along with chills, headache and nausea. Followed by sore throat and runny nose. I had taken Benadryl and Prednisone before hand because had all above symptoms with first Pfizer shot (EJ1685). The following days I had severe headaches with nausea and dizziness and lethargy as well as diarrhea. Four days later after the shot on the 1/15 I experienced fluid accumulation in the lungs followed by burning sensation on the tongue, numb lips, and a sensation of swelling in the inner lining of the throat. With Benadryl symptoms subsided.
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| 50 | 2021-01-18 | diarrhea |
Severe arm pain after shot. Woke me out of sleep night after shot. Unable to lift arm horizontal t...
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Severe arm pain after shot. Woke me out of sleep night after shot. Unable to lift arm horizontal to shoulder, knot size of walnut. Diarrhea x 24 hrs, headache, low grade temp, wheezing day 4, shortness of breath noted upon exertion day 3-7. Expiratory wheezing. Much better (able to walk without shortness of breath day 7). Laryngitis day 2-6. Went to ER. Received IVF for low potassium and dehydration due to diarrhea. T max 99.9.
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| 50 | 2021-01-18 | diarrhea, diarrhea | rapid heart rate, fever, diarrhea. called in sick to work. |
| 50 | 2021-01-18 | diarrhea | swelling pain in arm on injection site body aches fever diarrhea |
| 50 | 2021-01-19 | nausea, diarrhea |
1/18 10pm started with chills then fever 1/19 not feeling right 8am chills 10am fever 101.1 severe n...
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1/18 10pm started with chills then fever 1/19 not feeling right 8am chills 10am fever 101.1 severe nausea near vomiting severe fatigue had fever all night 11/20 diarrhea put no fever
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| 50 | 2021-01-19 | abdominal pain upper | Chills, headache, stomach/groin cramping, low grade fever. Took ibuprofen 800 mg |
| 50 | 2021-01-19 | vomiting, diarrhea |
Had fever, chills, vomiting, diarrhea fatigue starting 12/22 fever stop 12/23 other symptoms stayed ...
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Had fever, chills, vomiting, diarrhea fatigue starting 12/22 fever stop 12/23 other symptoms stayed until 12/26. 12/27 started with fever again symptoms came back and was tested12/28 and 12/29, 12/29 was negative 12/28 was positive 1/12 pneumonia
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| 50 | 2021-01-19 | nausea | Palpitation, shortness of breath, dizzy, nausea, headache, pain on injection site |
| 50 | 2021-01-19 | nausea | chills, fever, muscle pain , nausea , |
| 50 | 2021-01-19 | difficulty swallowing |
perioral numbness with HA. Difficulty swallowing & breathing. Pt felt it was likely due to the N95...
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perioral numbness with HA. Difficulty swallowing & breathing. Pt felt it was likely due to the N95 mask. Given procedural mask and reported improvement of symptoms. Rapid response contacted. No other intervention
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| 50 | 2021-01-20 | diarrhea, abdominal pain upper |
At 8 am, this morning, sharp pains in my stomach started , earlier had some diarrhea , had bouts of ...
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At 8 am, this morning, sharp pains in my stomach started , earlier had some diarrhea , had bouts of diarrhea a couple times after. Stomach having sharp pains and body chills no fever
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| 50 | 2021-01-20 | vomiting |
I had headache, dizziness, body aches, vomiting, joint pain. I have to take the day off of work af...
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I had headache, dizziness, body aches, vomiting, joint pain. I have to take the day off of work after my first and my second vaccine. I rotated ibuprofen and Tylenol. The first vaccine reaction lasted about 36 hours. The second is going on 48 hours.
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| 50 | 2021-01-20 | nausea |
Nausea next morning, Then developed a headache in back of head that lasted several days, went to urg...
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Nausea next morning, Then developed a headache in back of head that lasted several days, went to urgent care on 1/16/2221 due to headache still there. Was treated and sent home, headache continued until 01/19/21. Second shot given on 01/20/21, resulted in fatigue, and headache returning after injection.
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| 50 | 2021-01-20 | nausea |
She report receipt of vaccine and 30-45 minutes later experienced severe headache, nausea, scratchy ...
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She report receipt of vaccine and 30-45 minutes later experienced severe headache, nausea, scratchy throat and loss of voice and breathing was 'heavy'. She reports pallor, increased heart rate and near syncope. She denies pruritis, urticaria, flushing, watery eyes, face/tongue or lip swelling, CP, cough. She was seen in ER and treated with zofran, pepcid, solumedrol, monitored and then released. ER records note tachycardia at 107 but otherwise normal VS and exam. .
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| 50 | 2021-01-20 | nausea | chills fever exhaustion nausea red and swollen at the injection site |
| 50 | 2021-01-20 | nausea, diarrhea |
diarrhea; nausea; she was sick with a high fever; chills; felt deathly sick; couldn't get out of bed...
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diarrhea; nausea; she was sick with a high fever; chills; felt deathly sick; couldn't get out of bed all day; headache; a little bit of a sore throat; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, lot # and expiration not available) intramuscular in left arm at single dose on 11Jan2021 09:30 for Covid-19 immunisation, for precaution because she worked in hospital, administered ad hospital. There was no prescriber. Medical history included asthma diagnosed 30 years before when she was in her 20's around 1990, hypothyroidism. Family medical history was none. Concomitant medication included only levothyroxine sodium (SYNTHROID) taking for 30 years for hypothyroidism. The patient received the 1st dose of bnt162b2 (BNT162B2, lot # and expiration not available) intramuscularly in left arm on 21Dec2020 09:30 (within 4 weeks prior to the 2nd dose of BNT162B2 suspect) Covid-19 immunisation and she was fine. No adverse events occurred following prior vaccinations. No additional vaccines administered on same date of BNT162B2 suspect. On 12Jan2021, she was felt deathly sick at 15:00. On 11Jan2021 she experienced headache at 17:00. On 12Jan2021, at 17:00 she experienced high fever and chills and couldn't get out of bed all day. On 13Jan2021, she was fine during the day. On 13Jan2021 night, she had a fever that went past 100 degree F, she experienced diarrhea and nausea 02:00. The fever came and went. In Jan2021 she had a little bit of a sore throat. The patient underwent lab tests and procedures which included body temperature: a fever on 12Jan2021; wsa fien on 13-JAN-2021, fever went past 100 degree F, on 13Jan2021at night. No other relevant test performed. She has been out of work since 12Jan2021. On 14Jan2021 she still has diarrhea and nausea with a little bit of a sore throat as well. No ER or physician's office was required. The outcome of felt deathly sick and chills was recovering, of headache, high fever, diarrhea and nausea was not recovered, of couldn't get out of bed all day and a little bit of a sore throat was unknown. She was not sure if her new symptoms meant she should get COVID testing and would like to find out. Information on lot number/batch number was requested.
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| 50 | 2021-01-20 | nausea |
inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); ...
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inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); Temp 102; body aches; chills; lymph node in right armpit swelling sz golf ball; vertigo all lasted 2.5 days; migraine pain >10 on pain scale; rash on hands and arms; nausea; blurred vision; Ongoing headache and body aches 5 days now; This is a spontaneous report from a contactable Nurse (patient). A 50-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 07Jan2020 at 09:00 a.m. intramuscular on right arm at single dose for COVID-19 immunization. Relevant medical history included hypothyroidism, post-traumatic stress disorder, anxiety and allergy to tetracycline. Concomitant medications included escitalopram oxalate (LEXAPRO), celecoxib (CELEBREX), levothyroxine, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and paracetamol (TYLENOL). The patient received first dose of BNT162B2 on 18Dec2020 at 04:00p.m. intramuscular on right arm. On 07Jan2021 at 11:00 a.m. the patient experienced pyrexia with temperature of 102, body aches, chills, lymph node in right armpit swelling sz golf ball (as reported), nausea, migraine pain >10 on pain scale (as reported), rash on hands and arms, blurred vision and headache. On 08Jan2021 the patient underwent Nasal Swab SARS-CoV-2 test (Abbott) which resulted negative. No Treatment received for events. The patient recovered from vertigo on 09Jan2021. At the time of the reporting the patient had not yet recovered from headache and body aches, while was recovering from other reported events. Information about Lot/Batch number has been requested.
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| 50 | 2021-01-21 | nausea |
Approximately 15 hours after vaccine, she noticed chills, fever up to 100.6, severe headache, fatigu...
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Approximately 15 hours after vaccine, she noticed chills, fever up to 100.6, severe headache, fatigue and nausea. About a day later she noted lightheadedness. About 1 days later she noticed soreness at the injection site and sensitivity to cold.
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| 50 | 2021-01-21 | diarrhea | Headache, diarrhea, body aches |
| 50 | 2021-01-21 | nausea |
On the 20th, had significant nausea that improved with zofran, and on the 21st, my ears started burn...
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On the 20th, had significant nausea that improved with zofran, and on the 21st, my ears started burning and when I looked in the mirror saw that they were extremely red, and then saw that my neck was red, pulled my long sleeves up and noticed a rash forming and within 5 minutes had a full blown body rash and redness; I was given a Benadryl and then I drove to the Urgent Care Clinic and was treated with Dexamethasone, and a Pepcid which resolved the rash within 20 minutes .
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| 50 | 2021-01-21 | nausea | Patient became nauseous, diaphoretic, dizzy and felt as if she was going to "pass out" |
| 50 | 2021-01-21 | diarrhea, nausea, abdominal discomfort |
Severe burning sensation in mid-abdominal, nausea, chronic diarrhea every 2-3 day since 1st dose and...
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Severe burning sensation in mid-abdominal, nausea, chronic diarrhea every 2-3 day since 1st dose and daily since 2nd dose on 09Jan2021; Severe burning sensation in mid-abdominal, nausea, chronic diarrhea every 2-3 day since 1st dose and daily since 2nd dose on 09Jan2021; Severe burning sensation in mid-abdominal, nausea, chronic diarrhea every 2-3 day since 1st dose and daily since 2nd dose on 09Jan2021; This is a spontaneous report from a contactable other HCP (patient). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730; expiration date not provided), intramuscular (anatomical location: arm left) on 19Dec2020 at single dose, then second dose intramuscular (anatomical location: not provided) on 09Jan2021 (lot number and expiration date not provided) at single dose for COVID-19 immunisation. Patient is not pregnant. Medical history was reported as none. Concomitant medications included sumatriptan, escitalopram oxalate (LEXAPRO), and ascorbic acid, betacarotene, biotin, capsicum annuum fruit, colecalciferol, collagen marine, curcuma longa, cysteine hydrochloride, equisetum arvense, fallopia japonica, hyaluronic acid, iodine, keratin, lysine, methionine, piper nigrum, selenium, serenoa repens, tocotrienols nos, withania somnifera, zinc (NUTRAFOL), also reported as Woman's Balance. The patient did not receive other vaccine in four weeks. The patient has no known allergies. The patient has no COVID prior vaccination. On 27Dec2020, the patient experienced severe burning sensation in mid-abdominal, nausea, and chronic diarrhea every 2-3 day since 1st dose and daily since 2nd dose on 09Jan2021. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit. It was reported that patient received anti-nausea prescription and loperamide (IMODIUM AD) as treatment for the events. Patient was not COVID tested post vaccination. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 50 | 2021-01-22 | diarrhea, vomiting | Fever, chills, tachycardia, muscle aches, vomiting, diarrhea. Lasted 24hours, then resolved. |
| 50 | 2021-01-23 | nausea |
Extreme joint pain, headache, nausea, exhaustion for 48 hours. As of today 1/24/20 im still experien...
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Extreme joint pain, headache, nausea, exhaustion for 48 hours. As of today 1/24/20 im still experiencing tightness in my chest and some difficulty breathing, breathing heavily.
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| 50 | 2021-01-23 | nausea | Nausea fatigue chills body aches low energy |
| 50 | 2021-01-23 | nausea |
Nausea, fever, chills, headache, severe muscle and joint aches, fatigue, blurry vision. Took Tyleno...
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Nausea, fever, chills, headache, severe muscle and joint aches, fatigue, blurry vision. Took Tylenol and Ibuprofen.
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| 50 | 2021-01-24 | nausea |
Severe headache with sharp pains in neck and head; sharp pains in neck; severe muscle and joint pain...
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Severe headache with sharp pains in neck and head; sharp pains in neck; severe muscle and joint pains entire body from feet to hands; severe muscle and joint pains entire body from feet to hands; mild chills; fatigue; mild nausea; temperature 101.7; This is a spontaneous report from a contactable Nurse reporting for herself. A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), on 12Jan2021 at 12:30 at single dose intramuscular in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Age at vaccination was 50 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140) on 22Dec2020 at 12:45PM, at single dose intramuscular in left arm. Medical history included Long QT syndrome, chronic pain, and depression. The patient has no known allergies. Concomitant medications included metoprolol, bupropion, fluoxetine, omeprazole, pregabalin (LYRICA), cyanocobalamin (VITAMIN B-12), vitamin D3. On 12Jan2021 at 08:30PM the patient experienced severe headache, with sharp pains in neck and head; severe muscle and joint pains entire body from feet to hands; mild chills, temperature 101.7; fatigue, mild nausea. The patient received the following treatments for the events: treatment medications (Metaxalone, Vicodin, Lyrica) and OTC meds (Tylenol, Advil, Aleve, vitamin B-12 & D3). The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19.
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| 50 | 2021-01-25 | nausea |
Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills;...
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Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills; Mild dizziness; Intermittent heart racing; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 11Jan2021 (20:00) at single dose for Covid-19 immunization. The patient received the first dose of COVID 19 vaccine (BNT162B2, lot number: EJ1685), via an unspecified route of administration (left arm) on 21Dec2020 (03:30 PM) at single dose for Covid-19 immunization. The patient's medical history included idiopathic neuropathy to bilateral feet; no known allergies. Concomitant medication included tramadol. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, headache, body aches more in the legs, low grade fever, chills, mild dizziness, and intermittent heart racing on 12Jan2021 (08:00 AM). There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
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| 50 | 2021-01-25 | nausea |
fatigue not resolved, muscle and joint pain severe all over body that has lessened but not resolved,...
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fatigue not resolved, muscle and joint pain severe all over body that has lessened but not resolved, intermittent nausea headache, feel feverish but no fever, weakness
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| 50 | 2021-01-25 | vomiting, nausea |
headache; alternating feeling hot and cold; vomited; shaking chills; nausea; This is a spontaneous r...
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headache; alternating feeling hot and cold; vomited; shaking chills; nausea; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration (left arm) on 06Jan2021 09:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 16Dec2020 (09:00 AM) for Covid-19 immunization. Medical history included hypothyroidism; no known allergies. Concomitant medications included levothyroxine, macrogol 3350 (MIRALAX), docusate sodium (COLACE), and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dihydrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, lycopene, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, xantofyl, zinc oxide (CENTRUM FOR WOMEN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that it was the second dose of her Pfizer COVID vaccine series; 12 hours afterwards she got shaking chills and nausea (06Jan2021) and this continued overnight, no fever. The next morning, she had the worst headache of her life, and nausea and alternating feeling hot and cold, no more shaking chills and no fever. The patient reported that it continued throughout 07Jan2021, and on 07Jan2021 she vomited once. Then 08Jan2021 in the morning, she still had the worst headache of her life, she took Ibuprofen to which the headache became much diminished. But headache continued with less intensity, so she was able to go to work throughout 08Jan2021. She continued with Ibuprofen and added Tylenol. Then at 3 am on 09Jan2021, she woke with the worst headache again so severe and took both Ibuprofen and Tylenol and it got better. By afternoon 09Jan2021, she was back to herself with no more headache and a normal appetite. She did take a sick day on 07Jan2021. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 post vaccination.
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| 50 | 2021-01-25 | diarrhea |
pt stated she was feverish, had headache and fatigue for about 1 1/2 days after covid vax. Pt state...
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pt stated she was feverish, had headache and fatigue for about 1 1/2 days after covid vax. Pt stated she started having diarrhea and developed a itchy nodule on the left side of her neck about a week later along w/ fatigue. Pt has an appt w/ ENT Dr. tomorrow 1/27/2021.
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| 50 | 2021-01-25 | nausea |
upper respiratory infection; Fatigue; Headache; Ringing of the ears/Ringing in ears; Nausea; This is...
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upper respiratory infection; Fatigue; Headache; Ringing of the ears/Ringing in ears; Nausea; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142, expiry date: unknown), via an unspecified route of administration on 04Jan2021 10:25 at single dose (left upper arm) for COVID-19 immunization. Medical history included asthma (diagnosed at 8 years old), covid from 2020 (she had Covid last year twice). There were no concomitant medications. The patient experienced nausea, headache, and ringing of the ears/ringing in ears on 04Jan2021; and fatigue on 05Jan2021. This went on for 2.5 days. By day 3 post vaccine (06Jan2021) got upper respiratory infection. Stated she is pre disposed because she is asthmatic. She states she took Zofran to treat the nausea, 8 mg, and that she took 1000mg Tylenol for the headache. States she received the vaccine at her employer, (healthcare center name). States the symptoms resolved after about 3 days, exact dates unknown. She wanted to know if the second vaccination is the exact same as the first. She wanted to know if Pfizer manufactures the Shingrix vaccine. Therapeutic measures were taken as a result of nausea, headache. The outcome of the event upper respiratory infection was unknown, while for other events was recovered on an unspecified date in Jan2021.
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| 50 | 2021-01-26 | nausea |
1st dose on 12/31/2020. Within 5 minutes of vaccine became severely dizzy, became briefly tachycard...
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1st dose on 12/31/2020. Within 5 minutes of vaccine became severely dizzy, became briefly tachycardic with diffuse warmth and claminess. EMS was called after it didn't resolve after 20-30 minutes. Blood sugar 123. BP was elevated to high 160's over high 90s. EMS transported me to the ER. 1 liter of fluids given and BP was back to normal. Head CT scan was done and was normal. Dizziness persisted for about 6 hours and I was very tired for the rest of the day with achiness noted in the evening. I was fine by the next day. 2nd dose received on 1/21/21. I had only slight dizziness after that dose and was able to leave after 30 minutes observation time. Was very tired the weekend following vaccine and have had periods of dizziness/nausea since Sunday1/24/2021. I am still feeling dizzy and nauseated 1/27/21 and was encouraged to report possible side effect to the vaccine.
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| 50 | 2021-01-26 | abdominal pain |
Flushing, abdominal cramping, and throat fullness and pressure (globus sensation) IV push meds - S...
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Flushing, abdominal cramping, and throat fullness and pressure (globus sensation) IV push meds - Solu-Medrol, Benadryl and Famotidine Resolution of symptoms after medication administration. Diagnosis - Allergic reaction to COVID-19 vaccine
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| 50 | 2021-01-26 | nausea |
Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea;...
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Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea; she said she was really pale, so much so, that her husband was scared for her; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left deltoid on 22Dec2020 07:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On to 22Dec2020, she said she feels like she has had a severe reaction to the COVID-19 Vaccine, saying she was not doing so great. Reported she received her first COVID-19 Vaccine dose on 22Dec2020 at 7:00AM in her left Deltoid. She said she had a reaction after receiving the first dose of the COVID- 19 Vaccine. She said her lips were tingling slightly, clarifying her lips were swollen too. She said she took some Benadryl (she clarified she did not have the Benadryl NDC/UPC, Lot or Expiration Date), and the Benadryl took away the lip tingling and swelling. She said she was tachypneic, and developed muscle pains (clarified as myalgia), joint pain, severe headache, weakness, and nausea. She said she also was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago, Dec2020 and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID- 19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. The outcome of the events joint pain,. myalgia, tachypnic, headache, pale and nausea was recovered on an unknown date in Dec2020; the outcome of the event tingling lips and swollen lips was recovered on 22Dec2020; while the outcome of weakness was unknown. The events were assessed as medically significant and causality was reported as related.; Sender's Comments: Based on the close compatible temporal association, there was a reasonable possibility that the events were related to the vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-26 | nausea |
involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscl...
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involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscle cramping; chest pain; Feels bad; severe joint aches; tremor; nausea; severe body pain in her back and knees; severe body pain in her back and knees; Weakness; Headache; This is a spontaneous report from a contactable Other HCP reported for self. This 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 07:00 on Deltoid Left at single dose (Lot # EK9231) for covid-19 immunisation. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 via Intramuscular at age of 50 years old on Deltoid, Left at single dose (Lot # EH9899) for covid-19 immunisation, experienced Tingling lips, Swollen lips, and the Benadryl took away the lip tingling and swelling, Tachypnea, Myalgia, Joint pain, severe headache, Weakness generalized, Nausea, she said she was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. Reported she received the second COVID-19 Vaccine dose on 12Jan2021 at 7:00AM in the left Deltoid. She said the adverse reaction she experienced after the second vaccine dose was slightly different from what she experienced with the first dose. She said about 10 hours after the COVID-19 Vaccine was administered, clarifying at around 17:00PM 12Jan2021, she started having severe body aches(disability), and involuntary muscle cramping (disability), like tetanus. She said even her diaphragm was cramping. She said she had chest pain on 12Jan2021(disability), tremors on 12Jan2021 (medically significant), and body aches, but doesn't think she had fever. She said the symptoms are still going on like with the first COVID-19 Vaccine dose, but she has more severe joint aching on 12Jan2021 (disability), weakness on 12Jan2021 (disability), and nausea on 12Jan2021 (medically significant). She said her knees feel like she was beaten severely. She said she aches so bad, it hurts having pants on. She said she does not have a headache or tremors now, but did have a headache on 12Jan2021 (medically significant) and tremors in the beginning. She said she feels the most pain in her back and knees. She said she feels really bad on 12Jan2021(disability). After the second dose on 12Jan2021, she reports severe body pain in her back and knees (disability). She reports almost feeling like she has tetanus- involuntary muscle contractions in her diaphragm on unknown date(disability), tremor, cold, chills, nausea, muscle cramps/chest pain. 'Felt like a heart attack. It was out of this world'. She still has nausea, severe pain all over my body, she can't be touched, and even wearing pants hurts. She said she is a healthy person with no chronic disease. She said she had nothing wrong with her prior to getting the COVID-19 Vaccine. Reported she hurts so bad, she can't even lift her arm. She completed a covid 19 PCR test after the first dose in Dec2020, which was negative. Treatment were received for the events severe body pain in her back and knees, involuntary muscle contractions in her diaphragm, tremor, nausea, muscle cramping, chest pain, Feels bad, more severe joint aching, severe body aches, Weakness, headache, chills, cold. Reported she has taken 1500mg of Motrin. Outcome of the severe body aches, Involuntary muscle cramping, Chest pain, severe joint aches, weakness, Nausea, Back pain, Knee pain, Feels bad was not recovered. Outcome of the event Tremor was recovered in Jan2021, Headache was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-26 | nausea |
nausea, joint pain, muscle pain, headache, chills, insomnia, tiredness, injection pain, don't feel w...
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nausea, joint pain, muscle pain, headache, chills, insomnia, tiredness, injection pain, don't feel well
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| 50 | 2021-01-26 | nausea, diarrhea |
pain in arm difficult breathing cant breath through mouth spine hurts lower legs hurt fever headache...
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pain in arm difficult breathing cant breath through mouth spine hurts lower legs hurt fever headache nausea diarrhea
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| 50 | 2021-01-26 | nausea |
sudden onset of nausea/dizziness, headache, severe chills and shaking, extreme body aches that laste...
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sudden onset of nausea/dizziness, headache, severe chills and shaking, extreme body aches that lasted approximately 10 hours, followed by extreme fatigue that lasted about 10 hours.
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| 50 | 2021-01-27 | nausea |
Customer received FIRST COVID-19 vaccine at 1015 in medical center and transferred to post vaccine o...
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Customer received FIRST COVID-19 vaccine at 1015 in medical center and transferred to post vaccine observation. At 1035 customer called out to provider. Customer reports feeling acute nausea and she states she feels as if she is going to throw up. She appears slightly pale and significantly anxious. Customer is moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. Reports feeling sweaty, with waves of nausea and intermittent ULQ pain that she describes as sharp and bandlike across the diaphragm. She episodically calls out in pain and clutches her left chest below her ribs stating that it feels better when she puts pressure at the site. Customer admits to having significant anxiety and a history of panic attacks. HR 102, 02 99%. Lungs CTA. Customer accepts Benadryl 50mg PO @ 1043. Customer monitored at site. Over the course of the next 15 minutes, she reports feeling better and more relaxed. Customer reports full resolution of symptoms @ 1100. BP 108/82, P 101, O2 100% RA, RR 16. Customer is agreeable to extended monitoring after receiving Benadryl. She has been driven to the vaccination site by a family member and states she will not be alone at home. She is instructed to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer agrees with plan and denies further questions/concerns. Customer released from site at 1115, ambulating independently with steady gait, no obvious s/sx of distress.
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| 50 | 2021-01-27 | nausea, diarrhea | Headache, Nausea, Body Aches, Diarrhee. |
| 50 | 2021-01-27 | nausea, vomiting |
Nausea; Blood pressure elevated; Tachycardia; Vomiting; This is a spontaneous report from a contacta...
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Nausea; Blood pressure elevated; Tachycardia; Vomiting; This is a spontaneous report from a contactable consumer. A 50-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular from 23Dec2020 11:30 to 23Dec2020 11:30 and from 13Jan2021 13:30 to 13Jan2021 13:30 both intramuscular arm right at SINGLE DOSE for covid-19 immunisation. Medical history included migraine from Feb2015 and ongoing. There were no concomitant medications. The patient stated that she has chronic migraines and takes medications to keep her at a level where she can function. She was on them prior to taking this and did not think they were relevant. She was diagnosed in Feb2015. On 23Dec2020 at 12:00, the patient experienced nausea, blood pressure elevated, tachycardia and vomiting. The patient also stated that she had the same symptoms of events on her second dose. Outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 50 | 2021-01-27 | nausea |
feeling tight in my lungs; feel tired; spacy; body aches; my limbs felt heavy; gastrointestinal issu...
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feeling tight in my lungs; feel tired; spacy; body aches; my limbs felt heavy; gastrointestinal issues; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (lot number: Ek4176), via an unspecified route of administration on 13Jan2021 08:00 in right arm at single dose for COVID-19 immunization. Medical history included asthma, thyroid cancer, thyroidectomy, attention deficit hyperactivity disorder (ADHD), and known allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), paracetamol (TYLENOL), salbutamol (ALBUTEROL HFA), budesonide/formoterol fumarate (SYMBICORT), and tiotropium bromide (SPIRIVA). The patient previously took azithromycin (ZPACK), and benzonatate and experienced drug allergy, and first dose of BNT162B2 (lot number: EJ1685) on 23Dec2020 08:00 in arm for COVID-19 immunization. The patient experienced feeling tight in lungs 45 min after on 13Jan2021 09:00, it lasted approximately 30 minutes. Around 3-4 hours after started to feel tired, spacy and body aches. Her limbs felt heavy, and gastrointestinal issues, nausea (ondansetron (ZOFRAN) took care of that issue) no vomiting on 13Jan2021, was brought home from work. And slept for 3 hours. Woke up and have continued body aches. The patient underwent lab tests and procedures which included nasal swab: negative on 04Jan2021. Therapeutic measures were taken as a result of nausea. Outcome of event body aches was not resolved and of other events was unknown.
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| 50 | 2021-01-27 | nausea, vomiting | immediately nausea and vomiting |
| 50 | 2021-01-28 | nausea |
Fever; Muscle pain; Joint pain; Headache; Nausea; Dizziness; This is a spontaneous report from a Non...
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Fever; Muscle pain; Joint pain; Headache; Nausea; Dizziness; This is a spontaneous report from a Non-contactable Other Healthcare Professional (HCP, also the patient). A 50-year-old female patient (not pregnant) received bnt162b2, via an unspecified route of administration on 16Jan2021 12:00 at single dose in left arm for COVID-19 immunisation. Medical history included known allergies to penicillin. The patient's concomitant medications were not reported. The patient didn't have other vaccines in four weeks. The patient didn't have COVID prior vaccination. The patient experienced fever, muscle pain, joint pain, headache, nausea and dizziness on 17Jan2021 04:00 AM . No treatment was received for the events. The outcome of the events was recovering. COVID was not tested post vaccination. Information on lot/batch number has been requested.
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| 50 | 2021-01-28 | vomiting, nausea |
Starting one day after the vaccine, I developed a headache which turned into a migraine within 24 ho...
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Starting one day after the vaccine, I developed a headache which turned into a migraine within 24 hours. The migraine became debilitating on Sunday, January 3, 2021. I had vomiting, nausea and dizziness as well. I was unable to work on Monday, January 4, 2021 because I still had the migraine. I take Ubrelvy (prn) and it did not work. I attempted to return to work Tuesday afternoon as the migraine subsided, but it returned shortly after I made it to work. Our treatment nurse took my blood pressure, it was high. My blood sugar was high. I was dehydrated and the migraine was back. My nurse practitioner treated me with an IV of saline solution, pain relieving injection for the migraine and Zofran for the nausea.
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| 50 | 2021-01-28 | nausea |
This writer did not administer vaccine. Pt received vaccine at clinic and reported feeling shaky and...
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This writer did not administer vaccine. Pt received vaccine at clinic and reported feeling shaky and nausea . Denies sob chest pain headache feeling dizzy or lightheaded. No respiratory distress
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| 50 | 2021-01-29 | difficulty swallowing |
Patient received COVID vaccine at 10:45 while in patient observation they began to have hives so a B...
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Patient received COVID vaccine at 10:45 while in patient observation they began to have hives so a Benadryl was given at 10:50 and was held for further observation. While waiting the patient began to have difficulty breathing, swallowing and was short of breath at 11:07 and 911 was called immediately and an epipen was given. The firemen came to the location to assess the patient and paramedics shortly came after to take the patient to Kaiser Fontana.
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| 50 | 2021-01-30 | abdominal pain |
Noticed bloody urine in toilet at approximately 3PM, 4PM, and 9PM on Friday 1/29/2021. Awoke Saturd...
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Noticed bloody urine in toilet at approximately 3PM, 4PM, and 9PM on Friday 1/29/2021. Awoke Saturday morning to severe abdominal pain and extreme bloody urine.
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| 50 | 2021-01-30 | nausea, retching |
Woke up at 3 am with body aches-got up to take ibuprofen. When I was heading back to bed, my husband...
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Woke up at 3 am with body aches-got up to take ibuprofen. When I was heading back to bed, my husband heard a loud thud and found me laying on the floor beside the bed, passed out. He rushed over to me and called my name several times before I became conscious. He estimates it was a span of about 30 seconds. When I awoke, I immediately began to cold sweat and dry heave several times. Then I became cold and was shivering. My husband then transported me to the hospital emergency room. I received a cardiac test, which they said was good. I also received intravenous fluids and medication to treat pain and nausea. They drew labs which they said looked normal and did an X-ray my right shoulder because I struck my head and shoulder on a night stand when I passed out. They released me about an hour later after having me stand and walk to ensure my blood pressure did not drop, causing me to feel faint again. They sent me home with a prescription for Zofran to help with any further nausea, advised me to take ibuprofen for head and shoulder pain and body aches and advised rest. They also said to return if any other incidents occur and to follow up with my family doctor if symptoms persist.
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| 50 | 2021-01-31 | diarrhea |
Arm soreness; Aches; Exhaustion; Diarrhea; This is a spontaneous report from a contactable consumer ...
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Arm soreness; Aches; Exhaustion; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 15Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included drug allergy to Quinolones, asthma and thyroid cancer from an unknown date and unknown if ongoing. Concomitant medication included omeprazole, levothyroxine sodium (SYNTHROID), topiramate (TOPAMAX) and sertraline hydrochloride (ZOLOFT). The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Jan2021 02:00 PM, the patient experienced arm soreness, aches, exhaustion, diarrhea. No treatment was received for the events. The outcome of the events was recovering. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect.
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| 50 | 2021-01-31 | diarrhea, decreased appetite |
I became increasingly sick within 24 hours after the shot. I was very tired, felt feverish, very col...
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I became increasingly sick within 24 hours after the shot. I was very tired, felt feverish, very cold, coughing, headache and diarrhea. 36 hours after the shot I began to notice a loss of taste and smell. 48 hours I was very weak and needed to sleep for the next 3 days. Overall loss of appetite, diarrhea and very bad cough continued for at least 1 week.
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| 50 | 2021-01-31 | indigestion |
NOT FEELING MY NORMAL SELF, HEARTBURN, HOT IN ABDOMINAL, TEMP99, ANIXETY, DIZZY SPELLS, AWKWARD FEEL...
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NOT FEELING MY NORMAL SELF, HEARTBURN, HOT IN ABDOMINAL, TEMP99, ANIXETY, DIZZY SPELLS, AWKWARD FEELING IN MY HEAD, EXTREAMLY WEAK, THE 1ST DAY NOT SO BAD BUT DAY2-6 MUCH WORSE DAYS 7 &8 GETTING BETTER DAY 9 BACK TO NORMAL SELF.
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| 50 | 2021-02-01 | diarrhea |
Around 6 hrs after vaccine felt fatigue. I also exp tenderness at injection site and 9 days shortnes...
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Around 6 hrs after vaccine felt fatigue. I also exp tenderness at injection site and 9 days shortness of breath with diarrhea/mild headache.I went to urgent care for Covid, PCR test (results negative). I had symptoms approximately 10 days before shortness of breath resolved.
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| 50 | 2021-02-01 | vomiting, diarrhea, abdominal discomfort |
diarrhea; vomiting; Upset stomach; This is a spontaneous report from a contactable consumer (patient...
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diarrhea; vomiting; Upset stomach; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: ELO142), via an unspecified route of administration on 15Jan2021 13:00 at a single dose in left arm for COVID-19 immunization. Medical history included Hodgkin lymphoma, thyroid cancer, breast cancer and hypothyroidism, known allergies: allopurinol. There was no other vaccine in four weeks. Concomitant medications: There was other medications in two weeks, but unspecified. The patient experienced upset stomach about 2 hours after vaccination was administered (15Jan2021 15:00), then diarrhea and vomiting both on 16Jan2021 15:00 (as reported) (about 14 hours after vaccine was given). No treatment received. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No COVID prior vaccination and no COVID tested post vaccination. The outcome of events was recovered on an unspecified date in Jan2021.
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| 50 | 2021-02-03 | vomiting, nausea |
Client received vaccine at 1:25 pm. After approximately 15 minutes client reported feeling nausea....
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Client received vaccine at 1:25 pm. After approximately 15 minutes client reported feeling nausea. Instructed to stay for an additional 15 minutes for extended observation. Approximately 25 minutes after vaccination client feeling faint and described feeling of acid reflux, difficulty recognizing people and disoriented. Also pale, not clammy. assisted to supine position. EMTs onsite and doctor notified. Nausea continued. Vomited x 2. After approximately 60 minutes client was able to sit up. Spouse arrived and accompanied patient out of the building. Patient ambulated with limited assistance by her husband. Husband given recommendations on follow-up, if needed.
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| 50 | 2021-02-03 | nausea |
Headaches; pain/extreme body aches (worse than my fibromyalgia); a little difficulty to breath; extr...
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Headaches; pain/extreme body aches (worse than my fibromyalgia); a little difficulty to breath; extreme tiredness; swelling; woke up with my face swollen it went down after hot shower; Nauseous throughout the day; eyes burning; cold sores on my mouth; This is a spontaneous report from a contactable health care professional nurse, the patient. A 50-year-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248), in the right arm on 19Jan2021 13:15 as a single dose, for COVID-19 vaccination. The vaccine was administered at a Public Health Clinic facility. Medical history included asthma, Fibromyalgia and known drug allergy to penicillin. Concomitant medication included diclofenac (DICLOFENAC), clonazepam (KLONOPIN). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 20:00, the patient experienced pain started at exactly 8:00pm; extreme body aches (worse than my fibromyalgia), a little difficulty to breath, extreme tiredness, swelling, woke up with my face swollen (it went down after hot shower). Nauseous throughout the day, eyes burning and cold sores on my mouth and Headaches. No treatment was received given for the event. The clinical outcome of pain, extreme body aches, difficulty to breath, extreme tiredness, swelling, face swollen, nauseous, eyes burning, cold sores on mouth and Headaches were recovering.
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| 50 | 2021-02-03 | nausea |
Next morning splitting headache woke me up at 5 am. Took Advil. 3 hours later still headache w/nause...
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Next morning splitting headache woke me up at 5 am. Took Advil. 3 hours later still headache w/nausea.; Next morning splitting headache woke me up at 5 am. Took Advil. 3 hours later still headache w/nausea.; 3 hours later woke up with sweats.; Few hours after dose fatigue.; In the evening, leg weakness and achy all over.; In the evening, leg weakness and achy all over.; This is a spontaneous report from a contactable nurse (patient). This 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 16Jan2021 09:15 AM at single dose for covid-19 immunisation. Medical history was unknown. Concomitant medications were none. The patient experienced few hours after dose fatigue at 02:00 PM on 16Jan2021. In the evening of 16Jan2021, the patient had leg weakness and achy all over. Next morning on 17Jan2021, splitting headache woke the patient up at 5 am. The patient took Advil as treatment for headache. 3 hours later the patient still had headache with nausea. 3 hours later she woke up with sweats. Then she started feeling better. The patient woke up this morning slight headache only and resolved on own couple hours later. No treatment was received for the events except headache. The patient had no other vaccine in four weeks or other medications in two weeks. The patient had no covid tested post vaccination, no known allergies. Outcome of all events was recovered. Information on the lot/batch number has been requested.
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| 50 | 2021-02-03 | nausea |
Patient here for her 2nd Pfizer vaccine. Immediately after she got it, she began to have moderate/...
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Patient here for her 2nd Pfizer vaccine. Immediately after she got it, she began to have moderate/severe nausea. She is also having light headedness. Her vitals are 136/90, P-98, O2- 98 @ 1447. She denies history of vaccine allergic reactions. Her only reaction from 1st injection was a sore arm. Her baseline vitals are 121/?, P-60-70. @1452 vitals are 134/88, P-122, o2-99. No meds have been given. Patient given ice pack for neck and reclined in reclining chair. Dr. consulted. Vitals @ 1510 130/70, P-106, 24 resp. Dr. advised further monitoring for the mean time. TC to patient's manager, that patient is having reaction to vaccine and is being monitored and will be delayed in returning to dept. Manager verbalized understanding and appreciation. (Created on 2/04/2021 and 3:42pm) Vitals @ 1553 147/80, P-98. Patient reported that nausea is still the same but that her throat started feeling funny. 50mg Benadryl IM given in Right Deltoid by RN @1600. Dr. informed. Director and AD also informed of situation. Patient's manager called by RN to give update on patient and to request that someone in dept bring patient's handbag. (Created on 2/04/2021 and 4:21pm) Vitals @ 1620 139/86, P-86, O2-97, Resp- 28. Patient reports that strange feeling in throat is improving. Nausea & light headedness is the same. She said that she had been feeling hot earlier but not anymore. Updated Dr. on patient's status. Asked Dr. if she may be released to go home with her aunt who is picking her up at 5pm if patient is stable and her vitals are stable. Dr. stated that patient may be released with a Benadryl tablet to go. (Created on 2/04/2021 and 4:43pm) Vitals @ 1720 163/96, P-114, O2-100 Called IMT to PFW 4. Patient initially refused to be taken to ER. Noticed that patient was having labored breathing. Vitals @ 1739 162/91, P-124. After IMT team spoke with patient about vitals, patient decided to go to ER. Patient was taken in wheelchair by IMT team@ 1745.
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| 50 | 2021-02-03 | difficulty swallowing |
Pt. states that around 1600 pm on 2/3/21 she started having difficulty swallowing along with feeling...
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Pt. states that around 1600 pm on 2/3/21 she started having difficulty swallowing along with feeling her heart beat fast. Pt. states that she went to ER where she was given an epi pen and steroids and observed for a few hours before being discharged from the er to follow up with her pcp. Pt. states that today she is feeling much better and is able to swallow.
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| 50 | 2021-02-03 | appendicitis, abdominal pain |
Three weeks post vaccine I developed severe diffuse abdominal pain sending me to the emergency room....
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Three weeks post vaccine I developed severe diffuse abdominal pain sending me to the emergency room. Work up revealed acute appendicitis and I was scheduled for emergency laparoscopic appendectomy the following day.
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| 50 | 2021-02-03 | difficulty swallowing |
perioral numbness with HA; perioral numbness with HA; Difficulty swallowing & breathing; Difficulty ...
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perioral numbness with HA; perioral numbness with HA; Difficulty swallowing & breathing; Difficulty swallowing & breathing; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiration date not provided), intramuscular in the left arm on 23Dec2020 09:45 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergies to garlic. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium. The patient previously took sulfamethoxazole trimethoprim (BACTRIM) and experienced allergies. On 23Dec2020 09:45, the patient experienced perioral numbness with HA, Difficulty swallowing and breathing. The patient felt it was likely due to the N95 mask. She was given procedural mask and reported improvement of symptoms. A Rapid response was contacted. No other intervention was done. Treatment was not provided in response to the events. The outcome of the events was recovered on an unspecified date. The patient has not tested for COVID post vaccination.
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| 50 | 2021-02-04 | abdominal discomfort, nausea, diarrhea |
Diarrhea; upset stomach; nausea; fatigue; fever; This is a spontaneous report from a contactable pha...
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Diarrhea; upset stomach; nausea; fatigue; fever; This is a spontaneous report from a contactable pharmacist, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: El3248), via an unspecified route of administration in the left arm on 19Jan2021 at 10:45 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none; the patient had no known allergies. The patient was not diagnosed with COVID prior to the vaccination. Concomitant medications included unspecified multivitamins. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Ek5730) on 30Dec2020 at 10:30 (at the age of 50-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccinations within 4 weeks of the vaccination. On 19Jan2021 at 16:00, the patient experienced diarrhea, upset stomach, nausea, fatigue and fever. The patient did not receive treatment for the events. Since the vaccination, the patient was not tested for COVID. The clinical outcome of diarrhea, upset stomach, nausea, fatigue and fever was resolving.
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| 50 | 2021-02-04 | nausea, vomiting |
Within 4-5 hours, muscle soreness on shoulder at injection site. Within 12-13 hours, migraine, feve...
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Within 4-5 hours, muscle soreness on shoulder at injection site. Within 12-13 hours, migraine, fever, chills, body aches, nausea, and vomiting. Symptoms lasted 36-38 hours from the time of vaccination
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| 50 | 2021-02-05 | nausea, vomiting |
2/5/2021 @ 1:00 AM vomited X2, chills, body aches, fever 100.6, HA, fatigue, watery eyes, weakness, ...
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2/5/2021 @ 1:00 AM vomited X2, chills, body aches, fever 100.6, HA, fatigue, watery eyes, weakness, sweating, and nausea for 30 hours. Feel weak and tired now.
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| 50 | 2021-02-05 | diarrhea |
Several symptoms - achy, chills, low grade fever - present 2/5/2021 loose bowels, sore arm - presen...
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Several symptoms - achy, chills, low grade fever - present 2/5/2021 loose bowels, sore arm - present 2/5/2021 and still present 2/6/2021
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| 50 | 2021-02-07 | diarrhea |
1. RECIEVED BOTH DOSES OF COVID VACCINE ON 01/08/21 & 01/28/21 2. HAD NEGATIVE RAPID COVID ON 02/04/...
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1. RECIEVED BOTH DOSES OF COVID VACCINE ON 01/08/21 & 01/28/21 2. HAD NEGATIVE RAPID COVID ON 02/04/21 AND NEGATIVE COVID PCR ON 02/05/21. 2. HAD HIGH RISK EXPOSURE TO COVID + PERSON ON 01/31/21 & 02/08/21AERZ 3. ICC VISIT FOR FOLLOWING SYMPTOMS: CHILLS, HEADACHE, SORE THROAT, COUGH, SHORTNESS OF BREATH, AND DIARRHEA X1 DAY. 4. TESTED NEGATIVE RAPID COVID ON 02/08/21.
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| 50 | 2021-02-07 | abdominal pain upper |
Shivering uncontrollably; Fever; Heart rate was erratic; dysautonomia; High heart rate; patient rece...
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Shivering uncontrollably; Fever; Heart rate was erratic; dysautonomia; High heart rate; patient received bnt162b2 with concomitant medication prednisone; patient received bnt162b2 with concomitant medication prednisone; Stomach ache; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 11:00 am at single dose at left arm for COVID-19 immunisation. Medical history included penicillin allergy, nonspecific myositis, small fiber neuropathy, stroke, neurogenic orthostatic hypotension, hypermobile EDS, osteoarthritis, osteoporosis, Raynauds, esophageal dysmotility from an unknown date. Concomitant medications within 2 weeks of vaccination included fexofenadine hydrochloride (ALLEGRA), gabapentin, prednisone (PREDNISON), tramadol. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On same day after vaccination on 21Jan2021, patient had bad stomach ache. Woke up next day shivering uncontrollably, fever of 102 on 22Jan2021 07:45 am. Also heart rate was erratic (patient had dysautonomia) - 140 then dropped to 53 then back up to 123 all in same minute. This happened repeatedly and maintaining high heart rate. Patient didn't receive treatment for events. The adverse events resulted in emergency room/department or urgent care. Outcome of above events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The report was considered as non-serious. Information on the lot/batch number has been requested.
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| 50 | 2021-02-08 | vomiting, nausea |
Received vaccine on 12/29/2020 around 11:15am. Approximately 7 hours later, developed left arm pain ...
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Received vaccine on 12/29/2020 around 11:15am. Approximately 7 hours later, developed left arm pain and left neck pain. 12/30 developed a small headache that progressed into a severe headache with nausea and vomiting. Went to ED on 12/30 at 12:04pm and discharged at 15:55. Received 0.9 % sodium chloride 999 mL, ondansetron 4 mg, CBC And Differential (Abnormal), Comprehensive Metabolic Panel (Abnormal), Lipase, acetaminophen 650 mg, SARS-CoV-2 NAT, IP UA w/Microscopic, Reflex Culture (Abnormal). Instructed to take ondansetron-ODT 4 mg disintegrating tablet by mouth every 8 (eight) hours as needed for nausea.
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| 50 | 2021-02-09 | decreased appetite |
no appetite; chills; cough; fatigue; shortness of breath; This is a spontaneous report from a contac...
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no appetite; chills; cough; fatigue; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chills, cough, fatigue, shortness of breath, no appetite on 02Jan2021. The events resulted in: Doctor or other healthcare professional office/clinic visit. Event treatment included antibody IgG. Covid was tested post vaccination in Jan2021 with unknown result. The outcome of the events was recovering. Information on Lot/batch number has been requested.
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| 50 | 2021-02-17 | vomiting, nausea |
6 hrs post vax and 48 hours post vax: injection site pain; 6 hrs post vax: headache/ 48 hours post ...
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6 hrs post vax and 48 hours post vax: injection site pain; 6 hrs post vax: headache/ 48 hours post vax: remaining symptoms headache; 24 hours post vax: as above plus extreme fatigue/ 48 hours post vax: extreme fatigue; 24 hours post vax: chills/inability to feel warm; 24 hours post vax: inability to feel warm; 28 hours post vax: hot and cold flashes/ 48 hours post vax: remaining symptoms hot and cold flashes; 28 hours post vax: as the above plus nausea; 32 hours post vax: as above plus vomiting/ 38 hours post vax: vomiting ended; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 48 hours post vax: general physical weakness and malaise; 48 hours post vax: general physical weakness and malaise; This is a spontaneous report from a contactable other Health professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9261), via an unspecified route of administration on 28Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Workplace clinic. Age at vaccination was 50-years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0142) administered on 07Jan2021 (at the age of 50 years), at single dose in left arm. Medical history included anxiety, depression, obesity. The patient has allergies to certain unspecified antibiotics. Concomitant medications included citalopram, linum usitatissimum seed oil (FLAX SEED OIL), daily multivitamin 50+. It was reported that 6 hrs post vax on 29Jan2021 the patient experienced injection site pain, headache, 24 hours post vax: as above plus extreme fatigue, chills/inability to feel warm, 28 hours post vax: as the above plus nausea, hot and cold flashes, 32 hours post vax: as above plus vomiting, 38 hours post vax: vomiting ended, otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body, 48 hours post vax: remaining symptoms headache, injection site pain, hot and cold flashes, ex-treme fatigue, general physical weakness and malaise. The events were reported as non serious. No treatment was received for the events. The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
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| 50 | 2021-02-17 | vomiting |
Vomited once morning; feeling unwell/general feeling of not feeling well; low grade fever/102.4 temp...
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Vomited once morning; feeling unwell/general feeling of not feeling well; low grade fever/102.4 temperature; chills; intense headache; whole body aches; This is a spontaneous report from a contactable nurse. A 50-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date unknown), via an unspecified route of administration on left arm on 28Jan2021 at 10:45 at a single dose for COVID-19 immunisation at the doctor's office/ urgent care. Medical history included Complex post traumatic stress (cPTSD) and high blood pressure related to cPTSD. Allergies to medications, food, or other products was none. Concomitant medications included colecalciferol (VIT D3), duloxetine hydrochloride (CYMBALTA), losartan, buspirone and multi-vitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on left arm on 06Jan2021 at 11:15 AM for COVID-19 immunization. On 28Jan2021, 22:30, patient began feeling unwell so orally checked temperature noting a low grade fever. Overnight and until morning on 30Jan2021. The patient also experience chills, 102.4 temperature, intense headache, whole body aches on 28Jan2021 at 22:30.. Vomited once morning of 29Jan2021. Began taking Tylenol at 8pm on 29Jan2021 until fever seemed to end midday on 30Jan2021, to get relief. On 31Jan2021 still experiencing headache, whole body aches and general feeling of not feeling well. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No treatment received for the events not feeling well, chills, intense headache, whole body aches, and vomited once morning. The patient has not recovered from the events.
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| 50 | 2021-02-21 | vomiting, nausea |
Received the 2nd shot on 2/11/2021. I started feeling a little "off" later in the evening. I woke up...
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Received the 2nd shot on 2/11/2021. I started feeling a little "off" later in the evening. I woke up at 0300 with severe joint pain, headache and chills. Nausea started shortly afterwards. The joint pain was excruciating and it was very difficult to move. By 0330, I started vomiting. Vomiting continued until approximately 0745. I felt dehydrated but was not able to hold down any water. I contacted the Nurse Advice line and spoke to a nurse. She asked me a series of questions, all relating to signs indicative of an allergic reaction. I knew I was not experiencing a typical allergic reaction. But I was experiencing a bad reaction. Based on my responses to her questions, she did not recommend that I go an Urgent Care Clinic or see a Doctor. The severe joint pain continued through 02/14/2021. I started to feel better on 02/15/2021. Even though I did not experience an allergic reaction, given the severity of my joint pain and vomiting, I still feel it is important for what I did experience to be documented. Thank you.
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| 50 | 2021-02-22 | abdominal pain, diarrhea, nausea, vomiting |
Developed symptoms of COVID-19 and tested positive with PCR test for COVID-19 on 1-29-2021. Symptoms...
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Developed symptoms of COVID-19 and tested positive with PCR test for COVID-19 on 1-29-2021. Symptoms included cough, rhinorrhea, sore throat, sinus congestion, severe headache, weakness, body aches, N/V/D, fever, chills, night sweats, abdominal pain. Was quarantined for 10 days post symptom onset.
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| 50 | 2021-02-22 | nausea |
Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in gl...
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Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in glands under arm. Muscle spasms in arms and chest. Slight nausea.
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| 50 | 2021-02-24 | vomiting |
Started 2/15 with joint pain. On 2/20 started with high fever, chills and headache, frequent urinati...
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Started 2/15 with joint pain. On 2/20 started with high fever, chills and headache, frequent urination and dehydration. On 2/22 started to vomit continued with other systems. Went to emergency clinic. They thought it was a UTI and prescribed an antibiotic. Antibiotics not working. Admitted to hospital on 2/23. All above symptoms continues. Met with internal dr and infectious disease dr. They believe this is a bladder infection plus a virus. Have been in hospital for three days now. Dr ordered more labs and waiting on outcome.
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| 50 | 2021-02-24 | nausea | lightheadedness, nausea |
| 50 | 2021-02-25 | nausea |
Entire body aches terribly. extreme nausea and a headache not relieved by OTC medication. Full blo...
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Entire body aches terribly. extreme nausea and a headache not relieved by OTC medication. Full blown malaise.
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| 50 | 2021-02-26 | abdominal pain upper, nausea |
2/24/21 Injection Site arm soreness (8 hours) 2/25/21 - Right arm pain, nausea, body aches (12 hou...
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2/24/21 Injection Site arm soreness (8 hours) 2/25/21 - Right arm pain, nausea, body aches (12 hours) stomach pain (6 hours) Migraine-like headache (8 hours) 2/26/21 Tired 8 hours
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| 50 | 2021-02-26 | nausea |
Pt. c/o nausea and dizziness while sitting in Observation. EMT and MD evaluated patient. BP 178/10...
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Pt. c/o nausea and dizziness while sitting in Observation. EMT and MD evaluated patient. BP 178/101, 186/98 and 165/96 over a 10 minute period. SPO2 99%. Pt. has hx of HTN and reported taking her meds that am as Rx'd. Pt. released home with spouse and will follow up with PCP on Monday.
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| 50 | 2021-02-27 | nausea |
Intense chills for approximately 30 minutes; body aches, much like flu; headache and nausea. Advil...
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Intense chills for approximately 30 minutes; body aches, much like flu; headache and nausea. Advil eases body aches, rest helped. By early afternoon, I was much better.
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| 50 | 2021-02-27 | abdominal pain, vomiting | Severe abdominal pain and vomiting approximately 3 hours after injection |
| 50 | 2021-02-28 | difficulty swallowing, nausea |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: All...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
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| 50 | 2021-03-01 | nausea |
dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purp...
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dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purple on the center of it; My legs were hurting like really heavy; I have not gone back to sleep and I feel like a bus hit me.; chills; the body ache; legs hurt really bad; fever; symptoms associated with the flu for a few days; feeling like really bad headache; nauseated; not feel so good; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: unknown), via an unspecified route of administration from 28Jan2021 to 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. Concomitant medication included verapamil for blood pressure. The patient received her first dose of BNT162B2 on 08Jan2021 and experienced arms a little sore. On 28Jan2021 at 18:00, the patient started feeling like really bad headache and then really nauseated. The patient took medicine and took Tylenol before went in to take her shot and started getting a headache again and not feel so good. On 29Jan2021 at 02:00, the patient stated that her legs were hurting like really heavy and had not been back to sleep since 2 o clock in the morning and she felt like a bus hit her. On 29Jan2021 at 11:00, the patient stated that her finger on the left side was numb and it has a little bit of purple on the center of it. On 29Jan2021, the patient experienced chills, body ache, her legs hurt really bad, fever, symptoms associated with the flu for a few days. On 30Jan2021, the patient experienced arm swollen. On 01Feb2021, the patient experienced dizziness and migraine. The patient already took Tylenol and ibuprofen. The outcome of the event chills, fever, flu symptoms, arm swollen was recovered on an unspecified date and the outcome of the other events was unknown.
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| 50 | 2021-03-02 | diarrhea, nausea, vomiting |
Day after suffered low grade temperature, chills, nausea, vomiting, aches & pains, sore throat, head...
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Day after suffered low grade temperature, chills, nausea, vomiting, aches & pains, sore throat, headache, diarrhea. Duration of 3 days. Due to Covid protocol at healthcare facility where I work at I was taken off work until no fever was present without taking medication.
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| 50 | 2021-03-02 | nausea |
Injection site pain; Chills; nausea; fever 99.5; This is a spontaneous report from a contactable con...
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Injection site pain; Chills; nausea; fever 99.5; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right arm on 30Jan2021 10:00 at a single dose for COVID-19 immunization in a clinic. Medical history included high blood pressure and COVID-19 prior to vaccination. The patient was not pregnant. Concomitant medication included hydrochlorothiazide, lisinopril hydrochlorthiazid, loratadine, and fluticasone propionate (FLONASE). The patient experienced injection site pain, chills, nausea, fever 99.5 on 30Jan2021 10:00. The patient did not receive any treatment for the events. The patient was recovering from the events. Information on lot/ batch number has been requested.
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| 50 | 2021-03-02 | nausea |
dizzy; nauseas; This is a spontaneous report from a contactable consumer (patient). A 50-year-old no...
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dizzy; nauseas; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer COVID vaccine), lot no. EL1283, via an unspecified route of administration (vaccine location: left arm) on 27Jan2021 10:00 at a single dose for COVID-19 immunization at a public health clinic/administration facility. Medical history included Gerd and allergies to tetracycline. Concomitant medications included omeprazole, cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D), and unspecified multivitamins. No other vaccines in four weeks. No Covid prior vaccination. On 27Jan2021 10:00 AM (as reported), within 1 minute, the patient was dizzy and nauseas. The symptoms went away in10 minutes. No treatment for the events. She has not experienced any other side effects. No Covid test post vaccination. The outcome of the events was recovered on 27Jan2021 10:10.
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| 50 | 2021-03-03 | nausea, abdominal pain upper |
I experienced a stomach ache first, then feeling of nasuea, dizziness, severe sweating for approxima...
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I experienced a stomach ache first, then feeling of nasuea, dizziness, severe sweating for approximately 15 minutes on Feb 27th. The sx then went away except for the stomach aches for a few hours afterwards. Yesterday and today I have experienced feelings of lethargy, fogginess, stomach ache, sore throat, stomach ache and nasal congestion which have faded in an out throughout the day.
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| 50 | 2021-03-03 | nausea |
nausea, hot flashes, aches, blood pressure drops and spikes, low oxygen, dizziness symptoms subsided...
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nausea, hot flashes, aches, blood pressure drops and spikes, low oxygen, dizziness symptoms subsided with antihistamine lasted 2 hours
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| 50 | 2021-03-09 | diarrhea |
joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection s...
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joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection site pain; malaise; muscle cramping; swollen lymph nodes; projectile vomiting; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration in right arm on 03Feb2021 15:45 at single dose for covid-19 immunisation. Medical history included diabetes, hypertension (HTN), and gastrooesophageal reflux disease (GERD). Known allergies included xylometazoline hydrochloride (SUDAFED). Concomitant medication included omeprazole (PROTONIX), metformin hydrochloride, sitagliptin (JANUMET), empagliflozin (JARDIANCE), insulin glargine (BASAGLAR), escitalopram oxalate (LEXAPRO). There was no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient experienced joint pain, weakness, chills, diarrhea, dizziness, minor difficulty breathing, headache, injection site pain, malaise, muscle cramping, swollen lymph nodes, projectile vomiting, all on 04Feb2021 09:15 with outcome of recovering. No treatment received for the events.
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| 50 | 2021-03-21 | nausea, vomiting |
Presented to ED on 3/10/21 for migraine and discharged home. Reported only sore arm following vaccin...
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Presented to ED on 3/10/21 for migraine and discharged home. Reported only sore arm following vaccination. Presented to ED on 3/7/21 with back pain, no COVID symptoms reported and was discharged home. Presented to ED on 3/10/21 with generalized body aches, nausea, vomiting, and headache for 2 days. Noted mild cough and sinus congestion and was admitted to hospital for 5 days until 3/14/21. Returned to ED on 3/15/21 with worsening shortness of breath and was admitted to hospital for another 5 days until 3/19/21.
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| 50 | 2021-03-24 | abdominal discomfort |
Very tired; A little upset stomach; Neuropathy returned in my hands, feet and lower legs; Neuropathy...
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Very tired; A little upset stomach; Neuropathy returned in my hands, feet and lower legs; Neuropathy returned in my hands, feet and lower legs; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (BNT162B2, Lot number: EN6199; Expiration date was not reported) on the left arm on 04Mar2021 (16:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the public health clinic. Medical history included rectal cancer from 2018 to an unspecified date; chemo from 2019 to an unspecified date; and neuropathy that was left from the chemotherapy. The patient had unspecified concomitant medications. The patient previously took aspirin (acetylsalicylic acid), and had drug allergy. The patient was not pregnant at the time of vaccination. On 04Mar2021 (17:30), the patient's neuropathy had returned in the hands, feet and lower legs; and had sore arm. On 05Mar2021 (10:30), the patient was very tired, and had a little upset stomach. The patient did not receive treatment for the events. The outcome of the events, 'neuropathy had returned in the hands, feet and lower legs', 'sore arm', 'very tired' and 'little upset stomach', was recovering. The patient has not had COVID-19 prior to vaccination; and was not tested for COVID-19 post-vaccination.
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| 50 | 2021-03-28 | decreased appetite |
couldn't breathe or drive; heart throbbing in chest for a few minutes - very scary; front right rib ...
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couldn't breathe or drive; heart throbbing in chest for a few minutes - very scary; front right rib popped out; lack of appetite; swelling at back of neck/ entire upper body swelled up; intestines gurgling; headache/severe headache; Swelling in rib cage, collar bone; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9261, expiration date was unknown), via an unspecified route of administration, administered in the left arm on 12Feb2021 at 12:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as the public health clinic/facility. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiration date was unknown) on 22Jan2021 at 12:00 PM in the left arm at the age of 50 years, for COVID-19 immunization. Relevant medical history included Graves' disease from an unknown date and unknown if ongoing and had her thyroid removed on an unspecified date. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) for Graves' disease as she had her thyroid removed; levothyroxine sodium (SYNTHROID) for Graves' disease as she had her thyroid removed; and doxycycline taken for an unspecified indication; all start and stop date were not reported. The patient previously took codeine and had known allergy to this drug. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. The patient was not tested for Covid post vaccination. On 27Feb2021 at 06:00, the patient experienced swelling at back of neck, intestines gurgling, and headache. On 28Feb2021, the patient's entire upper body swelled up and her front right rib popped out; she had severe headache, lack of appetite, and slept sitting straight up as she could not put pressure on spine or lay down. On 01Mar2021, the patient's spouse took the patient to a chiropractor to adjust rib as she couldn't breathe or drive. Six (6) hours later on 01Mar2021, the patient experienced heart throbbing in chest for a few minutes - very scary. Swelling in rib cage, collar bone from an unspecified date in on Feb2021, and neck were subsiding by 11 pm. On 03Mar2021, the patient had her second chiropractic (chiro) visit to adjust neck. On 13Mar2021, gastronol was given for gurgling and the patient still had no appetite. The swelling was all better. The patient would need to go to the chiropractor about four more times to keep adjusting rib back in place. The adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events, which included chiropractic care for rib adjustment and gastronol. The patient recovered from the events "swelling at back of neck/ entire upper body swelled up and swelling in rib cage, collar bone" on an unspecified date, while the patient was not recovered from the rest of the events.
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| 50 | 2021-03-28 | nausea |
shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in...
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shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in my right arm, less than five minutes. I felt a flush go down my left arm; shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in my right arm, less than five minutes. I felt a flush go down my left arm; got extreme pain all the way down to the tips of my fingers; slight tingling in the fingertips; could not move my arm; nausea; dizziness; bone pain in arms and legs; exhaustion; My arm still hurts; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 50-years-old, administered in Arm Right on 05Mar2021 11:00 (Lot Number: EN6205) as single dose for COVID-19 immunization. Medical history included allergies to walnuts. The patient was not pregnant. The patient's concomitant medication included High blood pressure medication. The patient previously took Niacin and experienced allergies. The patient reported, "shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in my right arm, less than five minutes. I felt a flush go down my left arm, starting at the top of my shoulder down to my hand and got extreme pain all the way down to the tips of my fingers with slight tingling in the fingertips. I could not move my arm, blood pressure shot up to 200 then it was 192/121 and so on I was monitored at the hospital for a couple of hours with no change or help. I went home and monitored for 29 hours it stayed elevated in the upper hundreds, spiking lowering down a few to 174/124 and spiking back up I got the vaccine on Friday at 11:00 AM my blood pressure did not break until Saturday around 3:00 p.m. I got other side effects, nausea, dizziness, bone pain in arms and legs, exhaustion but the blood pressure scared me the most. My arm still hurts to this day 12Mar2021. I was evaluated but not given anything to bring it down." The adverse events started on 05Mar2021 11:00 AM. The events resulted in Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization). No treatment for adverse events were received. The patient underwent lab tests and procedures which included blood pressure measurement: high, up to 200 then it was 192/121 on 05Mar2021 spiking lowering down a few to 174/124 on Mar2021. The patient recovered with lasting effects. Facility type vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
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| 50 | 2021-04-07 | diarrhea, abdominal pain upper, vomiting |
Syncope; Vomiting; uncontrollable water diarrhea for almost 12 hours.; Severe stomachache; intestina...
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Syncope; Vomiting; uncontrollable water diarrhea for almost 12 hours.; Severe stomachache; intestinal cramping; Low grade fever; Chills; Sweats; This is a spontaneous report from a non-contactable consumer (patient). A 50-years-old female, non-pregnant, patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine at pharmacy or drug store via an unspecified route of administration, administered in left arm on 19Mar2021, at 50 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included fibromyalgia from an unknown date. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included nifedipine, clonazepam, estradiol and propranolol, all taken for an unspecified indication, start and stop date were not reported. In Mar2021 the patient experienced syncope, assessed as medically significant, vomiting, uncontrollable water diarrhea for almost 12 hours, severe stomachache, intestinal cramping, low grade fever, chills and sweats. No treatment was received for the events. All the events were resolving at the time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 50 | 2021-04-12 | vomiting | Blood clot, stroke, severe headaches, dizziness, vomiting |
| 50 | 2021-04-13 | vomiting, nausea |
The patient is a 50 year old female with no medical problems who developed sudden severe headache on...
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The patient is a 50 year old female with no medical problems who developed sudden severe headache on 3/24 accompanied by nausea and vomiting. She presented to urgent care on 3/25 and was considered to be dehydrated and given IV fluids. On 3/27 she developed left hand weakness. On 3/29 she revisited urgent care with residual symptoms plus hand weakness and was sent to hospital where she was admitted and MRV demonstrated Cerebral Venous Sinus Thrombosis of the sagittal sinus, right transverse sinus, and right sigmoid sinus. The left transverse sinus may also be occluded or congenitally absent. There was no evidence of hemorrhage or stroke. The patient was admitted and started on heparin then transitioned to Eliquis and discharged. On 4/3, she had worsening of symptoms consisting of dysarthria, left facial, and worse left arm and hand weakness. She was readmitted to hospital then transferred to hospital for further management.
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| 50 | 2021-04-14 | abdominal discomfort, retching |
blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, sho...
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blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, shortness of breath, extreme blood pressure immediately upon injection for 1 hour. Continued reactions 48 hours, extreme fatigue, blood pressure, dizziness, metal and bitter taste in the mouth, migraine, stomach upset, red polka dots on hands, itchiness underarms, cough, sore throat, and fever
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| 50 | 2021-04-26 | nausea |
fainted; slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); nause...
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fainted; slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); nausea/mild queasiness; dizziness; heat; slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); slight fever/mild queasiness; slammed my face on the bathroom floor; This is a spontaneous report from a contactable consumer, the patient. This 50 year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8733), dose 1 , single dose via an unspecified route of administration in the left arm on 31Mar2021 at 02:30 PM (at the age of 50 years-old) for COVID-19 vaccination. Medical history included Grave's disease under control with medication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included desogestrel, ethinylestradiol (KARIVA), methimazole, lansoprazole and atorvastatin. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 01Apr2021 at 12: 30 AM, 10 hours after vaccination administration, the patient experienced a sudden wave of severe nausea, dizziness, and heat and fainted. She slammed her face on the bathroom floor and broke her nose (among other cuts & bruises). Afterwards, her only symptoms were fainting injuries, slight fever/mild queasiness for 2 days. The events required a doctor or other healthcare professional office/clinic visit. Laboratory tests included a nose X-ray. Treatment was received for nausea, dizziness, heat and fainted, fever, slammed face, broke her nose (among other cuts & bruises). The clinical outcome of nausea, dizziness, heat and fainted, fever, slammed face, broke her nose (among other cuts & bruises) was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 50 | 2021-04-27 | abdominal pain upper, diarrhea |
This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0151; Expiration date was not reported) on the left arm on 06Apr2021 (15:00) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included neuroendocrine lung cancer, asthma, and allergies to shellfish and IV contrast dye. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7534; Expiration date was not reported) on 15Mar2021 (when the patient was 50 years old) for COVID-19 immunization. On 11Apr2021 (03:00), the patient had rectal bleeding, stomach cramps and diarrhea. The events were assessed as serious (medically significant), and had resulted into an emergency room/department or urgent care. The patient had received unspecified intravenous (IV) fluids as treatment for the reported events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.
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| 51 | 2021-01-01 | nausea |
Lots of dizziness and nausea. Even after a long nights rest, the dizziness does not go away. The diz...
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Lots of dizziness and nausea. Even after a long nights rest, the dizziness does not go away. The dizziness began the day of vaccine around 8pm and has not subsided.
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| 51 | 2021-01-03 | diarrhea |
Diarrhea persisted 24 hours with mucous and bloody mucous after all fecal material was exhausted.; D...
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Diarrhea persisted 24 hours with mucous and bloody mucous after all fecal material was exhausted.; Did have one episode of chills; This is a spontaneous report from a contactable physician. A 51-year-old female patient received the first dose of bnt162b2 (BNT162B2) lot no: EK9231, intramuscular on 23Dec2020 09:45 at a single dose for COVID-19 immunization in workplace clinic. Medical history included hypothyroid, allergies from bee sting, and covid-19 from Apr2020, all unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not receive other vaccine in four weeks. On 25Dec2020, in the late evening at 11:45 PM-almost midnight, the patient experienced diarrhea, severe, without nausea or vomiting. Did have one episode of chills that resolved. Diarrhea persisted 24 hours with mucous and bloody mucous after all fecal material was exhausted. The patient had COVID-19 in Apr2020 and had positive antibodies in Jun2020 with high titers. She confirmed with their ID chief that she should proceed to receive the vaccine. Diarrhea resolved in 24 hours. Some lingering increased GI activity. No fever (temp 99.0F) (Dec2020). The patient recovered from events without treatment in Dec2020. The events were reported as non-serious. The patient was not tested for COVID-19 post vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of diarrhea, severe cannot be excluded, considering the plausible temporal relationship and the known adverse profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 51 | 2021-01-03 | diarrhea |
Staff member at nursing home vaccinated at mass vaccination event on 12/18/2020 for residents and st...
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Staff member at nursing home vaccinated at mass vaccination event on 12/18/2020 for residents and staff. Developed headache, chills, diarrhea- muscle aches, joint aches on 12/29/2020 and tested positive for COVID-19 on 12/30/2020. Uneventful course isolating at home.
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| 51 | 2021-01-04 | vomiting, nausea | Headache, Anaphylaxis, UrticariaPruritus & NauseaVomiting |
| 51 | 2021-01-04 | nausea |
Migraines for several days, nausea on day three; nausea; This is a spontaneous report from a contact...
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Migraines for several days, nausea on day three; nausea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL0140), via intramuscular route of administration in the left arm on 18Dec2020 at 09:00 (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history included fibromyalgia and history of migraines. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 21Dec2020 at 13:00 the patient experienced migraines for several days, nausea on day three. The patient did not receive any treatment for the events. The clinical outcome of the migraines for several days, nausea on day three was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-01-04 | nausea |
Mild headache within first hour relieved some with Tylenol. 12 hours after injection, awoke to sever...
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Mild headache within first hour relieved some with Tylenol. 12 hours after injection, awoke to severe headache, and nausea; Mild headache within first hour relieved some with Tylenol. 12 hours after injection, awoke to severe headache, and nausea; This is a spontaneous report from a contactable nurse (patient herself). This 51-year-old female nurse received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 28Dec2020 at 16:00 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant. Relevant medical history included type 2 diabetes. No known allergies. Relevant concomitant medications included metformin, pravastatin and paracetamol (TYLENOL). The patient was vaccinated at hospital, age at vaccination was 51-year-old. No other vaccine was received in four weeks. Post-vaccination COVID test was not performed On 28Dec2020 at 17:00, the patient had mild headache within first hour relieved some with paracetamol (TYLENOL). 12 hours after injection, awoke to severe headache, and nausea. Unrelieved with TYLENOL after one hour. She took ibuprofen, 'CLARITIN' and ondansetron hydrochloride (ZOFRAN). Eventually relieved 1.5 hr after that. The patient recovered from both events in Dec2020.
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| 51 | 2021-01-04 | nausea |
waves of nausea for 2 days after; Dizziness; headache; difficulty with higher thought processes - fe...
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waves of nausea for 2 days after; Dizziness; headache; difficulty with higher thought processes - feeling "zoned out"; difficulty with higher thought processes - feeling "zoned out"; This is a spontaneous report from a contactable other healthcare professional (patient). A 51-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number unknown due to not available/provided to reporter at the time of report completion), intramuscular at left arm on 23Dec2020 09:00 at single dose for COVID-19 immunization at a "Nursing Home/Senior Living Facility". The patient's medical history included Gluten and FODMAP food allergy. Concomitant medications received within 2 weeks of vaccination: dietary supplements. No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested for COVID-19 post the vaccination. COVID-19 test post vaccination on 23Dec2020 result was negative. It was reported that on 23Dec2020 09:30, the patient experienced dizziness, headache, difficulty with higher thought processes - feeling "zoned out", and "waves of nausea for 2 days after". No treatment was taken for the above events. The outcome of the events was recovered in Dec2020. Information on the lot/batch number has been requested.
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| 51 | 2021-01-05 | diarrhea, nausea, decreased appetite |
Gastro problems, diaherra , muscle aches, my whole body hurts, nausea, headache, very very tired...I...
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Gastro problems, diaherra , muscle aches, my whole body hurts, nausea, headache, very very tired...I have taken a tums and just slept since 1/5/2021 at 4:00p. I have no appetite.
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| 51 | 2021-01-05 | nausea |
caller couldn't hear properly; got the Covid vaccine last 18Dec2020/her second dose of COVID-19 Vacc...
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caller couldn't hear properly; got the Covid vaccine last 18Dec2020/her second dose of COVID-19 Vaccine was scheduled on 06Jan2021; Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020; Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020; Nausea; Headache; Body aches; fatigue; Cold sweat; This is a spontaneous report from a contactable other health professional. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number reported as either EK5730, ER5730, or EX5730), via an unspecified route of administration on 18Dec2020 16:00 at single dose at left deltoid for COVID-19 immunisation. Medical history and concomitant medications were none. The patient previously had shingles shot in Sep2020, previous shingles shot either three months or six months prior to the one in Sep2020 (2020), both for immunization, and severe myalgia and fever that lasted for two days after the second shingles shot (adverse events followed prior vaccinations). It was reported that did a callback as caller couldn't hear properly. Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020. Want to know if it's safe for her to get the second dose. The patient received Pfizer COVID-19 Vaccine on 18Dec2020 at 16:00. Patient had a couple days worth of symptoms. Now patient had COVID. Patient believed most likely got COVID from her son who was home from college. She was in between dosages of COVID-19 Vaccine. Looked like from research her quarantine would be done on 05Jan2021 and her second dose of COVID-19 Vaccine was scheduled on 06Jan2021. Everything she had read stated if her symptoms were gone to go ahead and get the second COVID-19 Vaccine. Patient wanted to know if Pfizer was doing any studies regarding people who test positive for COVID after receiving the COVID-19 Vaccine. Not sure if Pfizer would be interested in doing antibody studies. Declined obtained COVID-19 Vaccine through work Clarified caller's days worth of symptoms as: Headache the same evening as vaccination. Body Aches: began overnight on 18Dec2020. Fatigue that lasted all week, began overnight on 18Dec2020. Cold sweats: Lasted two days and began overnight on 18Dec2020. Nausea: began on 21Dec2020, not sure if it was related to COVID-19 Vaccine or not. The reporter considered the events weren't serious, but felt like she was having an immunological response. Diagnosed with COVID Seriousness: As of now, not serious. Is having a recurrence of all of those same symptoms as the COVID-19 Vaccine and then some. Lot number provided from patient card. Stated she was unable read it accurately. would take picture in case Pfizer wanted it. Stated lot number was either EK5730, ER5730, or EX5730. A sample of the product was not available to be returned. Vaccination facility type was Hospital, not administered at military site. No additional vaccines administered on same date of Pfizer suspect. No adverse events required a visit to. No prior vaccinations received within 4 weeks. The outcome of the event "Cold sweat" was recovered on 20Dec2020. The outcome of the other events was unknown. The reported considered the events Headache, Body aches, fatigue, Cold sweat, Nausea were related to the suspect drugs. Information on the lot/batch number has been requested.; Sender's Comments: The reported COVID test positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
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| 51 | 2021-01-05 | nausea |
felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling ...
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felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling going down arm/ tingling down to her fingers; A little nausea/nauseated; real tired/ exhausted; muscle aches, just achy feeling; a little dizzy; sinus congestion; feel bad enough; didn't have enough energy; swollen lymph node; its like a little bitty lump in her throat; lymph node's a little bit tender; stated that her head feels congested almost like sinus pressure; stated that her head feels congested almost like sinus pressure; This is a spontaneous report from a contactable nurse reported for self. This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 29Dec2020 15:15 at single dose for covid-19 immunisation. Medical history included migraine, stated that the pressure triggers migraines and she was not going there. Concomitant medications were not provided. Past drug history included stated she took Excedrin migraine because she has history of migraines. She stated it felt like she had the flu, didn't have a temperature and never had a temperature. The first symptom was a dry cough and arm hurt so bad it was tingling going down arm/ tingling down to her fingers and now it felt much better and was able to move. A little nausea/ nauseated, kind of like flu symptoms, was real tired/ exhausted, muscle aches, just achy feeling. She was going to get up and go to work but felt the same symptoms but a little dizzy. Right now, she was feeling a little better but she had this like sinus congestion and the dry cough. She felt bad enough and didn't have enough energy to attend her aunts funeral and was fine yesterday. She also had a little bit of a swollen lymph node. She was not having difficulty breathing or anything like that. She was trying to eat something and its like a little bitty lump in her throat and her lymph node's a little bit tender." She stated she was starting to feel tired. Stated right now head feels congested almost like sinus pressure. Stated she does not have a headache. Stated that she does not have a temperature. Stated that she feels like crap. Stated that she called the nurse at the hospital and she stated that with the vaccination some people are testing positive for Covid. Stated that she was told that if she was having symptoms that she should go get a Covid test. Wanted to know if she should get a Covid test. Wanted to know if she should get the rapid test or 3 day. Outcome of the events felt like she had the flu/ kind of like flu symptoms, dry cough, arm hurt, tingling going down arm/ tingling down to her fingers, nausea, real tired/ exhausted, muscle aches, just achy feeling, a little dizzy, was recovering. Outcome of the event sinus congestion, feel bad enough, didn't have enough energy, swollen lymph node, its like a little bitty lump in my throat, lymph node's a little bit tender, her head feels congested almost like sinus pressure was unknown. Information on the Lot/batch number has been requested.
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| 51 | 2021-01-06 | nausea |
Patient experience severe headache, welts, nausea, extreme fatigue, and reported feeling like walkin...
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Patient experience severe headache, welts, nausea, extreme fatigue, and reported feeling like walking on broken bones. All over body pain.
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| 51 | 2021-01-06 | difficulty swallowing |
Patient had her first dose of Pfizer covid 19 vaccine. She was observed for 30 minutes, 15 minutes ...
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Patient had her first dose of Pfizer covid 19 vaccine. She was observed for 30 minutes, 15 minutes longer than normal as a precaution, due to her allergies. Patient continued to moniter her oxygenation saturation and did not report a drop in oxygen saturation, however, she reported a funny feeling in her throat, difficulty swallowing and shortness of breath. She was escorted to the emergency department via wheelchair for further observation and treatment.
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| 51 | 2021-01-06 | nausea |
Patient started experiencing extreme fatigue and headache on 1/6/2021. She arrived at work on 1/7/20...
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Patient started experiencing extreme fatigue and headache on 1/6/2021. She arrived at work on 1/7/2021 and was experiencing extreme fatigue, severe headache, welts, naussea, and feeling of walking on broken bones. Patient was advised to go home from work.
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| 51 | 2021-01-06 | nausea, retching, vomiting |
Rash, NauseaVomiting, pruritus Narrative: Developed dry heaves, rash and itching 9 min after receiv...
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Rash, NauseaVomiting, pruritus Narrative: Developed dry heaves, rash and itching 9 min after receiving COVID vaccine (1st dose) during observation; Epipen given in vaccination room; transferred to R by ambulance. In ER she was given Diphenhydramine 25 mg PO and Famotidine 20 mg PO. Observed for 1-1/2 hours and discharged.
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| 51 | 2021-01-06 | nausea, vomiting |
UrticariaPruritus & NauseaVomiting Narrative: 1000-Patient stated right hand itching no hives seen; ...
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UrticariaPruritus & NauseaVomiting Narrative: 1000-Patient stated right hand itching no hives seen; VS-126/84;P-76;R-16;SAT-100%; MD at bedside to evaluate. Denies Respiratory difficulties; CP. 1007-Patient states nauseated, RRT at bedside, patient trying to vomit, turned to right side. Dr. from RRT ordered Epi 0.3mg/ml to be given, Epi administered to left thigh, EMS called. 1015- VS; P-69;R-16;BP-110/72, Sat-98, EMS on scene. Patient A & O x4. No difficulty breathing, loaded on EMS stretcher. 1022- VS-127/63; P-73; R-16: Sat-96 and capnography-41. Patient left T205 via EMS at 1022.
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| 51 | 2021-01-06 | indigestion, diarrhea, abdominal discomfort |
had, headache, body aches, chills ,GI upset, heartburn, sweats the next day. then 2 days later had ...
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had, headache, body aches, chills ,GI upset, heartburn, sweats the next day. then 2 days later had loose stools, day 3 swollen lymph nodes in my next. day 4 rash on my back that was red, itched, burned . went away about 12 hours after they came.
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| 51 | 2021-01-07 | nausea |
Headache; nausea; tiredness; site injection swelling; site injection pain; This is a spontaneous rep...
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Headache; nausea; tiredness; site injection swelling; site injection pain; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 28Dec2020 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 28Dec2020, the patient experienced headache, nausea, tiredness, injection site swelling and injection site pain. Treatment was not received for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events headache, nausea, tiredness, injection site swelling, and injection site pain were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 51 | 2021-01-07 | nausea |
Muscle pain; Shortness of breath; Tiredness; Nausea; Sweating; Mild soreness at infection site; Mild...
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Muscle pain; Shortness of breath; Tiredness; Nausea; Sweating; Mild soreness at infection site; Mild soreness at infection site; This is a Spontaneous report from a contactable Other HCP (patient). A 51-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number=EH9899), on 30Dec2020 12:00 PM, Intramuscularly at single dose (first dose), (vaccine location=Left arm) for COVID-19 immunization. Medical history included Covid; Hypertension; Diabetes Type 2. Concomitant medications were not reported. Patient was no Known allergies. Patient experienced Muscle pain, shortness of breath, tiredness, nausea, sweating, mild soreness at infection site on 02Jan2021 09:00 AM. Patient did not receive any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was not recovered. This case was assessed non-serious by reporter. And the events did not result in Death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
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| 51 | 2021-01-07 | diarrhea |
Myalgia & Diarrhea Narrative: Employee called OHC to report side effects that occurred the night of...
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Myalgia & Diarrhea Narrative: Employee called OHC to report side effects that occurred the night of vaccination and now getting better.
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| 51 | 2021-01-08 | diarrhea | Diarrhea |
| 51 | 2021-01-08 | vomiting | Patient developed tachycardia, vomited and trouble breathing |
| 51 | 2021-01-09 | nausea |
1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 13...
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1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 1330 still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 1415 reported to the vaccination clinic and told them of symptoms, SOB with movement, and general pressure in the chest. 2 Tylenol taken. I was required to check into the ER for Observation. oxygen saturation checked for 2 hours. no change in symptoms, no worsening. I then left work in the ER and went home. At approx. 1800 ate dinner, no real taste, but needed to eat. At 1830 showered, 2000 to bed, just feeling malaise. continued pressure in the chest and general soreness. 2 Tylenol Through the night I slept very poorly, tossed and turned, woke frequently. Body and joints with extreme pain everywhere it touched the mattress. I have a screw in my left foot, it felt like it was on fire at some point during the night. My left leg ached up into my hip. On the morning of January 8, woke approx 0800 with a temperature of 99.9, pain in all my joints, back and up into neck, headache, and nausea. Took 2 Tylenol, 3 ibuprofen, and 4 mg Zofran. 1200 symptoms began to lessen and felt like I had the flu, still sore, but less severe. 1300 - 2 Tylenol Slept better, just sore January 8 night. January 9 - 2 Tylenol in the morning, sore everywhere, right arm site sore, headache, eye pain, intermittent nausea. 2 more tylenol around 1800 January 10, 2 tylenol 0900, remain sore but lessening, headache and eye pain continues, intermittent nausea
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| 51 | 2021-01-09 | nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA I woke on the 18th with extreme fatigue and nausea, fell asleep...
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Pfizer-BioNTech COVID-19 Vaccine EUA I woke on the 18th with extreme fatigue and nausea, fell asleep twice during the day while sitting on the couch. Lessened and became just tired by Sunday Dec 19.
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| 51 | 2021-01-09 | nausea |
Tachycardia almost immediately after injection 100-110s. Slight tightness of chest, but I was tryin...
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Tachycardia almost immediately after injection 100-110s. Slight tightness of chest, but I was trying not to panic. Tachycardia increased to 130s for 2 minutes then came down to 100s, BP 140/86, a little nausea and slight headache. Better at 4:45 thought I was good to leave. Then BP spiked to 180/110s, HR 136, transported to ER for monitoring. Tachycardia and HTN would continue to cycling elevate over next 2hours before being discharged with HR of 100s and BP 150/86
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| 51 | 2021-01-10 | nausea | Dizzy, Headache, unsteady on feet, chest feels heavy, nauseated |
| 51 | 2021-01-10 | nausea |
Felt immediately dizzy, lasted several hours, somewhat nauseous and slight headache now 9 hours late...
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Felt immediately dizzy, lasted several hours, somewhat nauseous and slight headache now 9 hours later and still currently active with these symptoms.
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| 51 | 2021-01-10 | decreased appetite |
I am a health care professional and received my first vaccine 12/17/20. I had the my first reaction...
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I am a health care professional and received my first vaccine 12/17/20. I had the my first reaction on 12/19/20. Horrible fatigue, body aches. My second dose was given on 1/7/21. After 6 hours, I felt myalgias, arthralgias, skin sensitivity to anything that touched me. Severe fatigue and headache. Took Tylenol with no relief. The worst day hit at 1/8/21 at 3:00 a.m. I could not move without extreme pain. Sweating and chills. No appetite. Had to be assisted to toilet. Tried to go into hospital to do vaccine clinic today, 1/11/21 and had to return home as I was extremely fatigued and excessive sweating.
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| 51 | 2021-01-10 | decreased appetite |
Started having chills at 11pm, took tylenol 650mg. However, the symptoms not relieved, could not sle...
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Started having chills at 11pm, took tylenol 650mg. However, the symptoms not relieved, could not sleep the whole night. fever went up to 101F. Also feeling extreme fatigue, not able to get up from the bed, took another dose 1000mg tylenol, completely lost appetite, body ache. Low grade ever lasted up to 1/8/21. Even now still feeling fatigue and frequent headache. The injection site felt fine two days following injection. But started feeling inlamed and painful on 1/8/21. On 1/9/21, the pain of the site expanded towards the armpit and left upper shoulder and back.
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| 51 | 2021-01-10 | nausea |
Vaccine recipient reported that in the afternoon after receiving their vaccine, they experience seve...
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Vaccine recipient reported that in the afternoon after receiving their vaccine, they experience severe headache and nausea. They also developed chills, body ache, and arm pain at night. On a follow up call on 1/11/2021, they reported that their symptoms resolved on 1/8/2021.
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| 51 | 2021-01-11 | diarrhea, nausea |
Fatigue; Dizziness, Light-headed; nausea; diarrhea; swelling of face; muscle pain; chills; joint pai...
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Fatigue; Dizziness, Light-headed; nausea; diarrhea; swelling of face; muscle pain; chills; joint pain; Overall feeling of unwell; This is a spontaneous report from a non-contactable other HCP (patient). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EK5730, via an unspecified route of administration on 31Dec2020 at single dose on arm right for COVID-19 immunisation. Medical history included fibromyalgia and known allergies: Rose hip tea and Diclofenac. No COVID prior vaccination. No pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included zolpidem tartrate (AMBIEN) and duloxetine hydrochloride (CYMBALTA). The patient experienced fatigue, dizziness, light-headed, nausea, diarrhea, swelling of face, muscle pain, chills, joint pain, overall feeling of unwell; all on 01Jan2021. No treatment received for the events. Outcome of events was not recovered. Since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 51 | 2021-01-11 | nausea | Nausea, body aches, dizziness, mouth/tooth pain |
| 51 | 2021-01-11 | nausea |
achiness; Headache; Dizziness; Disorientation; Nausea; This is a spontaneous report from a contactab...
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achiness; Headache; Dizziness; Disorientation; Nausea; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, expiration date: Mar2021), via an unspecified route of administration at the left arm on 05Jan2021 12:10 at a single dose for COVID-19 immunization in the hospital. The patient has not had any vaccines in four weeks. The patient has no medical history. There were no concomitant medications. The patient received the COVID vaccine on 05Jan2021 and confirmed that it was the first dose she received of the COVID vaccine. She clarified that she started to have dizziness, disorientation, nausea, achiness and headache. The dizziness, disorientation and nausea started about 8 hours after she received the vaccine, 05Jan2021 20:10. She stated that she was just trying to push through with the side effects. She woke up in the morning, 06Jan2021, feeling both achy and with a headache. She stated that she had the achiness that was regular and knew would normally come along with it. However, she also had a headache. The outcome of the events was not recovered.
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| 51 | 2021-01-12 | diarrhea | 1/8/21 fatigue, chills, cough, congestion, diarrhea. 1/8/21 Dx'd with Acute viral syndrome |
| 51 | 2021-01-12 | nausea |
Chills; Joints were sore; Left upper arm is sore; Nausea; Light-headed; Tired; allergies; allergies;...
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Chills; Joints were sore; Left upper arm is sore; Nausea; Light-headed; Tired; allergies; allergies; Body was not feeling well, she felt like she was getting the flu; Body was not feeling well, she felt like she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: E10142), via an unspecified route of administration on left upper arm at 10:40 AM on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hip replacement from Aug2020 (Right hip replaced in Aug2020, she was a runner and this is due to wear and tear), allergies, family history included diabetes and high blood pressure. Concomitant medication included cetirizine hydrochloride (ZYRTEC). Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. The patient previously received flu vaccine for immunization. The patient was having symptoms, nothing life threatening but she wanted to report them. Weight: 150lb-152lb. She was in healthcare but not a healthcare provider, she work in a outpatient clinic. Her first shot was on 05Jan2021. That day she experienced nausea and was light headed in the evening on 05Jan2021. She thought it was her allergies. She was really tired and went to bed really early that night. She got chills last night on 06Jan2021 and her body was not feeling well, she felt like she was getting the flu. Her joints were sore and her head started to hurt. The nausea, light headedness and tired feeling got worse last and she went to bed even earlier that night. She took her temperature this morning, she didn't take it last night as she knew she would get some symptoms from the shot, and she had no fever. Sometimes got light symptoms from the flu vaccine that she got every year, she had no product name, NDC, Lot, or Expiry for that product. When she woke up her head was still killing her but felt sickly. She went to work, she just thought she would power through it but she felt like she could go home and go right to sleep. The day of the shot she took a One a Day Women for 50 and over and a Zyrtec. Yesterday morning she took the Zyrtec but not the vitamin and she didn't take either this morning due to her stomach. She was told she should take Tylenol so maybe she would take that today. It was also noted that her left upper arm was sore where she got the shot on 05Jan2021, it had gotten better today. The outcome of events feeling unwell and flu-like illness was unknown. The outcome of event pain in arm was recovering, the outcome of rest events was not recovered.
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| 51 | 2021-01-12 | diarrhea, vomiting, nausea |
Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to ...
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Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to left neck and under arm, chest pressure, vomiting, and loose stools
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| 51 | 2021-01-12 | nausea | Left arm pain, armpit pain, body aches, shaking chills, nausea, extreme tiredness |
| 51 | 2021-01-12 | nausea |
Severe pain at site starting by 1800 01/11/2021. 01/12/2021 Severe pain at site kept me awake most t...
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Severe pain at site starting by 1800 01/11/2021. 01/12/2021 Severe pain at site kept me awake most the night, headache, nausea, joint pain starting at 0615 01/12/2021 which continued to get worse through out the day. Left work early 01/12/2021. Woke 01/13/2021 with slight headache still.
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| 51 | 2021-01-12 | abdominal pain upper, nausea |
gut wrenching nausea; stomach ache; flushed; dizzy; Headache; This is a spontaneous report from a co...
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gut wrenching nausea; stomach ache; flushed; dizzy; Headache; This is a spontaneous report from a contactable other HCP(patient). A 51 years old female patient received first dose BNT162B2(lot number EL0140), via an unspecified route of administration on 29Dec2020 08:00 at the 51 years old at Arm Left at single dose for COVID-19 immunization. The patient medical history was none. The concomitant medications were none. The patient had her first dose on 29Dec2020, she had no fever or chills and she got it at 8AM, and she woke up on 30Dec2020, and for the last 9 days when she wakes up, she was gut wrenchingly nauseated. It lasted like up to sometimes until noon, she still had a little nausea now, and it is almost noon there, and this comes along with being so nauseated. She was having a pretty moderate stomach ache on 30Dec2020, especially after eating, then she was really felt flushed and dizzy on 30Dec2020, but she thought because the nausea was so bad. She had a headache on 30Dec2020 and lasted for 5 days. She was not sick prior to the COVID vaccine. The outcome of the event Headache was recovered on 04Jan2021, the other events was not recovered.
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| 51 | 2021-01-13 | nausea |
Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30a...
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Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30am, told my husband that I did not feel right and it felt like something was wrong with me. I asked him to send a message to work that I was not feeling well and would not be in. I was not able to see my phone clearly as I had double vision. I went back to sleep to try to get relief, woke up and called out to husband for help and he said I was just making groaning noises but I know in my head I was saying please help me as I could not move my right side and I was not sleeping or having a dream. At approximately 9:30am my husband kept telling me someone was trying to text me and needed a response. I tried to get up and still could not move my right side. He helped me sit up and I could not use my right arm and hand. He helped me get some clothes on and took me to the ED. When we arrived I still could not use my right hand and my arm still felt weak. The weakness resolved within a couple of hours and I got the strength back in my hand. I did have some concern that my TIA type symptoms could possibly be related to vaccine but it was just a thought until I received my second dose. 3 hours post vaccine my face became numb and tingly. It remained that way until I went to sleep. This is why I am reporting this incident.
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| 51 | 2021-01-13 | nausea |
Hot flash, dizziness, nausea, cold chills, headache. Right side of body numbness and tingling, no se...
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Hot flash, dizziness, nausea, cold chills, headache. Right side of body numbness and tingling, no sensation of hot/cold.
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| 51 | 2021-01-13 | nausea, abdominal discomfort |
Initial injection area hurt for 2 days. Began feeling overall sluggish, upset stomach, nausea and f...
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Initial injection area hurt for 2 days. Began feeling overall sluggish, upset stomach, nausea and flu like symptoms. Next day the symptoms progressively got worse to include chills, body aches and joint pain and headaches, sluggish and no energy. Had to leave work early due to feeling tired, no energy and went home slept rest of day throughout night, unable to eat. Symptoms stayed the same throughout a Friday Jan 8th still with chills, aches, joint pain and headaches, nausea started to subside finally ate some soup and drank liquids , again was sluggish no energy still and went to bed early. Saturday January 9ththe headaches subsided and I started to feel better... Saturday January 9ththe headaches subsided and I started to feel better, but still did not feel like myself, all over less aches and pains but still not feeling well, still tired and Sunday the same but was able to have an appetite. Monday went into work still not 100% but was able to function. Started feeling like myself by wednesday 1/13.
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| 51 | 2021-01-13 | diarrhea | Reported headache, chills, greater than 6 loose stools overnight. Symptoms have resolved. |
| 51 | 2021-01-13 | diarrhea, vomiting, nausea | Same day as vaccination ee had comiting, diarrhea, nausea, severe headache lasted for 10 days. |
| 51 | 2021-01-13 | nausea |
Severe headache middle of night first night accompanied by nausea Moderate headache next 48 hrs Fat...
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Severe headache middle of night first night accompanied by nausea Moderate headache next 48 hrs Fatigue Aches first 24 hrs more unusual reaction => starting on day 2, hives/rash over most of the body for <24hrs
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| 51 | 2021-01-13 | nausea | Sudden onset of splitting headache with nausea, chills |
| 51 | 2021-01-14 | diarrhea, nausea |
24 hours waves of nausea and sweats started, then a short time later a bad headache and about 40 min...
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24 hours waves of nausea and sweats started, then a short time later a bad headache and about 40 minutes later diarrhea and chills. Also very fatigued and just feeling off.
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| 51 | 2021-01-14 | nausea | Fever, shivers, nausea fatigue. Treatment: Tylenol outcome: complete resolution of symptoms. |
| 51 | 2021-01-14 | nausea |
R arm pain--at site of injection; significant nausea; headache; body aches; chills; fatigue; This is...
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R arm pain--at site of injection; significant nausea; headache; body aches; chills; fatigue; This is a spontaneous report from a contactable Physician (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL6142), via an unspecified route of administration on 07Jan2021 14:45 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Medical history included hypothyroidism, hx of Hodgkins from 1994, breast cancer from 2005. Concomitant drug included levothyroxine sodium (SYNTHROID). The known allergies included Bactrim, bacitracin, non-ionic contrast. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Right arm pain - at site of injection, significant nausea, headache, body aches and chills. fatigue on 07Jan2021 20:00 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
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| 51 | 2021-01-14 | nausea |
Severe Headache; body ache/pain; malaise; nausea; This is a spontaneous report from a contactable co...
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Severe Headache; body ache/pain; malaise; nausea; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 16Dec2020 at single dose for Covid-19 immunization. The patient is not pregnant. Medical history was none. The patient had no known allergies. The patient's concomitant medications were not reported. It was unknown if other vaccine was administered in four weeks. On 07Jan2021, the patient experienced severe headache, body ache, malaise, pain and nausea fit for 30 hours. Prior vaccination the patient had no COVID. It was unknown if the patient was COVID tested post vaccination. No treatment received for the events. The patient recovered from the events on unspecified date in Jan2021. Information on the batch number has been requested.
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| 51 | 2021-01-17 | nausea |
BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe ...
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BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe nausea (but could be from headache).; Possible migraine; Mild photophobia; Mild photophobia; This is a spontaneous report from a contactable Physician who reported for herself. A 51-year-old female patient received her second single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EL3249) at left arm at 17:30 06Jan2021 for Covid-19 immunization in a hospital. She had her first injection at 07:15 PM 18Dec2020 and experienced mild photophobia within 5-10 min. The patient had a medical histroy of allergic rhinitis and was allergic to cashews. Concomitant medications included fexofenadine, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12). The patient did not receive any other vaccines within 4 weeks prior to her first COVID vaccine. Within 5-10 minutes of 2nd injection, the patient had mild photophobia (also after 1st injection but patient did not recognize the symptom at that time). About 20 hours after 2nd injection, the patient developed severe sharp headache behind left eye, severe nausea (but could be from headache/ possible migraine). The patient stated that she had no prior history of migraines or frequent headaches. Three days after 2nd dose, the patient's lingering intermittent mild left-sided headache persisted. The patient self-administered OTC oral analgesics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events headache, nausea, migraine, photophobia at the time of last observation was resolving. The patient considered that the events were non-serious.
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| 51 | 2021-01-17 | diarrhea | Fatigue , Chills, congestion, runny nose, diarrhea x3 days -DX ACUTE VIRAL SYNDROME |
| 51 | 2021-01-17 | nausea |
Nausea, palpitations, Headache, Chills, severe achiness and fatigue, fever, pain at the injection s...
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Nausea, palpitations, Headache, Chills, severe achiness and fatigue, fever, pain at the injection site and whole injection site arm soreness.
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| 51 | 2021-01-17 | nausea | Nausea;headache;chills;muscle pain;tiredness Feel unwell. |
| 51 | 2021-01-18 | nausea |
Fever lasting 2 days, injection site soreness, nausea, joint pain for 2 days, hair loss for 2 weeks,...
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Fever lasting 2 days, injection site soreness, nausea, joint pain for 2 days, hair loss for 2 weeks, extreme fatigue for 2 weeks
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| 51 | 2021-01-18 | indigestion |
Her stomach is still weirded out/sour stomach; feeling sick; arm pain; She was sick to her stomach; ...
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Her stomach is still weirded out/sour stomach; feeling sick; arm pain; She was sick to her stomach; kidneys were hurting; body aches; tested positive; tested positive; The arm wasn't swollen it was just burning.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. At first, she thought she was having a reaction, but then she started feeling sick so she got tested. She was positive so she wasn't having a reaction. She was scared from the pain of COVID. She experienced sickness. Her stomach was still weirded out. She did experience arm pain from the vaccine. Her doctor told her it was fine that it needed to air out. She left the bandage on too long. She didn't have a prescribing doctor. She received the vaccine on the 29Dec2020. She tested positive 02Jan2020. The arm wasn't swollen it was just burning. She was sick to her stomach when she got the stomach. The sick to the stomach lasted maybe two days, but then she got COVID. The burning was around the arm. It wasn't that bad. It lasted for a day. It started the day she got the shot (on the 29Dec2020). On 07Jan2021, she went to the hospital because her kidneys were hurting. The doctor said her kidneys were good. They did labs which were good. She was still going through body aches. She was told she was currently in the worst part of the virus. She still had a sour stomach going on from the virus as well. The outcome of the body aches and sour stomach was not recovered, for other events was unknown.
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| 51 | 2021-01-18 | decreased appetite, diarrhea | Pain at injection site, diarrhea, loss of appetite, thirst, joint pains, fatigue, chills |
| 51 | 2021-01-18 | nausea |
Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sne...
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Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sneezing; Body aches; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 14:50 at single dose at right arm for covid-19 immunization. No additional vaccines administered on the same date. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included ongoing migraine. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH) for migraine, patient had been alternating this with paracetamol (TYLENOL) while she has been recovering. She clarified the symptoms she experienced as the same day she got the vaccine that evening she had a headache on 29Dec2020. It eventually became a migraine and she left work early. On 30Dec2020 she had body aches, little nausea, and chills. On 31Dec2020, she had more chills, a runny nose, she felt like she was coming down with a cold. She was sneezing, had more chills, more body aches. On 01Jan2021 she felt like she noticed she had phlegm in her throat, but she did not have any pain. The phlegm was causing her to cough more. She had a runny nose the next morning as well. She did the rapid test for COVID on 02Jan2021 evening, and it was positive. She had a headache almost every day. The body aches had pretty much worn off. Runny nose and sneezing resolved in Jan2021. Phlegm in throat confirmed with no pain. This also resolved, as well as coughing. Outcome of event tested positive for COVID was unknown, outcome of event headache was not recovered. outcome of event nausea was recovered on 07Jan2021, event chills was recovered on 08Jan2021, outcome of other events was recovered on unspecified date in Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Information of lot/batch number has been requested.
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| 51 | 2021-01-19 | abdominal discomfort, diarrhea, nausea |
Back pain,fever,chills,muscle aches, headache, diarrhea, upset stomach , nausea, severe head fog , D...
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Back pain,fever,chills,muscle aches, headache, diarrhea, upset stomach , nausea, severe head fog , Disiness, feels like electrical currents in head and ears. These symptoms have been all 7 days.
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| 51 | 2021-01-19 | abdominal pain, nausea | Nausea: I was seen at for Nausea. and abdominal pain. |
| 51 | 2021-01-19 | abdominal pain upper, diarrhea | Stomach cramps, diarrhea, slight chill |
| 51 | 2021-01-20 | nausea, vomiting |
12 days after 2nd vaccine-started with fever/chills, cervical lymphadenopathy and redness/vesicular ...
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12 days after 2nd vaccine-started with fever/chills, cervical lymphadenopathy and redness/vesicular type eruption on nose. Fever/chills persisted through night, followed by 16hr N/V and worsening of eruption- vesicular/pustular on nose, then with subsequent right facial swelling.
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| 51 | 2021-01-20 | nausea |
Fatigue; arm pain at shot site; muscle aches; nausea; fever; basic flu symptoms; This is a spontaneo...
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Fatigue; arm pain at shot site; muscle aches; nausea; fever; basic flu symptoms; This is a spontaneous report from a non-contactable other HCP (Patient). A 51-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at left arm on 08Jan2021 09:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included asthma, covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 18Dec2020 09:30 at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Jan2021 at time of 06:30 PM, the patient experienced fatigue, arm pain at shot site, muscle aches, nausea, fever, basic flu symptoms. No treatment received for the events. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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| 51 | 2021-01-20 | diarrhea, vomiting | Fever, chills, severe headache, vomiting, diarrhea for 2 days |
| 51 | 2021-01-20 | vomiting | Vomiting, fever,severe bone pain |
| 51 | 2021-01-20 | vomiting, diarrhea | body aches vomiting diarrhea temp 101 chills flat, red, splotchy rash |
| 51 | 2021-01-20 | nausea |
feeling malaise; general soreness/Body and joints with extreme pain everywhere it touched the mattre...
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feeling malaise; general soreness/Body and joints with extreme pain everywhere it touched the mattress; no real taste; chest pressure/tightness/ general pressure in the chest; SOB/ SOB with movement; Body and joints with extreme pain everywhere it touched the mattress; a screw in left foot, it felt like it was on fire at some point during the night; My left leg ached up into my hip; fever 99.9; HA; eye pain; intermittent nausea; This is a spontaneous report from a contactable nurse (patient). This 51-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142) on 07Jan2021 at 11:15, in right arm, for COVID-19 immunisation. Medical history included asthma, allergies to latex, banana, kiwi and acetylsalicylic acid (ASPIRIN). The patient received the first dose of BNT162B2 vaccine on 17Dec2020 at 19:45, lot number EJ1685, in right arm. The patient had no COVID prior vaccination. No other vaccine was given in 4 weeks. COVID was not tested post vaccination. Concomitant medications included thyroid (ARMOUR THYROID) and escitalopram. On 07Jan2021 at 12:30 the patient began experiencing SOB; assumed it was asthma, 2 puffs of albuterol were taken. At 13:30 she had still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 14:15 reported to the vaccination clinic and told them of symptoms, SOB with movement and general pressure in the chest. 2 paracetamol (TYLENOL) were taken. She had to check into the ER for observation. Oxygen saturation was checked for 2 hours. No change in symptoms, no worsening. She then left work in the ER and went home. At approximately 18:00 she ate dinner, no real taste, but needed to eat. At 18:30 she showered, at 20:00 she went to bed just feeling malaise, continued pressure in the chest and general soreness. 2 Tylenol. Body and joints with extreme pain everywhere it touched the mattress. She had a screw in her left foot, it felt like it was on fire at some point during the night. Her left leg ached up into her hip, she had fever 99.9, continued to 10Jan2021 with malaise, HA, eye pain, intermittent nausea. The events had not yet resolved at the time of report.
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| 51 | 2021-01-21 | nausea |
Chills, nausea, I felt feverish but did not take my temperature, I had sweats, headache, warm and at...
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Chills, nausea, I felt feverish but did not take my temperature, I had sweats, headache, warm and at the injection site it swollen and red happened in the middle of the night. For the next 2 days I had extreme fatigue and after that I was fine (by Sunday). I did not have any energy but no chills or nothing. I took Tylenol and it helped me. I was able to return to work on Monday and as the day passed I started feeling like myself. I also developed a lump on my neck on 01/18/2021 on the left side (on my collarbone) and my PCP prescribed Doxycycline 2 tablets a day. I also developed a lump on my right side when I took the first dose and took a ZPack and that lump is still here on my neck.
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| 51 | 2021-01-21 | abdominal discomfort |
Developed a fever and bad body aches around 9:00 pm the evening of the shot. My stomach was very up...
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Developed a fever and bad body aches around 9:00 pm the evening of the shot. My stomach was very upset and couldn?t eat. Had bad headache.
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| 51 | 2021-01-21 | nausea |
Feeling of warmth on head and face at 9:00pm on 1/19/21 Woke with fever (99.6F), shaking chills, he...
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Feeling of warmth on head and face at 9:00pm on 1/19/21 Woke with fever (99.6F), shaking chills, headache at 4:00am on 1/20/21 Fever (100.6) joint pain, muscle pain at 9:00am Fever 101.0 at 1:00pm with intense headache, muscle and joint pain accompanied by dizziness, nauseous, fatigue, malaise. Fever 101.0 at4:00pm. Accompanied by symptoms listed above.Took 1,000mg Tylenol. Fever 101.0 at10pm. Accompanied by symptoms listed above. Took 1,000mg Tylenol. Insomnia. 1/21/21: Fever 99.0 degrees 4am. 1,000mg Tylenol. Intense headache and neck ache, muscle and joint pain accompanied by dizziness, nauseous, fatigue, malaise 1/21/21: Fever resolved at 6pm. Intense headache and neck ache, muscle and joint pain accompanied by dizziness, nauseous, fatigue, malaise 1/22/21: Body aches, headache, fatigue, malaise, fatigue, dizziness, nausea
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| 51 | 2021-01-21 | nausea |
HIGH FEVER (102), BODY ACHES, NAUSEA, CHILLS, MIGRAINE, ARM PAIN. THE SYMPTOMS CAME ON GRADUALLY OVE...
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HIGH FEVER (102), BODY ACHES, NAUSEA, CHILLS, MIGRAINE, ARM PAIN. THE SYMPTOMS CAME ON GRADUALLY OVER THE FIRST 24 HRS AND THEN STARTED TO DISSIPATE AFTER ABOUT 36 HRS AND WERE COMPLETELY GONE IN 48 HRS. TOOK ADVIL. SLEEP.
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| 51 | 2021-01-22 | decreased appetite, nausea |
20 Jan 2021 face and arms reddening and burning about half hour after injection. 21 Jan 2021 fatigu...
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20 Jan 2021 face and arms reddening and burning about half hour after injection. 21 Jan 2021 fatigue, body aches, dizziness throughout day, went to bed very early no appetite, nauseous 22 Jan 2021 fatigue, body aches, dizziness. Temp 99.3 higher than normal. No appetite 23 Jan 2021 condition improved. No symptoms.
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| 51 | 2021-01-22 | abdominal pain |
Fever, body ache, joint pain, fatigue first two days, Sore Throat, headache abdominal pain, bowel ch...
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Fever, body ache, joint pain, fatigue first two days, Sore Throat, headache abdominal pain, bowel changes and fatigue 3rd and 4th day.
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| 51 | 2021-01-22 | vomiting, decreased appetite |
The next day I had a high fever of 101+ and couldnt get out of bed, vomited up some water I drank, w...
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The next day I had a high fever of 101+ and couldnt get out of bed, vomited up some water I drank, was achey all over, no appetite and felt awful for about 6 hours.
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| 51 | 2021-01-23 | decreased appetite |
By 10pm on 1/23/21, I was experiencing chills, fatigue, and swollen lymph node in my right armpit a...
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By 10pm on 1/23/21, I was experiencing chills, fatigue, and swollen lymph node in my right armpit as well as soreness at the injection site (which started hours earlier). On 1/24/20, chills and extreme fatigue continued along with dull headache, lack of appetite, and general feeling of unwellness. Temperature at 3:30pm was 101.2F.
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| 51 | 2021-01-23 | nausea | Joint pain, chills, nausea and fever |
| 51 | 2021-01-24 | nausea |
I felt light headed on the way home from the vaccine 1/23/21. At around midnight, I woke up with chi...
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I felt light headed on the way home from the vaccine 1/23/21. At around midnight, I woke up with chills. At 2am, I woke with more chills and a splitting headache. I took Tylenol which decreased the symptoms. All day on Sunday, I had a horrible headache, a fever of 101F, body aches (muscles and joints), cramping, nausea, terrible fatigue. I took Tylenol every 4 hours which did help some. Today, I feel fatigued, fever is gone, I feel nauseated.
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| 51 | 2021-01-24 | nausea, vomiting | N/V, Cough |
| 51 | 2021-01-24 | nausea |
Within 5 minutes, throat closing and generalized itchiness, tongue swelling, joint ache, skin on fir...
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Within 5 minutes, throat closing and generalized itchiness, tongue swelling, joint ache, skin on fire, short of breath. 2 doses of PO Benadryl at clinic, transferred to ED where she received epinephrine and 4 days of prednisone and allergy consult. Nausea began evening of 1/21/21 with headache. Fever 100.6 began 1/22/21. Headache and nausea still remain, not fully recovered.
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| 51 | 2021-01-24 | nausea | pain at site, joint pain, headache, fever and nausea |
| 51 | 2021-01-25 | nausea | nausea, tiredness and cold |
| 51 | 2021-01-26 | nausea | Dizziness, nausea, fever, chills, HA, muscle aches, fatigue |
| 51 | 2021-01-26 | vomiting |
Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, d...
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Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, difficulty breathing, swollen face, rash on the neck , torso and arms, itchiness of the eyes, chills . Took some benadryl, cream and pills. Next day malaise, swollen hands, body aches.
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| 51 | 2021-01-26 | nausea | Nausea, fever, bodyaches, headache, fatigue, rash |
| 51 | 2021-01-26 | indigestion, vomiting, nausea |
nausea, vomiting, burning in the stomach, itching in the throat., I couldn't talk. high blood pressu...
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nausea, vomiting, burning in the stomach, itching in the throat., I couldn't talk. high blood pressure. I was administered solumedrol intravenous, Benadryl intravenous, Pepcid intravenous and Zofran sublingual and NSS 0.9 to 10 ml per hour.
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| 51 | 2021-01-27 | nausea, vomiting |
Within 20 minutes, wave of nausea. Vomited on way home, very intense wave of fatigue, could barely s...
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Within 20 minutes, wave of nausea. Vomited on way home, very intense wave of fatigue, could barely stand/walk - unbalanced, dizziness, spinning - like terrible, sudden vertigo. Had to sleep off about 4-5 hours and feel better now.
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| 51 | 2021-01-27 | nausea |
approximately 15 minutes following administration, pt felt nauseous, diaphoretic and dizzy. pt did n...
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approximately 15 minutes following administration, pt felt nauseous, diaphoretic and dizzy. pt did not feel sob or chest tightness. Pt escorted to room to lie down. VS obtained
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| 51 | 2021-01-27 | diarrhea, abdominal discomfort |
slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuf...
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slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff; slight tingling and numbness of her face and cheeks/little tingling numbness in her face; slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff/she has not had symptoms for years, potentially initiated by being vaccinated; Headache; Diarrhea; Stomach upset; warm flushed feeling; heavy metallic taste to her mouth; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 07Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing multiple sclerosis (MS) from 2012 (she has not had symptoms for years), tingly stuff/tingling and numbness (MS symptoms). There were no concomitant medications. The patient experienced metallic taste in her mouth, a slight tingling and numbness of her face and cheeks. The patient reported that she also has a history of MS that has been controlled and she has been without symptoms for years. She stated the tingling could be a symptom of MS, potentially initiated by being vaccinated. She stated that the tingly stuff concerned her, she got a little panicky because that can be a symptom of MS and she did not have symptoms for years. The patient clarified that on 07Jan2021, she took the vaccine. On 07Jan2021, she experienced heavy metallic taste to her mouth two hours after the injection, headache, diarrhea, stomach upset, and warm flushed feeling. On 08Jan2021, she experienced little tingling numbness in her face. She stated that she has MS prior to the vaccine and reported that numbness and tingling can be MS symptoms. She has not had symptoms for years. The patient did not receive treatment for the events. The outcome of "heavy metallic taste to her mouth" was recovering (reported as "improved but persisting"); paraesthesia and hypoeasthesia were recovering; headache, diarrhea, stomach upset, and warm flushed feeling were resolved on 09Jan2021.
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| 51 | 2021-01-28 | nausea |
cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble...
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cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble finding words; extreme fatigue; nausea; achiness at joints; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0140, expiry date unknown), via an unspecified route of administration (vaccine location: left arm), on 23Dec2020 17:00, at single dose, for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes - all on 24Dec2020. These symptoms never left up until day 21 when the patient received her next shot. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination, and had not been Covid-tested post vaccination. It was unknown if treatment was received for the adverse events. The patient was recovering from the events.
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| 51 | 2021-01-28 | diarrhea |
headache; Diarrhea; dizziness/severe dizziness; weakness/very weak; muscles and joints are aching an...
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headache; Diarrhea; dizziness/severe dizziness; weakness/very weak; muscles and joints are aching and painful; muscles and joints are aching and painful; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no: EL1284, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose on left arm for Covid-19 immunization. Medical history included pre-diabetes 3-4 years ago. The patient's concomitant medications were not reported. Certified Nursing Assistant said that she has been experience some side effects from the Pfizer-BioNTech Covid-19 Vaccine which she took two days ago, 13Jan2021. She said she was having side effects include headache on an unspecified date. Furthermore, she experienced diarrhea, dizziness/severe dizziness, weakness/very weak and muscles and joints are aching and painful on 14Jan2021. The outcome of all events was not recovered except for headache that was unknown. She wanted to know what she should take and what she should do about these symptoms.
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| 51 | 2021-01-28 | nausea |
vertigo; dizzy; nauseated; This is a spontaneous report from a contactable consumer, the patient. A ...
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vertigo; dizzy; nauseated; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3249), via an unspecified route of administration in the left arm on 16Jan2021 at 15:30 PM (at the age of 51-year-old) as a single dose for COVID-19 vaccination. Medical history reported as none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included bupropion hydrochloride (WELLBUTRIN), sertraline hcl (ZOLOFT), zolpidem tartrate (AMBIEN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Jan2021 at 07:00 AM, the day following her vaccine, the patient had severe vertigo. It lasted most of the day. She was extremely dizzy and felt nauseated. She did not throw up, however. The patient did not receive any treatment for the events. The clinical outcome of the events vertigo, dizzy, and nauseated was recovered on unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-01-29 | abdominal pain, abdominal pain upper | Intense continuous RUQ abdominal pain |
| 51 | 2021-01-31 | nausea, diarrhea | Diarrhea & Nausea |
| 51 | 2021-01-31 | diarrhea |
diarrhea; tired; headache; chills; This is a spontaneous report from a contactable other HCP (patien...
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diarrhea; tired; headache; chills; This is a spontaneous report from a contactable other HCP (patient). A 51-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration in left arm on 16Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing Diabetes, Type 2 (Caller was diagnosed with this about 10 to 15 years ago), patient states that she has noticed that her blood sugars have gone up a bit. Patient states that she thinks that her sugars are up just because of stress on the body, because she had cancer and when she was going through her cancer, her sugars were all out of whack. Patient states that any time her body is stressed her sugars will go up. There were no concomitant medications. Patient states that she got the COVID Vaccine on Saturday 16Jan2021, and since then on 17Jan2021, she has been really tired, has a headache, and has chills; but caller states that all that is normal side effects that she read about. Caller states that the side effect she is concerned about is diarrhea, and she is wondering if that is a known side effect of the product. Caller received the vaccine on Saturday 16Jan2021, and her symptoms all started the next day on 17Jan2021. Caller confirms all symptoms are still ongoing but they have all improved. Caller confirms that she received no other vaccines on the same day as the COVID vaccine. The outcome of the events was recovering.
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| 51 | 2021-01-31 | nausea |
malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; ...
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malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; muscle pain; nausea; dizziness; swollen entire left arm injection arm; joint pain; kidney pain; unable to think clearly; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 13Jan2021 12:00 PM at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020, 05:00 PM at a single dose on left arm for COVID-19 immunization and experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes. The patient experienced malaise, feeling of severe unwell, migraine and neck pain, heart racing, blurry vision, muscle spasms, muscle pain, nausea, dizziness swollen entire left arm injection arm, joint pain, kidney pain, unable to think clearly on 14Jan2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain and nausea. The outcome of the events was recovering. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
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| 51 | 2021-02-01 | indigestion |
STOMACH STARTED BURNING; This is a spontaneous report from a contactable consumer (patient). A 51-ye...
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STOMACH STARTED BURNING; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at 14:00 at single dose in left arm for covid-19 immunisation at 51-year-old. Lot number was EL1283. Medical history and concomitant medications were unknown. The patient was not pregnant at the time of vaccination. Past drug history included allergy to Benadril and Vicodin. On 21Jan2021 at 14:00, as soon as the patient got the shot stomach started burning and was still burning. The patient was not treated for the event. The patient did not recover from the event.
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| 51 | 2021-02-03 | abdominal discomfort |
After first vaccine about 25 mins after the shot, the tip of my tongue and lips went numb. I had gen...
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After first vaccine about 25 mins after the shot, the tip of my tongue and lips went numb. I had general fatigue the remainder of the day. The day following I was aching, bad headache and pain down my neck, my stomach was upset along with fatigue. These feelings came and went throughout Sunday 10, Monday 11, and Tuesday 12. I felt better on Wednesday Jan 13th. On Sunday January 23rd I started feeling very fatigued, achy and had a fever of 100 F. This lasted through Monday Jan 24
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| 51 | 2021-02-03 | abdominal pain upper |
Hot feeling on arm. Itchy all over my body. Mainly on arms and trunk, ears face nose. neck head...
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Hot feeling on arm. Itchy all over my body. Mainly on arms and trunk, ears face nose. neck head . Heavy feeling in chest. Pain around ribs stomach area an hour after shot. Pain in area of shot. Headache and ache in shoulder of arm with shot. Back ache.
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| 51 | 2021-02-03 | abdominal pain upper, nausea |
Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps ...
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Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day jan 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day 15Jan 2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; over all not feeling well; Burning feeling around sternum area; Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; 2 hrs after vaccine. Felt like multiples needles like shooting to both side of sternum.; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 51-years-old non-pregnant female patient (nurse) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm from 14Jan2021 16:45 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital. The patient medical history was not reported. There were no concomitant medications. The patient had no allergies to medications, food or other products. Historical data includes patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), on 23Dec2020 at 16:00 in left arm for Covid-19 Immunisation. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 14Jan2021 (2 hrs after vaccine) the patient experienced felt like multiples needles like shooting to both side of sternum. No others symtoms. On the next day 15Jan2021 the patient woke up with flu like symptoms: aches. pain .nausea. tired. little stomach cramps needle like feeling, headache. little dizziness. over all not feeling well. Burning feeling around sternum area. No treatment was given for the events.. However, it was also stated 'Took 2 tylenol symptoms. Remains. I slept off most of the time.'. Clinical outcome of the events Felt like mutiples needles like shooting to both side of sternum, flu like symptoms: Aches. Pain .nausea. Tired. Little Stomach cramps needle like feeling.. Headache. Little dizziness. Over all not feeling well. Burning feeling around sternum area was reported as unknown
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| 51 | 2021-02-03 | difficulty swallowing |
Swelling of throat to uncomfortable point, but did not close. Hard to swallow. This occured withi...
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Swelling of throat to uncomfortable point, but did not close. Hard to swallow. This occured within an hour of injection
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| 51 | 2021-02-03 | nausea |
Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Headache-Severe, Systemic: Nausea-Se...
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Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Other- Dizziness, Feeling Faint-Severe; symptoms lasted 1 day
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| 51 | 2021-02-03 | nausea |
chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm...
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chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm is killing her; pain was in her body/whole body was killing her; not able to walk; whole body joint pain; feeling cold and warm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported), intramuscular on the left arm on 19Jan2021 10:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiry date not reported), intramuscular on the left arm on 29Dec2020 10:15 for COVID-19 immunization and experienced arm was sore and hurting. The patient reported that she just got the second dose of the vaccine yesterday (19Jan2021). She had a really bad side effects. With the first dose only her arm was sore and hurting, states it was nothing, she did not have side effects. With the second dose her left arm is killing her on 19Jan2021. She clarifies the side effects that she is experiencing are whole body joint pain and muscle pain on 19Jan2021, chills on an unspecified date, nausea on 20Jan2021, headache on an unspecified date, and she is very, very tired on 19Jan2021. She received the second dose of the vaccine around 10:15 am yesterday and she went to work and she was ok. About 12 hours later on 19Jan2021 she started feeling bad, by 10-10:30pm her whole body was killing her and she was not able to walk. Around 11:15pm she had to talk to her supervisor since she was not able to work. She was experiencing the whole body pain and muscle pain. She did not have nausea or dizziness last night. She could not sleep last night, she was not comfortable in bed since she was in pain, her pain was in her body. She started feeling dizzy and nauseous this morning (20Jan2021) when she was getting out bed. States she could not even drive, she wish she had someone that could have picked her up from work since it was horrible. She reported all night she was feeling cold and warm, yesterday she felt warm and she thought she had a fever and when she checked her temperature she did not have a fever. Her temperature this morning was 97.5. Right now she feels freezing, the chills. The patient underwent lab tests and procedures which included body temperature: 97.5 on 20Jan2021. The patient did not recover from her left arm is killing her, whole body joint pain, feeling cold and warm, muscle pain, nausea, very tired, and dizziness while the outcome of the rest of the events was unknown.
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| 51 | 2021-02-04 | diarrhea |
"Patient reports 8 days ago had first COVID vaccine. 4 days ago she had 2 episodes of diarrhea, 3 da...
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"Patient reports 8 days ago had first COVID vaccine. 4 days ago she had 2 episodes of diarrhea, 3 days ago HA. Better on Saturday. Yesterday and today every time she eats she had diarrhea. no fever/chills/body aches Tired today but up a lot of the past 2 nights due to her symptoms"
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| 51 | 2021-02-04 | nausea |
02/02/2021 at 11:30am breathing uneasy; I took Benadryl at home and slept for 10 hours. Pain to inj...
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02/02/2021 at 11:30am breathing uneasy; I took Benadryl at home and slept for 10 hours. Pain to injection site upon waking; I took Tylenol 8 hrs and drank 20 oz water. 02/03/2021 at 130am running nose and nausea started. At 9am I took some alka seltzer cold tabs. At 5pm I realized pain to right arm was worsening after full inspection I recognize swollen axillary lymph nodes; entire arm pit is swollen. I applied moist heat compress throughout the night and took more Tylenol. I hydrated with water and just layed around resting my body. 02/04/20 swelling continues with some decreased visible; pain to right arm pit continues and nausea continues.
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| 51 | 2021-02-04 | nausea |
Fever at max 39.7, body aches, chills, headache, nausea Severe lymph node swelling armpit on the sid...
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Fever at max 39.7, body aches, chills, headache, nausea Severe lymph node swelling armpit on the side of injection ( size of a ping pong ball)
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| 51 | 2021-02-04 | decreased appetite, nausea |
Headache, nausea, chills, muscles that feel they need to be stretched. Loss of appetite but no vomi...
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Headache, nausea, chills, muscles that feel they need to be stretched. Loss of appetite but no vomiting.. Signs started 12 hours post vaccine.
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| 51 | 2021-02-04 | nausea, vomiting |
Nausea starting a few hours after injection (the start date, upon further reflection, should be 2/1)...
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Nausea starting a few hours after injection (the start date, upon further reflection, should be 2/1). Nausea has continued to today (2/5). Vomitted first day, unable to eat much other than toast and ginger ale since. Periodic chills. significant fatigue. No fever. At time of submission, nausea is still occurring.
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| 51 | 2021-02-04 | difficulty swallowing |
about 10 minutes after receiving vaccine i got swelling of the tongue, mouth and a little hard to sw...
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about 10 minutes after receiving vaccine i got swelling of the tongue, mouth and a little hard to swallow , constriction of throat. i was given an epi pen and taken to Emergency at Medical Center. I was released a couple hours later. I ended up going back to Emergency later on that evening but to Hospital. Tongue started to swell up again and was getting constriction of the throat and hard to swallow. Got released a couple hours later
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| 51 | 2021-02-05 | vomiting, diarrhea, nausea |
I got my first round of the Pfizer vaccine on 1/14/21. On 1/27/21 I woke up feverish, with chills, b...
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I got my first round of the Pfizer vaccine on 1/14/21. On 1/27/21 I woke up feverish, with chills, body aches, diaherra and intense nausea. I went to Urgent Care on 1/28/21 and was tested for Covid, Influenza (A and B) and strep, all 4 tests came back negative/ not detected. I was told I had a viral infection and to be off work for 7 per symptoms. All of my symptoms worsened extremely over the next week. I went to Hospital on 2/2/21 after 3 days of no sleep, intense pain aches, headaches, and severe vomiting. They also gave me another Covid test that came back negative. The ER physician informed me that he thought my symptoms were too late to be considered an adverse reaction to the Pfizer vaccine.
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| 51 | 2021-02-06 | nausea |
First shot fine. Just a mild pain in arm day after. With the second shot I noticed lower back pain n...
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First shot fine. Just a mild pain in arm day after. With the second shot I noticed lower back pain night of shot started a couple hours after. Had fever and chills start in the night, Thursday. I woke up to awful body and joint aches everywhere the next day, Friday. On Friday I also lost sense of smell. Had nausea, couldn't eat, fever, sweats awful and some chills off and on. Saturday- not much body aches but sweating awful, very tired/drained feeling. Sunday (today)- still sweats and nausea.
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| 51 | 2021-02-06 | nausea, abdominal pain upper, abdominal distension |
Stomach pain, stomach swelling and nausea off and on. Started on Tuesday morning. Went to the Emerge...
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Stomach pain, stomach swelling and nausea off and on. Started on Tuesday morning. Went to the Emergency Room on Friday afternoon and was diagnosed with Pancreatitis. Sent home with pain and anti-nausea meds.
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| 51 | 2021-02-06 | nausea |
fever, muscle, some difficulty breathing related to muscle pain. Fatigue, nausea, headache. Decreas...
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fever, muscle, some difficulty breathing related to muscle pain. Fatigue, nausea, headache. Decrease some on day 2
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| 51 | 2021-02-07 | nausea |
Fever; Chills; Headache; Severe neck Pain; Muscle ache; Joint pain; Malaise; Fatigue; Nausea; Dizzin...
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Fever; Chills; Headache; Severe neck Pain; Muscle ache; Joint pain; Malaise; Fatigue; Nausea; Dizziness; Insomnia; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3302/expiration date: not provided), via intramscular route of administration, on 19Jan2021 04:15 PM (at the age of 51 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included Hashimoto's Thyroiditis and hypothyroidism. The patient had known allergies to levofloxacin, amoxicillin, levonorgestrel and ethinyl estradiol and pineapple. The patient previously received the first dose of BNT162B2 (lot number EJ1685) via intramuscular route of administration on 29Dec2020 at 04:15 AM (at the age of 51 years old), as a single dose in the left arm for COVID-19 IMMUNIZATION. On 05Jan2021, at 01:00 PM, the patient experienced headache, bodyaches, confusion, nausea, no appetite, fatigue, malaise, loose stools, joint pain, muscle pain, kidney pain, and watery eyes. The patient did not receive treatment for these events and has recovered from the events. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included thyroid (ARMOUR THYROID) and naltrexone. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines (besides the first dose of BNT162B2) within 4 weeks prior to the COVID vaccine. On 20Jan2021 at 04:00 AM the patient experienced fever, chills, headache, severe neck pain, muscle ache, joint pain, malaise, fatigue, nausea, dizziness, and insomnia. The patient did not receive any treatment for these events. The outcome of the events fever, chills, headache, severe neck pain, muscle ache, joint pain, malaise, fatigue, nausea, dizziness, and insomnia was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-02-07 | retching, nausea |
RN was called over to case, upon arrival, case was pale, diaphoretic, nauseated. Attempted to ask c...
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RN was called over to case, upon arrival, case was pale, diaphoretic, nauseated. Attempted to ask case name twice, she did not respond, case was began ?snoring? for roughly 3 breaths, then began dry heaving, which produced minute amount of blood tinged phlegm. At this time, case was able to tell me her name and was able to remember that she had just received her vaccine. Per her mother and guardian, case has history of mental disabilities and allergy to oral penicillin. Case also has history of childhood seizures that were so mild, she is not on medication. Case requested to be taken to ED for evaluation.
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| 51 | 2021-02-08 | abdominal pain, nausea |
yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 10...
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yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 105.00 with Tylenol; increased dizziness/light-headed; body aches; severe headache; nausea; chills; sweating/sweats; Fatigue; feeling crappy; blood pressure tends to be low but was 95/81 at the time she got the shot; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 25Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration on 19Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. Medical history included ongoing severe Crohn's disease, pneumonia, allergy to eggs/anaphylactic reactions to eggs, anaphylactic with bee stings on 2020 (this has happen twice in 2020), collapsed her lung (reaction to anesthesia that collapsed her lung), high fever, anaphylactic reactions. Concomitant medication included sertraline (SERTRALINE), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took Hep B and experienced fever, flu like symptoms, achy, and lethargic (no issue with the first 2 doses but with the 3rd dose she had a high fever); MMR and had an adverse reaction. It was reported that the shot was given on 19Jan2021. She experienced the following severe dizziness which started that day (17:45) and lasted 3 days. It has resolved. Nausea which started that day (17:45) and stayed constant for 3 days. Now it has only been happing in the late afternoons or evenings. Light headed which started that day and last 3 days. Headache (17:45), the initial headache felt like her whole head was going to explode into a 1000 piece. Now it just starts about 4-5pm in the evening. It was better and not as severe but like a migraine with nausea (17:45), feeling crappy (17:45), and body aches. Body aches which started on the day of the shot (17:45) and lasted 3 days. Fatigue which started on the day she got the shot (17:45) and was ongoing in the evening now chills and sweats which started on the day she got the shot and was ongoing. Her husband asked about if this was being related to the change of life but she doesn't think so. Fever which happened on the day she got the shot (17:45) but not at the site, later that night and was 105.00 with Tylenol. It has resolved. She noted that her blood pressure tends to be low but was 95/81 at the time she got the shot (17:45). The patient has not taken her blood pressure and does know if this has resolved. It was relayed that she took Tylenol and Benadryl before the shot due to her history and was still taking it as treatment for the symptoms. She has a lot of drug and other allergies, the only that was anaphylaxis was bees and egg. This was why she brought 2 EpiPens when she had the shot. She didn't have to use her EpiPen and was really proud of that but did have some reactions. The patient reported she did not go to the doctor. At this point she was somewhat expected that she had a not great reaction so the fact that she could still breath after getting it was a good thing. She also noted she could not have driven home due to dizziness. The patient was not brought to the emergency room and did not went to a physician's office. The patient has an ongoing medical history of Crohn's disease and reported that yesterday (as reported) started a flare up but she was not sure if this was related to the vaccine use. The patient recovered from fever on 23Jan2021; was recovering from dizziness, body aches, severe headache, nausea, chills, sweating, and fatigue; while outcome of blood pressure tends to be low, feeling crappy and Crohn's flare up was unknown.
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| 51 | 2021-02-09 | vomiting, nausea |
Nausea; vomiting; body aches; chills; constipation; cramping; swollen lymph nodes in neck and under ...
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Nausea; vomiting; body aches; chills; constipation; cramping; swollen lymph nodes in neck and under arms; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), intramuscular in the left arm on 22Jan2021 09:30 at a single dose for COVID-19 immunization. The patient's medical history included allergies to IV dye. The patient was not pregnant at the time of vaccination. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular in the left arm on 31Dec2020 09:30 at the age of 51 years old for COVID-19 immunization and codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 22Jan2021 10:00, the patient experienced nausea, vomiting, body aches, chills, constipation, cramping, swollen lymph nodes in neck and under arms. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
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| 51 | 2021-02-09 | vomiting |
Vomiting about 17 hours after shot; pressure in ears; aches; chills; This is a spontaneous report fr...
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Vomiting about 17 hours after shot; pressure in ears; aches; chills; This is a spontaneous report from a contactable other hcp reporting for herself. A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on the left arm on 23Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included vertigo from an unknown date and unknown if ongoing, food intolerance to raw eggs, red dye and bag lettuce from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]) and paracetamol (TYLENOL). The patient previously had the first dose of the vaccine on 06Jan2021 (lot number: EK5730). On 24Jan2021 09:30 AM, the patient experienced vomiting about 17 hours after shot. Also, pressure in ears and like many others aches and chills. No treatment was received for the events. The outcome of the event was recovering.
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| 51 | 2021-02-21 | difficulty swallowing |
Difficulty swallowing within minutes of vaccination. no progression of this symptom and also develo...
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Difficulty swallowing within minutes of vaccination. no progression of this symptom and also developed a mild headache to base of skull. chest feels a little tight. 12.5 mg of Benadryl given about 30 minutes in to observation. After another 50 minutes, headache gone, chest pressure less, and swallowing improved. patient advised to return to ED if symptoms returned or worsened.
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| 51 | 2021-02-21 | vomiting |
Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. Th...
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Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. They asked me what are my allergies and medical history. I couldn't remember - so had brain fog at that time. My left ear, face, and neck (left side of head) is numb at that time. The symptoms were the same for two hours. Memory remained fogged. An hour or so after the incident - I called the advice nurse from medical clinic and I did remember the doctor's name. Pain on head and numbness remained for days. My auto-immune system was stimulated my doctor said. Everything kept cascading down - now I'm on post surgery 9 days and I'm on disability. I went to ER on January 18, I was complaining of left sided numbness, vomiting, headaches. Facial numbness (left), mild headaches. Left sided headache progressed to (similar to prior migraine headaches) migraine like. January 29, I emailed my physicians (in between the 17th and 29th). On the 29th, I went to see the doctor - joints - really swollen and painful and I cannot walk. I was given steroid shots. February 2, - appt with neurologist. February - with Dr. - for painful swollen feet; Feb 10 - appt with Rheumotologist - Feb 10 with Dr - a Specialist - , as well. Right foot is swollen as well as the left foot at this time. Dr. - axperatated the right ankle -he said it was infected. February 11, Dr said I have infected joints and need surgery. They did surgery on February 13th. Dr. the surgeon . Had surgery at medical facility for infected ankle. February 15 - discharged home. Appt with surgeon on the 16th. Appt with Primary on the 19th. Appt with my Rheumotologist today. Discharged - with Home Health care; Physical and Occupational therapist and nursing. I have been on bedrest since discharge. I need maximum care. Tomorrow I have a appt with surgeon to hopefully remove cast and sutures on surgical site.
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| 51 | 2021-02-22 | abdominal pain upper, diarrhea, abdominal discomfort |
A little over 24 hours after my second dose I started to feel muscle aches, a fever of 102.4, headac...
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A little over 24 hours after my second dose I started to feel muscle aches, a fever of 102.4, headache, chills, fatigue, diarrhea, sweating, injection site pain, stomach pain and upset. I have been taking Tylenol and Ibuprofen to help with the aches and pains and NyQuil at night to help with fever and aches. It is helpful. I have been eating a BRAT diet and drinking a lot of vitamin water with 0 sugars.
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| 51 | 2021-02-23 | abdominal pain upper |
6 DAYS AFTER THE SHOT I GOT JOINT PAIN AND MUSCLE PAIN TO THE POINT OF NOT BEING ABLE TO WALK. HAD S...
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6 DAYS AFTER THE SHOT I GOT JOINT PAIN AND MUSCLE PAIN TO THE POINT OF NOT BEING ABLE TO WALK. HAD SEVERE STOMACH PAIN, CHEST HURT WAS NOT ABLE TO DRAW A DEEP BREATH. RAN A FEVER OF 102.5 OFF AND ON.
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| 51 | 2021-02-23 | nausea | Splitting headaches, extreme fatigue, nausea, feeling hot without fevers, joint and muscle aches. |
| 51 | 2021-02-24 | nausea |
1 hour past 2nd shot, I felt fatigue, dizziness, brain fog and mild nausea. Possibly 12 hours past ...
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1 hour past 2nd shot, I felt fatigue, dizziness, brain fog and mild nausea. Possibly 12 hours past the shot, I awoke with a massive headache, achy joints & muscles from head to toe, chills, sweating, congestion, sore throat, increased dizziness and weakness. This was similar, but not as severe, as the onset of Covid-19 symptoms I experienced on January 5, 2021. 30 hours past the 2nd shot, I am still experiencing aches, pains, dizziness, fatigue, and a headache I cannot alleviate with Ibuprofen.
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| 51 | 2021-02-24 | nausea |
Beginning three days after receiving my second Pfizer COVID-19 dose, I developed intractable nausea ...
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Beginning three days after receiving my second Pfizer COVID-19 dose, I developed intractable nausea that lasted for 10 days. That same day, I also developed extreme thirst, which persists today (22 days post-vaccine).
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| 51 | 2021-02-24 | nausea |
She did not have any reactions to the first dose; however, this dose made her feel lightheaded, dizz...
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She did not have any reactions to the first dose; however, this dose made her feel lightheaded, dizzy, and nauseas. She felt "off" to the point of tears. EMS took a look at her and her blood pressure was elevated. When she developed a rash the decided to transport her to the hospital for further evaluation. She was given Benadryl 12.5mg PO before she left the clinic. They started an IV for the patient but did not hook any medications or fluids up at the time.
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| 51 | 2021-02-25 | nausea |
At the vaccine administration location, patient experienced the following symptoms: tightness in che...
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At the vaccine administration location, patient experienced the following symptoms: tightness in chest, tightness in throat, nausea, ithcy tingley lips, burning lips, bumps/gives on inside of lips. Patient given diphenhydramine 25 mg oral solution PO x1. Vitals taken: WNL. Patient denied EMS transport to ER and transported self to ER. Per ED Provider Notes: Patient reports vaccine was given about 1.5 hours prior to arrival. Pt reported sensation of swelling of her arms, left eye itchiness, and itchiness on the inside of her lips. She denied any difficult, no abnormal sensation in her throat, throat swelling or swelling elsewhere in her mouth. Pruritus documented, no rash. Nausea. At the time of the ER provider examining patient. it is reported that patient was not having anaphylaxis but does have a flat appearing raised lesions on side aspect of upper lower lip. Pt treated with IV diphenhydramine, PO Prednisone and IV famotidine along with NS. Patient observed for 2.5 hours and then discharged. No swelling, itching or swelling and time of discharge and reports resolution of symptoms.
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| 51 | 2021-02-25 | nausea |
Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea...
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Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea; Slight headache; Right arm injection muscular pain radiating to elbow; This is a spontaneous report from a contactable Nurse. This 51-year-old female Nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3246), intramuscular at right arm on 25Jan2021 15:30 at single dose for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included HTN, cholesterol, known allergies: sulfa. Historical vaccine included the first dose of BNT162B2 (lot number=EJ1686) on 04Jan2021 13:00 via intramuscular at left arm for COVID-19 immunization. Concomitant medication included amlodipine, rosuvastatin calcium (CRESTOR), clonazepam. On 26Jan2021 12:00, patient had body aches, joint pains, chills, right arm injection muscular pain radiating to elbow, slight nausea, slight headache with outcome of unknown. No treatment was received. The patient underwent lab tests included COVID-19 virus test (nasal swab): negative on 10Jan2021. Patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination.
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| 51 | 2021-02-25 | vomiting, nausea |
had great amount of weakness to left leg that began evening of receiving vaccine dose. i also felt w...
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had great amount of weakness to left leg that began evening of receiving vaccine dose. i also felt weak, but left leg was extremely weak and just could not get much feeling in my leg.. also left foot numbness as well. headache increased over course of the evening and into the next morning. i alternated tylenol and advil to try and help with the headache beginning evening of receiving dose. by next morning i decided to take vicodin to help get the headache under control. i then began with vomiting late am on 2/06. had chills, headache continued, and headahce persisted. i also had very large amount of nausea that lasted until mid to late morning of 2/07. vomiting saturday am, afternoon, and evening. unable to keep any food or liquid down at all. swallowed 3 sips of gingerale saturday pm, and vomited within 5 minutes of it. feeling to my leg gradually returned to normal on saturday (vaccine was friday). i'm doing report mostly because of the left leg symptoms and vomiting. not sure if this should be reported, so i am just reporting it.
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| 51 | 2021-02-26 | nausea |
About 10 min after the in jection I started to feel nausea with a metal taste in my mouth. Then I st...
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About 10 min after the in jection I started to feel nausea with a metal taste in my mouth. Then I stared to get a headache and tremors in my hands and arms. After another 5 min I was getting mussel tightness in my face and throte. I started to get dizzy and feel very cold.
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| 51 | 2021-02-27 | diarrhea |
Elevated blood sugar levels beginning 6 hours after injection; Diarrhea multiple times 5 hours after...
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Elevated blood sugar levels beginning 6 hours after injection; Diarrhea multiple times 5 hours after injection; Fever of up to 102.5 starting 12 hrs after injection; Chills and shaking starting 12 hrs after injection; Very swollen and tender lymph node above clavicle noticed approximately 42 hours after injection; Muscle and joint pain
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| 51 | 2021-02-28 | nausea |
A little nauseated following injection. By that afternoon felt very ill. Took Tylenol and went to be...
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A little nauseated following injection. By that afternoon felt very ill. Took Tylenol and went to bed. Basically slept for the next 36 hours. High fever?Tylenol only brought down slightly and back up within a few hours, severe headache that Tylenol didn?t help, nausea to point of unable to eat or drink because felt like going to puke, dizziness whenever tried to get up, would also get short of breath whenever tried to get up, raised heart rate, fatigue?I was so out of it that my husband had to occasionally wake me to make sure I was still responsive, terrible body aches to the point that it hurt to move.
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| 51 | 2021-02-28 | nausea |
Headaches started within 10 hours of receiving second dose. I have had continuous headaches since 1...
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Headaches started within 10 hours of receiving second dose. I have had continuous headaches since 1/24/2021
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| 51 | 2021-02-28 | abdominal pain upper, nausea |
Stomach cramps; arm soreness; severe vertigo; nausea; unable to get up or walk; dizziness; Dose Numb...
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Stomach cramps; arm soreness; severe vertigo; nausea; unable to get up or walk; dizziness; Dose Number 2, Date of start of drug 21Jan2021/ Dose Number 1, Date of start of drug 29Dec2020; This is a spontaneous report from a contactable nurse (patient). A 51-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration on the left arm on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no allergies to medications, food, or other products. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: unknown) in the left arm on 29Dec2020 at 15:00 (3:00PM) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Jan2021 at 04:00, the patient experienced stomach cramps and arm soreness for two days. On the same day, the patient experienced severe vertigo with nausea and was unable to get up or walk. The following day, 24Jan2021, vertigo was slightly less. On the fifth day, the patient was still having some dizziness and nausea. No treatment was administered for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The events stomach cramps and arm soreness resolved in 25Jan2021, and the events nausea, unable to get up or walk and dizziness had not resolved, while the event severe vertigo was resolving.
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| 51 | 2021-03-02 | diarrhea, abdominal pain |
I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administratio...
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I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; left arm soreness onset evening of vaccine for about 1.5 days; This is a spontaneous report from a contactable nurse (also the patient). A 51-year-old female (also the age at vaccination) patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248), via an unspecified route of administration at the left arm on 07Jan2021 14:40 (also reported as 02:45 PM) at SINGLE DOSE for Covid-19 immunization. The patient was vaccinated at a Hospital. The patient is not pregnant at the time of the report. Medical history included Environmental allergies: some trees and grass (also reported as Known allergies: No). The patient had no COVID prior to vaccination. Th patient was not COVID tested post vaccination. No other vaccine in four weeks. Concomitant medication included (reported as Other medications in two weeks) bupropion hydrochloride (WELLBUTRIN), loratadine, pseudoephedrine sulfate (CLARITIN-D), montelukast sodium (SINGULAIR), diphenhydramine hydrochloride (BENADRYL), vitamin d nos (VITAMIN D NOS) and MVM (exact meaning unspecified). It was reported that: "Administration time on my paperwork was documented incorrectly; I received 07Jan2021 dose at 2:40pm and not the 1:40pm time that is documented. I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration (reported as 5:30 PM), lasting about 2 hours and resolved; left arm soreness onset evening of vaccine for about 1.5 days." The patient was not treated for the events. The outcome of the events was recovered.
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| 51 | 2021-03-02 | decreased appetite, nausea, vomiting, diarrhea |
Nausea vomiting diarrhea severe headache unable to eat so far for 3 Days cannot lift my head fever c...
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Nausea vomiting diarrhea severe headache unable to eat so far for 3 Days cannot lift my head fever chills. Severe internal ear pain and headache but it's not touched by Tylenol or Ibuprofen
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| 51 | 2021-03-03 | vomiting, diarrhea | Migraine, vomiting, intense injection arm pain ( unable to lift arm), joint pain, diarrhea |
| 51 | 2021-03-03 | nausea |
half hour - itchy mouth, dizzy, lightheaded, headache (30 mins) - BP surge 151/104 (2 hours after),...
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half hour - itchy mouth, dizzy, lightheaded, headache (30 mins) - BP surge 151/104 (2 hours after), chest tightness, heart racing (3 hours after) - some of this went away after a while - mostly subsided (still having some chest pains and racing heart off and on) - red blotchy face, hands, bit of nausea - 1 day following
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| 51 | 2021-03-04 | nausea | Lightheadedness and nausea |
| 51 | 2021-03-07 | nausea |
Patient has a history of anxiety and anaphylaxis to latex. She started feeling weird in head, nausea...
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Patient has a history of anxiety and anaphylaxis to latex. She started feeling weird in head, nauseated, and dizzy a few minutes after her vaccine. BP 153/96 with pulse of 101 5 minutes post vaccine. We continued to monitor her. 20 minutes post vaccination bp 136/89 with pulse 97. 30 minutes post vaccine we tried to sit her up. She was very nauseated. bp 144/99 pulse 85. 35 minutes post vaccination bp 140/108 and pulse 83. She felt sick with her IBS, and we got her into the bathroom via wheelchair. 50 minutes post vaccination, bp was 129/93 with pulse of 83. We called her husband to pick her up because she was exhausted after all of this.
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| 51 | 2021-03-07 | nausea |
dizzy; nauseous; sweating and sweated all night; fever of 99; achy; feeling cold/freezing; chills; T...
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dizzy; nauseous; sweating and sweated all night; fever of 99; achy; feeling cold/freezing; chills; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 51-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration on the left arm, on 03Feb2021 15:00, at single dose, for covid-19 immunization. Medical history included high blood pressure and, diagnosed with COVID-19. The patient has unspecified concomitant medications. The vaccine was received at the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 04Feb2021 around 12NN, the patient started feeling cold and chills. By 17:00 on 04Feb2021, she had fever of 99 and was freezing and achy. Around 20:00 on 04Feb2021, she started sweating and sweated all night. She felt better on 05Feb2021 around 14:00. On 06Feb2021 she got up, and then was dizzy and nauseous. At the time of the report, the patient was recovering from all the adverse events with no treatment received. The patient has not been tested for COVID-19 since the vaccination.
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| 51 | 2021-03-09 | nausea |
Fever at 102; Aches; Nausea; Chills; Headache; This is a spontaneous report from a contactable consu...
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Fever at 102; Aches; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 01Feb2021 at 07:15 AM, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin and diagnosed with COVID-19 prior vaccination. There were no concomitant medications. No other vaccine was administered in four weeks. The patient received the first dose of BNT162B2 on 12Jan2021 at 05:00 PM for COVID-19 immunization (in left arm). On 01Feb2021 at 05:00 PM (around 10 hours after the patient received the vaccine), the patient had symptoms including fever at 102, aches, nausea, chills, and headache. The patient was unable to go to work for 2 days. No treatment was received for the adverse events. The patient underwent COVID-19 test post vaccination that was negative on 04Feb2021. The patient recovered from the events in Feb2021. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
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| 51 | 2021-03-16 | appendicitis |
Acute Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 51-year-ol...
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Acute Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in the right arm on 23Feb2021 23:30 at a single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication included duloxetine hydrochloride (CYMBALTA). The patient did not received other vaccine in four weeks. The patient experienced acute appendicitis on 28Feb2021 00:00. The patient had an emergency open appendectomy. Outcome of the event was recovering. The patient was hospitalized for acute appendicitis for 4 days. Event serious due to hospitalization and life threatening. The event resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The patient was not diagnosed of COVID prior vaccination and has not tested for COVID post vaccination.
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| 51 | 2021-04-04 | indigestion, abdominal pain upper, vomiting |
Developed indigestion symptoms (stomach aches, vomiting) over night, hospitalized with small bowel o...
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Developed indigestion symptoms (stomach aches, vomiting) over night, hospitalized with small bowel obstruction on March 20, 2021, ended up having bowel resection surgery March 29th. No previous history of bowel obstructions or digestive issues.
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| 51 | 2021-04-12 | abdominal pain upper, diarrhea |
at 11:30 pm on 4/7/21 I had extreme, spontaneous, stomach cramps so bad I thought I was going to pas...
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at 11:30 pm on 4/7/21 I had extreme, spontaneous, stomach cramps so bad I thought I was going to pass out, that lasted for one hour, then diarrhea. A few hours later I started blood red rectal bleeding. At the hospital I was diagnosed with Ishemic colitis (from colonoscopy) and a blood clot was also found, portal vein thrombosis. I am 100% certain the extreme stomach cramps were brought on by the vaccine and that in turn caused the ishemic colitis, the blood clot may or may not have already been there. Note: The Dr.'s were not interested to tie any relation to this episode with the vaccine which was quite frustrating as it was quite obvious
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| 51 | 2021-04-12 | vomiting |
sudden severe onset of vertigo; dizziness; syncope; vomiting; This is a spontaneous report from a co...
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sudden severe onset of vertigo; dizziness; syncope; vomiting; This is a spontaneous report from a contactable consumer (patient, self-reported). A 51-Year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6204 and expiry date was not provided) via an unspecified route of administration, in left arm on 12Mar2021 at 13:30 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and immunotherapy. The patient had allergies to penicillin, sulfa drugs and peanuts. The patient's concomitant medications were not reported. The patient previously took ibuprofen and had allergy. The patient stated that On 18Mar2021 at 12:30, the patient experienced sudden severe onset of vertigo and dizziness with syncope and vomiting. The patient was hospitalized for 3 days. On an unknown date in Mar2021, the patient was hospitalized, and a week and a half later still had dizziness which prevents patient from performing daily tasks. Patient received unspecified treatment for the adverse event. Seriousness of the events was reported as hospitalization. Outcome of the events vertigo, syncope, vomiting and loss of personal information was recovering, and for the events dizziness it was not recovered.
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| 51 | 2021-04-20 | nausea, decreased appetite |
All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pa...
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All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pain; I had some wired nausea, I can even hardly eat; I had some wired nausea, I can even hardly eat; My heart rate is kind of low but it's been 125 for last 2 days; I have a rash; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; My lymph nodes are very swollen; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have been passed out; I had mine my fever gone up to 104.9 and down to 103; my arm is swollen, hard and hurts terribly; my arm is swollen, hard and hurts terribly; whole arm get deep red; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, in the left arm on 01Apr2021 (Batch/Lot Number: EN6199) (at the age of 51 years old) at a single dose for covid-19 immunisation. Medical history included lupus and high blood pressure both from an unknown date. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonazepam (KLONOPIN) and topiramate (TOPAMAX) all taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 12Mar2021 (lot number: EN6198) (at the age of 51 years old) and reported that she was really not feeling well. On 01Apr2021, the patient got the second dose of covid vaccination and reported that she had a pretty serious side effect since the first one. The patient then reported her fever gone up to 104.9 and down to 103 and reported that she was worried about herself, not only the fever; her arm is swollen, hard and hurts terribly; patient reported that all her muscles and whole body is hurting and the chills, the joint pain of course the fever and further reported that had some wired nausea, she can even hardly eat. The patient then stated that within a few hours after her shot, she started having mild problems: swelling of her arm, her whole arm get deep red and throughout pain in her arm. The patient had a video call with her primary care doctor, the doctor said it's just normal, don't worry about it, the doctor didn't let the patient give all her symptoms (as reported). The patient further stated she have that pain and something is not right in her body and that she have been taking Tylenol. The patient also reported that her heart rate is kind of low but it's been 125 for last 2 days (as reported), patient reported that she has a rash, feel dizzy and weak, cannot stand up and walk, the patient have attended to go for her family house for the Easter and she was there for 15 minutes. Keep in mind Covid normally they all were vaccinated and it's been a very special time, but within 15 minutes the patient have been passed out and had been taking home and further reported that her lymph nodes are very swollen and her head is killing her. The patient have an electric blanket in her arm because she have chills so bad, her joints are hurting and she have ray nods (as reported) also that's circulation disorder and she feel like she have been freezing cold ever since she got the second shot. The outcome of the events was unknown.
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| 51 | 2021-04-20 | nausea |
Bell Palsy; pain in arm; pain in neck; headache worsen from center of head to neck; dizzy; nausea; c...
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Bell Palsy; pain in arm; pain in neck; headache worsen from center of head to neck; dizzy; nausea; chills; tongue swollen; no taste; This is a spontaneous report from a contactable consumer (patient). A 51-year-old (also reported as 52-year-old) female patient received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 51-years-old, administered in Arm Left on 10Mar2021 10:45 (Lot Number: EN6202) as single dose for COVID-19 immunization. Medical history included asthma and high blood pressure. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced "Bell palsy", pain in arm, pain in neck, headache worsen from center of head to neck, dizzy, nausea, chills, tongue swollen, no taste; all on 19Mar2021 22:30. Description was as follows: "pain in arm, neck, headache, dizzy, nausea, chills and then days later other symptoms, headache worsen from center of head to neck, neck hurting, tongue swollen, no taste, and then woke up with Bell Palsy and was taken to the emergency room". Therapeutic measures were taken as a result of Bell palsy. The outcome of the events was recovering. The events were considered as serious (Disability or permanent damage/ Disabling/Incapacitating). The adverse events resulted in any Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. More information has been requested.
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| 51 | 2021-04-22 | nausea |
Painful body and joint cramps aches fingers arms hands legs feet toes neck hips shoulders. Mild he...
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Painful body and joint cramps aches fingers arms hands legs feet toes neck hips shoulders. Mild headache. Stomach nausea. Very tired
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| 51 | 2021-04-24 | nausea, decreased appetite |
My ears are ringing constantly; My eyesight changed and I can't see out of my glasses./vision is so ...
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My ears are ringing constantly; My eyesight changed and I can't see out of my glasses./vision is so bad I cannot drive; Eyes are blurry; Nausea; Couldn't keep food down; Dizzy; can't get balance; Couldn't sleep for five days; Sore throat; runny nose; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 (Lot Number: SJCFR EN 6199) on 24Mar2021 09:00 as single dose, and dose 2 (Lot Number: En6199) on 24Mar2021 (to be confirmed) as single dose, both via an unspecified route of administration, administered in left arm for covid-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID prior vaccination. She has not been tested for COVID after vaccination. On 31Mar2021, the patient reported that her ears were ringing constantly, her eyesight changed, and she couldn't see out of her glasses. Her eyes were blurry, and vision was so bad she cannot drive. She had nausea for a week straight. She also couldn't keep food down. She was dizzy and couldn't get balance. She also couldn't sleep for five days. She also had sore throat, and runny nose for a week. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and has caused disability or permanent damages. Treatment for the events included prednisone and anti-nausea medicine. The outcome of the events was not recovered.
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| 51 | 2021-04-24 | indigestion, abdominal pain upper, vomiting |
Small intestinal obstruction; vomiting; Indigestion; extreme stomach pain; don't feel well enough; T...
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Small intestinal obstruction; vomiting; Indigestion; extreme stomach pain; don't feel well enough; This is a spontaneous case is received from a contactable consumer reported for herself from a Pfizer Sponsored Program. A 51-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EP6955 and Expiry date: 30Jun2021) via an unspecified route of administration on 18Mar2021 as SINGLE DOSE for COVID-19 immunization. Medical history was not reported. The patient's concomitant medications were not reported. The patient did not have any adverse events prior to vaccination. Patient received the first dose of the Pfizer vaccine and had some adverse events front the first dose. She doesn't feel well enough to receive the second shot of the vaccine. On 18Mar2021 night patient experienced vomiting, indigestion, extreme stomach pain with the outcome unknown. Patient would like to reschedule her second dose if possible because she was hospitalized. On 20Mar2021 she went to the emergency room was diagnosed with small bowel obstructions and had surgery. She spent 10 days in the hospital and is currently recovering after the surgery of small bowel resection at the point of obstruction. She was released from the hospital on 1Apr2021. The patient underwent lab tests and procedures which included blood test: nil, x-ray: nil. Therapeutic measures were taken as a result of small intestinal obstruction (small intestinal obstruction). Additional information has been requested.
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| 52 | 2020-12-31 | nausea, difficulty swallowing |
Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my thr...
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Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my throat. I was taken to the ER. The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea and feeling very unwell.
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| 52 | 2021-01-01 | nausea | headache, chills, fatigue, nausea starting 1-2 hours after vaccine dose and lasting 7 days |
| 52 | 2021-01-02 | nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for a few seconds it - did not go past 15 minute observation. Felt nauseated for a brief time - did not go past the 15 minutes. About 25 minutes after the tip of my tongue, section of my bottom lip and sides of my tongue were tingly. The tip of my tongue continues to be like that day #2 after and there is a small blood blister underneath the tip of my tongue. Parts of my body feel a little itchy an hour after vaccine and continues very infrequently at this time and it disappears in seconds.
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| 52 | 2021-01-03 | abdominal discomfort, diarrhea |
Initially I had sore arm and very tired , which all resolved with in 24 hours of the vaccine. The...
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Initially I had sore arm and very tired , which all resolved with in 24 hours of the vaccine. The morning of the 26th (day 3 after vaccine) , I woke up and felt great.. I took my normal 4- 5 mile run. I felt a little dizzy , & hungry when I ran (not my normal) , got home had diarrhea 1 x , then for next two days very faint GI discomfort and I had fever for two days , temp range 99-100
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| 52 | 2021-01-03 | nausea | Nausea, headache, muscle ache, exhaustion, chills, low grade fever, and pain at the injection site. |
| 52 | 2021-01-03 | nausea, diarrhea, vomiting | Temperature of 103 F, nausea, vomiting, diarrhea for 3 days |
| 52 | 2021-01-04 | diarrhea, nausea, decreased appetite |
1/4/21 around 10am became extremely nauseated, clammy, dizzy and hot. No temp and had just received...
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1/4/21 around 10am became extremely nauseated, clammy, dizzy and hot. No temp and had just received COVID POC test and was negative. Left to go home and had loose stool then chills, body aches, hot spells, and extremely tired. Could not stay awake and was in brain fog. Slept all day, all night and all day on 1/5/21. No appetite, stuffy nose, headache, chills and hot spells, no fever, Again unable to stay awake.
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| 52 | 2021-01-04 | nausea | Nausea, lightheadedness, headache, fatigue, sore/swollen arm |
| 52 | 2021-01-04 | nausea |
chest tightness; 103.8; Fatigue; body aches; headache; nausea; This is a spontaneous report from a c...
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chest tightness; 103.8; Fatigue; body aches; headache; nausea; This is a spontaneous report from a contactable other healthcare professional (HCP). This 52-year-old female HCP reported for herself that she received 1st dose of BNT162B2 intramuscular at left arm on 28Dec2020 08:30 AM for Covid-19 immunization. Medical history included COVID-19 and concomitant drugs were not provided. The patient did not realize vaccine should be taken 90 days after a covid infection tested positive on 12Jan2020. The patient received vaccine on 28Dec2020, she experienced 103.8, fatigue, body aches, headache, nausea, and some chest tightness on 29Dec2020 at 09:00 AM. No treatment was received. The outcome of the events was resolving. The events were reported non-serious. Information about lot/batch number has been requested.
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| 52 | 2021-01-04 | nausea |
within 20 of the injection I strted to salivate and feeling nauseated. returned to clinic and was m...
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within 20 of the injection I strted to salivate and feeling nauseated. returned to clinic and was monitor there. my blood pressure was noted to be low at 115/41. HR 74. reepat BP was 121/48 which is much lower than my usal BP. i was observed for about 1 hrs. the sx's did not go away but the BP improved a little to 130/64 standing. I went home develop injection site pain, fatigue, headache and the pesistent salivation did not go away. after 1 wk it decreased in frequency but still present today. I can not do my normal activity as this worsen the symptom. and my blood pressure has not normalized. still run in 110's/60's. the headaches and fatigue are becoming a burden.
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| 52 | 2021-01-05 | nausea | Feeling unwell, tiredness, fever, chills, joint pain, headache. muscle pain. nausea |
| 52 | 2021-01-05 | abdominal discomfort |
Felt dizzy Racing heart with chest pressure Some difficulty breathing Clammy palms Placed me in ...
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Felt dizzy Racing heart with chest pressure Some difficulty breathing Clammy palms Placed me in supine position Observation maintained until vitals returned to normal
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| 52 | 2021-01-05 | diarrhea, nausea |
Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, n...
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Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, nausea, diarrhea, chest tightness, dry cough
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| 52 | 2021-01-05 | vomiting, abdominal pain upper, diarrhea, indigestion, nausea |
the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; t...
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the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; top of her stomach had a bad burning sensation; Vomiting; she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing; sore throat with a mild cough, like she needed to be clearing her throat; sore throat with a mild cough, like she needed to be clearing her throat; got a chill; food was not tasting right; arm was sore; could not raise her arm; her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unspecified route of administration on 21Dec2020 on left upper arm at a single dose for COVID-19 prevention. Current medical history included a lung disease called asthma and allergies, diagnosed in her late 20's; Diabetes Type 2, diagnosed about 10 years ago and High Blood pressure, diagnosed when she was in her 30's. Caller also wanted to include that she did have COVID before, she had COVID in Jul2020. Current concomitant medications included salbutamol (ALBUTEROL) at 2 Puffs via inhalation, twice daily for asthma; Unspecified Blood Pressure Medication One pill, once daily by mouth in the morning; Unspecified Nasal Spray 1 spray in each nare, once daily via nasal inhalation; montelukast sodium (SINGULAIR) at 1 pill via oral, once a day for allergies; metformin at 1 pill, daily, by mouth for Diabetes Type 2. The patient stated that her place of employment did not give her the card that has the lot number on it, they said they would give it to her with her second injection. The patient did not know the dose received, just that it was the first in the series. The patient had no other vaccines on the same day as the COVID vaccine. The patient reported that her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds. The patient received the vaccine on 21Dec2020, and as soon as she got the shot, her arm was sore like a flu shot. When she got the shot, she could not raise her arm past her shoulder without pain, but now she can raise her arm again. On Thursday, 24Dec2020, patient got a chill, and later that same night, food was not tasting right. On 25Dec2020, the chill continued, and she had a little bit of a sore throat with a mild cough, like she needed to be clearing her throat. On 26Dec2020 morning, the patient experienced vomiting when she woke up, and the top of her stomach had a bad burning sensation, and she had diarrhea. The patient stated that while she was vomiting, she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing. But the patient stated that she vomited, had diarrhea, and the burning sensation, the whole day on Saturday. The patient stated that on 27Dec2020, it calmed down, and she did not vomit at all. The patient stated that she felt like she needed to vomit, but she did not. The patient states that on Sunday, she still had the chills a little, and the top part of her stomach was still burning. The patient took some Pepto-Bismol and that helped calm down the caller's stomach. The patient stated that she could feel the Pepto-Bismol cooling her stomach off, like it had been hot, and patient stated that the top of her stomach felt swollen and gassy. The patient stated that later Sunday night, things calmed down, but she still has the burning sensation and she did not feel like she needed to vomit anymore. This morning, patient reported that she still has some burning sensation, but now, it is coming and going like labor pains. The patient stated that she did go to the bathroom once this morning and had diarrhea that was like liquid-y water. The patient stated that during all this over the last few days, each and every time that she tried to eat, she couldn't eat much because her stomach would burn more with eating. But yesterday, the patient had some fried fish and stated that the fried fish did not burn as much as the rest of the food she tried eating. The outcome of the events vomiting and the top of her stomach felt swollen and gassy was recovered on 27Dec2020, arm was sore and could not raise her arm was recovered on 26Dec2020, chills, top of her stomach had a bad burning sensation was recovering, Diarrhea/had diarrhea that was like liquid-y water was not recovered and other events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vomiting and Foreign body aspiration cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-01-06 | diarrhea | Diarrhea numbness of face/tongue Narrative: |
| 52 | 2021-01-06 | nausea |
Temperature 103.1, chills, muscle and joint pain, fatigue, weakness dizziness, headache, nausea rest...
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Temperature 103.1, chills, muscle and joint pain, fatigue, weakness dizziness, headache, nausea rest and fluids, acetaminophen started at 0400 am on 1/6 symptoms started to resolve by 2000 (8pm) on 1/6
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| 52 | 2021-01-07 | difficulty swallowing |
5 minutes after injection had internal thickening of throat and difficulty swallowing. After a coupl...
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5 minutes after injection had internal thickening of throat and difficulty swallowing. After a couple of minutes swallowing improved but throat thickening continued for another approximately 15 minutes. At 50 minutes after the injection had faint tingling around the mouth and mild throat internal throat thickening again. Took 25 mg of Benadryl. No further s/s.
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| 52 | 2021-01-07 | vomiting, abdominal discomfort | Chills, vomiting, fever 104, upset stomach, low energy level, headache |
| 52 | 2021-01-07 | nausea, diarrhea |
Diarrhea; Nausea; This is a spontaneous report from a contactable nurse. A 52-year-old female patien...
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Diarrhea; Nausea; This is a spontaneous report from a contactable nurse. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 29Dec2020 at 17:00 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none, and the patient had no known allergies. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 31Dec2020 at 12:30, the patient experienced diarrhea and nausea. The patient did not receive any treatment for the events. Since the vaccination, the patient had been tested for COVID-19 on 23Dec2020 (as reported) via nasal swab and the result was negative. The clinical outcome of the diarrhea and nausea was not resolved. Information on lot/batch number has been requested.
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| 52 | 2021-01-07 | diarrhea |
Dizziness, Headache, Myalgia & Diarrhea Narrative: Vaccinated in the morning 12/20. Fell asleep ear...
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Dizziness, Headache, Myalgia & Diarrhea Narrative: Vaccinated in the morning 12/20. Fell asleep early due to fatigue. Woke up not feeling well: headache, body aches, dizzy. Unable to go to work that day. By Tuesday able to return to work though experiencing loose stools.
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| 52 | 2021-01-07 | nausea | Fever, chills, nausea, lymph node enlargement with pain |
| 52 | 2021-01-07 | nausea | General Malaise, Light Headed, Palpitations & Nausea |
| 52 | 2021-01-07 | vomiting, nausea |
HEADACHE, NAUSEA, VOMITING, SYNCOPE, JOINT PAIN, WEAKNESS, EXTREME FATIGUE. STARTED ON 1-1-21, NAUSE...
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HEADACHE, NAUSEA, VOMITING, SYNCOPE, JOINT PAIN, WEAKNESS, EXTREME FATIGUE. STARTED ON 1-1-21, NAUSEA AND VOMITING STOPPED ON 1-2-21 BUT RETURNED ON 1-8-21.
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| 52 | 2021-01-07 | nausea, diarrhea | Low grade temp, chills, body aches, nausea and diarrhea, headache |
| 52 | 2021-01-08 | nausea, nausea | Headache, Myalgia, Fever, chills, arm pain, nausea, cough, fatigue, night sweats |
| 52 | 2021-01-08 | nausea |
Nausea, fatigue, hallucinations? Was under observation, emt was called, vitals were normal. Recove...
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Nausea, fatigue, hallucinations? Was under observation, emt was called, vitals were normal. Recovered within 3 hours with no further intervention.
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| 52 | 2021-01-08 | retching |
after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofra...
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after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofran 4mg, gave one dose epi-pen, and 50mg Benadryl. patient still complained of chest pain and was dry heaving. she was then transported by ems to the hospital at 4pm.
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| 52 | 2021-01-09 | nausea |
Headache hour after vacation, then as day progressed, continued headache, approx 4pm pounding heada...
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Headache hour after vacation, then as day progressed, continued headache, approx 4pm pounding headache, nausea, lightheaded, fatigue and just feeling bad. Next day dizziness, fatigue, headache and body aches. Symptoms continued with some shortness of breath. Nyquil taken at approx 5-6pm. 3rd day woke up had dizzy spell fell on the floor. Still having some fatigue lightheadedness and nausea.
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| 52 | 2021-01-10 | abdominal pain upper |
52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccin...
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52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions. Provider will follow up in a few days to check on the patient.
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| 52 | 2021-01-10 | abdominal pain upper, abdominal distension |
I woke up at 0500 the day following vaccine administration with moderate to severe intestinal crampi...
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I woke up at 0500 the day following vaccine administration with moderate to severe intestinal cramping. I have never had this feeling. This persisted at that level for the day. It continued albeit milder, for the next 36 hours. It is now Monday morning and I still have stomach pain. It is not accompanied by any nausea or diarrhea. I do feel some mild constipation and bloating. None of this is typical for me. I have had no changes in eating that I can correlate. No one else in my family has been ill.
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| 52 | 2021-01-10 | nausea |
Migraine headache began the next morning about 7am and increased as the day progressed including nau...
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Migraine headache began the next morning about 7am and increased as the day progressed including nausea and light sensitivity. Waves of nausea and headache continued into the next day. I had not had a migraine in over 2 years prior to this event. Treated with OTC Excedrin at first on Jan 10th, then when that was ineffective took butabital at lunch time and when that was ineffective took Maxalt with phenergan about 5p. The next day on Jan 11th, thought I was better but by 630a nausea returned in waves and headache began building again. Took Maxalt with phenergan about 930a and again at 9p.
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| 52 | 2021-01-10 | retching |
Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortn...
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Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortness of breath that night. Next day still had fever, severe body aches and cough got worse with shortness of breath. I did home nebulizer several times and started prednisone 40mg. 1/6/21 shortness of breath worsened to the point I couldn't talk, chest tightness with burning. Went into ED at hospital where they gave me another breathing treatment x 2, magnesium sulfate, IV solu medrol. They were going to admit me but I decided against it with all the covid patients.
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| 52 | 2021-01-11 | nausea |
Had pain at the injection site; tiredness; headache; muscle pain; chills; joint pain; fever; injecti...
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Had pain at the injection site; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; difficulty breathing; she has a bad cough; This is a spontaneous report from a non-contactable consumer. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration from 05Jan2021 to 05Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. In Jan2021, the patient reported all of the symptoms on the sheet including injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell. The reporter also stated that the patient had difficulty breathing, she stated that every few words she has to catch her breath and she has a bad cough. The outcome of the event was unknown. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
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| 52 | 2021-01-11 | nausea |
I woke up with chills and fever 12.5 hours after the vaccine. Fever lasted for 36 hours and went as ...
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I woke up with chills and fever 12.5 hours after the vaccine. Fever lasted for 36 hours and went as high as 102.4. Intermittent nausea and very tired.
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| 52 | 2021-01-11 | nausea |
Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - fir...
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Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - first neck and face then rash progressed to a diffuse rash over entire body. I was on my way home and drove to Er and was seen. I was given Zolfran, Pepcid Solumedrol, Benadryl and Epinephrin.
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| 52 | 2021-01-11 | nausea, diarrhea, abdominal pain upper, abdominal distension |
injection site hot and swollen, itching on left arm belly and face, tingling on upper lip, numbness ...
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injection site hot and swollen, itching on left arm belly and face, tingling on upper lip, numbness on tong, headache, pain on back of neck, body pain down the back, diarrhea, stomach cramps, very tired, nausea, stomach bloating
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| 52 | 2021-01-11 | nausea | nausea fatigue sweaty chills sore lymph nodes in neck |
| 52 | 2021-01-11 | nausea |
woke up at 4 am the day after vaccination with pain in injection site arm 8/10. Had general muscle/...
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woke up at 4 am the day after vaccination with pain in injection site arm 8/10. Had general muscle/joint pain that made it difficult to get out of bed. Nausea and low grade fever. Unable to go into work. Felt I was not able to get out of bed to even take medication. Fianlly took 600mg of ibuprofen at 1:30 p.m. Was able to sleep and at 4pm was able to get out of bed. Still felt very fatigued. Slept well then next night and felt 90% better the next morning. Feeling much better today. No s&s.
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| 52 | 2021-01-12 | nausea | developed headache, light headedness, nausea and fatigue |
| 52 | 2021-01-13 | difficulty swallowing |
About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I fel...
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About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I felt pain in my temple and I also felt like my ears were clogged. My tonugue was tingling and I had pain across my chest. I had trouble swallowing and taking a deep breath. The medical providers assessed me and since my heart was not racing and I did not have a rash all over my body, deemed I was okay. When I went home, I noticed a rash on my chest from my collarbone to my sternum and alongside my ears on my neck. My sister is an ER Doctor and I did a video conference with her. She had me take Benadryl. I have never had any reaction to any vaccine nor have I ever had to take Benadryl.
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| 52 | 2021-01-13 | abdominal discomfort |
I received the Pfizer #EL3246 Vaccine, exp 4/30/2021 on Jan 12, 2021 through the Health Department a...
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I received the Pfizer #EL3246 Vaccine, exp 4/30/2021 on Jan 12, 2021 through the Health Department and developed severe facial swelling, primarily around the right eye. The left eye has slight swelling. Please note: I had a previous reaction to Tetanus many years ago that included swelling. In addition, I have had headaches and gastrointestinal symptoms.
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| 52 | 2021-01-13 | vomiting |
Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/...
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Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/29 around noon she started feeling tachycardic (resting heart rate was 107-125 bpm). She vomited and felt anxious. Developed fever of 101.8 and was very achy. Day 2: low grade fever treated with ibuprofen. Day 3: fever free but dizzy feeling. Day 4: symptoms resolved. Of note, patient was 30 days out from having had COVID-19 at the time of vaccination. Patient states her course of COVID was "serious" but did not require hospitalization.
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| 52 | 2021-01-13 | diarrhea |
Loose bowels; headaches; dizziness; loose stool; upper back pain where the lungs are/Upper back pain...
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Loose bowels; headaches; dizziness; loose stool; upper back pain where the lungs are/Upper back pain; Sudden head rush; This is a spontaneous report from a two contactable Other Health Professional (one of which patient) received via Medical Information Team. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: 30Apr2021), via an unspecified route of administration in arm left on 30Dec2020 at single dose for COVID-19 immunization. The patient medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient's concomitant medication included amlodipine at 10 mg and rosuvastatin calcium at 20 mg, both from an unknown date and ongoing. The patient experienced headaches, dizziness, loose stool, upper back pain where the lungs are/upper back pain, all on 02Jan2021. The patient also experienced loose bowels on 03Jan2021 and sudden head rush on 30Dec2020. The patient underwent lab tests and procedures which included COVID-19 test which resulted negative on 06Jan2021. The patient outcome of headache, dizziness, loose bowels was recovering, the outcome of loose stools was unknown, the outcome of back pain and sudden head rush was recovered.
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| 52 | 2021-01-13 | nausea |
Nausea, headache, body aches and pains, fever of 100.7 orally and chills, chest pain, feeling of bu...
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Nausea, headache, body aches and pains, fever of 100.7 orally and chills, chest pain, feeling of burning at surgical scar site, malaise starting around 18 hours post injection and lasting about 14 hours. Minimal to zero relief with Ibuprophen, or Acetaminophen. No medical treatment required. Headache continues to persist but chronic headaches are part of normal history.
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| 52 | 2021-01-13 | nausea | Systemic: Anaphylaxis-Severe, Systemic: Nausea-Medium, Systemic: Fainting-Medium |
| 52 | 2021-01-14 | decreased appetite |
Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of b...
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Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of both of my hands with itching and warm redness in them both (I have pictures) Within an hour it began feverish red itching and slight burning on both of The undersides of my forearms. I was advised by the pharmacists on duty in the covid clinic site to use topical Benadryl cream and or take Benadryl by mouth if it worsened. I was told to seek emergency dept help if any signs of breathing issues presented. The next morning the itching was gone the redness subsided and the rash was markedly better but still raised in the tops of my hands. By 1030am on 1/12/21, I could not detect taste or smell at all. I was advised then to report to employee healthline for further instruction. I was told to leave work and proceed to our employee Covid swab testing drive thru facility for Covid testing and remain home for results the following morning on 1/13/21. At approximately 10am 1/13/21 I was confirmed positive for COVID-19 via the swab results. I was told to quarantine and given a return to work date of 1/24/21 as long as my symptoms were resolved. I am currently in home quarantine still suffering no taste or smell, muscle cramps in legs, thighs and back. Fatigue, Loss of appetite, sinus pressure and headache not relieved with medications.
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| 52 | 2021-01-14 | abdominal pain, decreased appetite, nausea |
I had no side effects after my vaccine on 12/24/20 until 1/8/21. On Friday, 1/8/21 at 830pm I began ...
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I had no side effects after my vaccine on 12/24/20 until 1/8/21. On Friday, 1/8/21 at 830pm I began with severe abdominal pain, low grade fever, nausea and loss of appetite. My abdominal pain persisted and worsened over the next 24-36hours. I presented to the ER on Sunday, January 10, 2021 at 8am with severe right lower quadrant pain, pelvic pain, nausea and low grade fever. I was promptly diagnosed with appendicitis and taken to the OR at approximately 2pm on the same day. In the OR my appendix was gangrenous, there was pus in the pelvic area nd fluid in my peritoneum. My appendix was not ruptured. My appendix was removed as well as part of the omentum. I remained in the hospital on IV Metronidazole and Ciprofloxacin for 2 days and was discharged on 1/13/21 at 9pm. I am continuing to recvoer at home on the same 2 antibiotics in oral form. I have a JP drain that is still in place. Of note I had two negative COVID 19 tests on 1/9/21 and 1/10/21. Both were PCR tests.
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| 52 | 2021-01-14 | vomiting, nausea |
Nauseous; threw up a little; she keeps falling down, has had 3 falls; hit her head; she has a huge b...
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Nauseous; threw up a little; she keeps falling down, has had 3 falls; hit her head; she has a huge bump on her face that is very painful; she cannot walk straight or without assistance anymore; Vertigo; Weakness in the muscles; a little arm soreness; Body aches; Chills; Could not sleep; Fever; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received the second dose of BNT162B2 (Pfizer BioNTech COVID-19 Vaccine), Batch/lot number: EK9231, Expiry Date: 31Mar2021, via an unspecified route of administration on 06Jan2021 09:00 at single dose in deltoid right for COVID-19 immunisation. Medical history included heart attack from Jul2019. Concomitant medication included diltiazem from 2019 and ongoing at 120mg tablet taken daily for abnormal heart rhythm she did not know of until had heart attack, acetylsalicylic acid (BABY ASPIRIN) from 2019 and ongoing at 81 mg tablet taken daily for heart attack. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 17Dec2020 for COVID-19 immunisation; she got the Flu vaccine every year and got shingles vaccine in Mar2020 for immunization. She did totally fine after receiving Flu vaccines and the Shingles vaccine. She had no side effects from the Flu vaccines except maybe a little arm soreness; she had arm soreness for a couple of days after the shingles vaccine; maybe a slight fever and took it easy. This Emergency Room Nurse (patient) received her second dose of Pfizer BioNTech COVID-19 Vaccine on 06Jan2021 around 9:00am. She went back to work, worked around 6-8 more hours that day and was fine. She went home and around 8-10 hours after she got the second dose on the evening of 06Jan2021 she had a little arm soreness and body aches. Last night all night she had chills; she could not sleep; fever. This morning: 07Jan2021 she was so nauseous that she got up and tried to get to the bathroom where she threw up a little. She reported as of 07Jan2021 she kept falling down: She fell in the bathroom this morning first when she was trying to get to the bathroom to throw up; During the second fall she was going on the stairs and fell, and hit her head; she had a huge bump on her face that was very painful now that she thought was from that second fall; and she had the third fall this evening; she cannot walk straight or without assistance anymore, she had been on the couch all day. She has had vertigo all day and weakness in the muscles. Chills was described as unbearable, heavy chills that she could not control. Fever: Temperature of 102-102.4 degrees Fahrenheit. The high fever hit around 3:00am on 07Jan2021. When her high fever hit around 3:00am she thought she would go to the emergency room but she did not want to scare her family so she stayed home and tried to pull through it. Today she took a Tylenol after she threw up this morning just to get through the day. Since she cannot walk without assistance or walk straight today that's the only lingering symptom that really worries her; she may go to the emergency room tonight if she did not get any better. She just did not want to scare her family and the emergency room was another copay cost so she really did not want to go to the emergency room at her workplace; but she may go there tonight and be kept overnight under observation. Prior to taking this second dose of Pfizer BioNTech COVID-19 Vaccine she was completely fine. She expected to have body aches, chills and fever; but she never thought the Pfizer BioNTech COVID-19 Vaccine would put her into a place where she is falling like this with the nausea and vertigo; she has never in her life had vertigo or falling like this. She reported she had no other vaccinations on the same date as Pfizer BioNTech Vaccine second dose. Has had no other vaccines in the recent past. She had never felt like this before with any other vaccines; she had never felt so weak in her muscles and never fallen down like this with any other vaccines. Seriousness criteria and outcome of all events unknown. The reporter considered all events were related to Pfizer BioNTech COVID-19 Vaccine.
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| 52 | 2021-01-14 | vomiting |
THAT EVENING BETWEEN 10-11 PM HAD A GRAND MAL SEIZURE AND WAS UNRESPONSIVE. TAKEN TO ER WHERE BLOOD ...
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THAT EVENING BETWEEN 10-11 PM HAD A GRAND MAL SEIZURE AND WAS UNRESPONSIVE. TAKEN TO ER WHERE BLOOD WORK WAS DONE AND CT SCAN. SENT HOME AROUND 6:30 AM ON JAN 1ST. (I DO NOT REMEMBER MUCH JUST WHAT MY FAMILY HAD TOLD ME) . I DO REMEMBER BEING SEVERLY SICK WITH VOMITING IN THE ER. CURRENTLY FOLLOWING UP WITH MY FAMILY MD AND HAVE MRI AND EEG TESTS SCHECULED WITHIN THE NEXT COUPLE OF WEEKS.
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| 52 | 2021-01-14 | nausea |
Woke up with moderate fatigue, nausea, more severe arm pain than day before; Woke up with moderate f...
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Woke up with moderate fatigue, nausea, more severe arm pain than day before; Woke up with moderate fatigue, nausea, more severe arm pain than day before; Felt sweaty/chills, neck lymph glands tender; Felt sweaty/chills, neck lymph glands tender; neck lymph glands tender; Moderate arm pain that night; This is a spontaneous report from a contactable Nurse (patient). A 52-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL1284), intramuscularly on 04Jan2021 16:30 at single dose for COVID-19 immunization. Anatomical Located at Arm Right. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication which the patient received within 2 weeks of vaccination included colecalciferol (VITAMIN D), tocopherol (VITAMIN E), magnesium, ibuprofen, paracetamol (TYLENOL). The patient previously took amoxicillin and experienced allergy. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient experienced Moderate arm pain that night on 04Jan2021 19:00 and woke up with moderate fatigue, nausea, more severe arm pain than day before on 05Jan2021. At 23 hours post injection on 05Jan2021, the patient also felt sweaty/chills, neck lymph glands tender. All symptoms gone at 48 hrs post injection. The patient did not receive any treatment for the reported events. The outcome of the events was recovered in Jan2021. This case reported as non-serious.
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| 52 | 2021-01-14 | nausea | light headed, fever, nausea, head ache, trouble breathing |
| 52 | 2021-01-15 | nausea |
11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms ...
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11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms of tingling, warmness, pressure, burning on her upper left chest. Nausea and dizziness 11:58 am - takes diphenhydramine 50mg, (2 capsules of 25mg) by mouth 12:02 pm - receives 1 dose of EpiPen autoinjector 0.3mg IM. 911 call 12:05 pm - reports feelings of tightening in her throat and receives 2nd dose of EpiPen autoinjector 0.3mg IM 12:10 pm - reports that tightening in her throat is relieving 12:15 pm - EMS arrives and is transporting her to the ER
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| 52 | 2021-01-17 | nausea |
Fatigue; pain at injection site Headache on Right side of head Severe Nausea Muscle and joint Pa...
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Fatigue; pain at injection site Headache on Right side of head Severe Nausea Muscle and joint Pain Temp 100.3 Chills Lasted 24 hr Slept and try to stay hydrated
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| 52 | 2021-01-17 | vomiting, nausea |
Patient received the 2nd dose covid 19 vaccine at 12:07 and at approximately 12:10 began to feel nau...
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Patient received the 2nd dose covid 19 vaccine at 12:07 and at approximately 12:10 began to feel nauseated. Patient immediately began vomiting copious amounts and had a decreased level of consciousness. Pt was responding to painful stimuli and then after a minute to verbal commands but remained with an altered mental status. HR tachycardia at 118 bpm, pulse oximetry initially 96 on room air. The rapid response team arrived, an IV was established, cardiac monitor placed, Oxygen at 15 lpm via non rebreather mask. Zofran IM given prior to IV being established. Zofran IV given next. Solumedrol given IV. Bolus of Normal Saline given. Patient transported to the emergency department via stretcher.
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| 52 | 2021-01-17 | difficulty swallowing |
Recipient had difficulty breathing, swallowing and chill. Patient did not want to use epi pen . Diph...
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Recipient had difficulty breathing, swallowing and chill. Patient did not want to use epi pen . Diphenhydramine 25mg was taken. Patient felt better for about an hour and started having the same symptoms. Another diphenhydramine 25mg was given. Patient was observed by the nurse at the facility until after 5:30 pm and was able to drive home.
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| 52 | 2021-01-18 | abdominal discomfort |
After having the vaccination, felt woozy, headache. Went to bed, up Sunday morning, about 1:30, 1:45...
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After having the vaccination, felt woozy, headache. Went to bed, up Sunday morning, about 1:30, 1:45 had sever headache, feverish, no energy, sick to her stomach. Monday morning, excessive heart rate. Did not go to work. Was pale looking. By Monday evening, felt better. Today, wasn't feeling 100% but did go back to work.
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| 52 | 2021-01-18 | diarrhea, nausea | Chills 3 Days, Dizziness 3 Days, Nausea and diarrhea 3 Days. |
| 52 | 2021-01-18 | nausea | Severe headache, severe muscle aches/pain, joint pain, fever102.9, nausea |
| 52 | 2021-01-18 | nausea |
constant nausea, extremely fatigued, malaise ever since injection. body aches, chills, numbness i...
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constant nausea, extremely fatigued, malaise ever since injection. body aches, chills, numbness in hands all went away but had them for over a week
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| 52 | 2021-01-19 | nausea | 99.9 fever. body aches. Joint pain. Headache, nausea, fatigue |
| 52 | 2021-01-19 | decreased appetite |
Had flu like symptoms along with the most extreme headache with tunnel vision and vertigo. Unable to...
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Had flu like symptoms along with the most extreme headache with tunnel vision and vertigo. Unable to pick head up off pillow for 2 days. Unable to eat or drink as well.
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| 52 | 2021-01-19 | retching |
Patient reported feeling unwell, dizzy, dry heaving. Patient was watched monitored and charge RN wa...
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Patient reported feeling unwell, dizzy, dry heaving. Patient was watched monitored and charge RN was notified. No additional intervention.
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| 52 | 2021-01-20 | nausea |
She woke up thinking she didn't sleep; Nausea; sore arm; was really tired; This is a spontaneous rep...
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She woke up thinking she didn't sleep; Nausea; sore arm; was really tired; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration at the right arm on 09Jan2021 at single dose for COVID-19 immunization. The patient had no medical history and there were no concomitant medications. The patient took the first dose of the Covid-19 vaccine and was fine. The lot for the first dose of the vaccine was EH9899. She received it on 19Dec2020 (at the age of 51 years). She took the second dose on Saturday (09Jan2021). She experienced nausea and had a sore arm on 10Jan2021. It was not death defying. She was also really tired on 10Jan2021. She was advised by her employer to report this information. She took some Tylenol and relaxed. She was no longer nauseated or tired. Her arm was not sore only tender. She woke up thinking she didn't sleep on an unspecified date. The patient added that her boss said she might have to be tested. The patient asked if that was something that she needs to do. The outcome of the events nausea and tired was recovered on 11Jan2021. The outcome of the event sore arm was recovering. And the outcome of the event "She woke up thinking she didn't sleep" was unknown.
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| 52 | 2021-01-21 | nausea |
52 yo female vaccinated 1-8-21 with Pfizer. No reaction. Then had massage yesterday and then today d...
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52 yo female vaccinated 1-8-21 with Pfizer. No reaction. Then had massage yesterday and then today developed chills and fever. 101.5 now. Also has rash on breast and stomach. Flushed. Headache, nausea and myalgias.
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| 52 | 2021-01-24 | nausea, decreased appetite | Fever of 99-99.5 body aches. Nausea. Lack of appetite. Next day swollen lymph nodes only left side. |
| 52 | 2021-01-24 | nausea |
Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and ...
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Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and shoulder became swollen; she also has something else going on in her shoulder; achy all over in her neck, arm, and shoulder; achy all over in her neck, arm, and shoulder; Felt sick to her stomach; her arm was sore that evening; This is a spontaneous report from a Pfizer Sponsored Program made from a contactable consumer (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK5730) at single dose on left arm on 23-Dec-2020 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; COPD (chronic obstructive pulmonary disease). Concomitant Medication was nothing new, her normal medication, she took vitamins, and high blood pressure medication. She had had no positive test for Covid prior to the vaccine, she had had no antibody test, she had had no issues with vaccine in the past. The patient experienced left arm swelling in Jan2021 and pneumonia on 08Jan2021. The patient worked in a hospital and received her first dose on 23Dec2020 and she was supposed to get the second dose today but she was not at work today. She was wanting to know if she should go ahead and take the second dose because her arm was still swollen. The product was the Covid vaccine. She stated that her arm was still swollen, when she got shot she was fine, her arm was sore that evening (Dec2020) and then nothing, then a weekend after new years her arm and shoulder became swollen (Jan2021) and she had been to the ER and the doctor thought the swelling was because of the shot, but she also had something else going on in her shoulder (Jan2021). So in the meantime she went to the ER and they took X rays, and they told her that she was starting to develop pneumonia. She was going back to work tomorrow, being that she was on the antibiotics now, still had swelling in the arm, and had pneumonia, should she still get the 2nd shot. She noticed the swelling Saturday after New Years. She was also achy all over in her neck, arm, and shoulder (Jan2021). She felt sick to her stomach, this was all the first Week of Jan2021. She went to the ER, she was not admitted and came home the same day. She went to the ER on 08Jan2021. 08Jan2021 was also when the pneumonia was diagnosed. The name of antibiotic she was prescribed was doxycycline. She started it on Saturday 09Jan2021, she was prescribed 100 mg 2 pills a day for 10 days. When they did the X ray, they said that the pneumonia had showed up, or she was just starting to get pneumonia. Patient stated that she didn't believe because they made a comment about the way she was laying however she had been taking the medication and feeling better. She was schedule for the second dose today. She did reschedule for Friday, and wanted to know if she should still get it. In the ER, they said it could have been a blood clot and so they did a scan to find blood clots but it was negative. The outcome of event pneumonia was resolving; events left arm swelling and shoulder became swollen was not resolved. The outcome of rest evens was unknown..
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| 52 | 2021-01-24 | abdominal discomfort, diarrhea |
headache with in 30 mins, 3 days later GI upset diarrhea, SOB LAsting 3days. now 17 day later petec...
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headache with in 30 mins, 3 days later GI upset diarrhea, SOB LAsting 3days. now 17 day later petechiae on abdomen abd burning pain (lymph nodes) in right underarm.
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| 52 | 2021-01-24 | nausea | headache, fever, chills, body aches, nausea |
| 52 | 2021-01-25 | difficulty swallowing |
Approximately 5-10 minutes after it was administered, I felt a weird sensation in my throat. I could...
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Approximately 5-10 minutes after it was administered, I felt a weird sensation in my throat. I could breathe fine, but it felt as if it was swelling and it felt weird to swallow. I didn't want to overreact so I waited a total of 30 minutes and symptoms subsided. My throat still felt weird, but I could breathe so I felt it was fine to leave. Symptoms subsided more once I got home 30 minutes later, but I took Benadryl. Symptoms eased completely and did not return.
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| 52 | 2021-01-25 | difficulty swallowing |
Extreme fatigue followed by swelling of lymph nodes, swelling of tongue, difficulty swallowing. Pati...
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Extreme fatigue followed by swelling of lymph nodes, swelling of tongue, difficulty swallowing. Patient took Benadryl 50mg and drank lots of water. Patient states she was severely dehydrated. Patient stated that she "should have probably gone" to the hospital but she did not. She did have an Epipen on her person if needed at the time but decided not to use it.
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| 52 | 2021-01-25 | difficulty swallowing |
premed with Benadryl 50 mg 0953 (due to reaction with first dose). vaccine received at 1046. 1049 th...
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premed with Benadryl 50 mg 0953 (due to reaction with first dose). vaccine received at 1046. 1049 throat thick and unable to swallow. 1050 epi pen administered by RN (monitoring people after receiving injection) and a rapid response called. Transferred to the ER. 1147 IV Benadryl 25 mg and IV methylprednisolone given. Monitored for 4 hours in the ER then released. Throat still mildly thickened at that time. Resolved by late evening.
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| 52 | 2021-01-26 | difficulty swallowing |
12:35pm patient states her tongue and lips are tingling - patient evaluated by provider - 12:40pm 25...
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12:35pm patient states her tongue and lips are tingling - patient evaluated by provider - 12:40pm 25mg benadryl given - patient observed 1 on 1 1:25pm patient states she can not swallow - epi pen administered per providers order 1:35pm patient states she is feeling better and symptoms are dissipating
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| 52 | 2021-01-26 | nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA: Shortly after receiving the vaccine patient stated they had ch...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Shortly after receiving the vaccine patient stated they had chest pain, shortness of breath, nausea, back pain, and sweating. On evaluation a mild systolic murmur and irregular heartbeat were noted. Patient was transferred to the emergency department where initial vitals were within normal ranges except for blood pressure 145/104 mmHg. No wheezing, vomiting, respiratory distress, or anaphylaxis noted. Patient administered aspirin, morphine, acetaminophen, diphenhydramine, ibuprofen, and ondansetron and symptoms resolved. Repeat vitals were within normal ranges and patient discharged to home stable.
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| 52 | 2021-01-26 | nausea |
States started with side effects that evening around 6pm. Symptoms include fatigue, nausea, tirednes...
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States started with side effects that evening around 6pm. Symptoms include fatigue, nausea, tiredness, body aches, feeling unwell. Calling for follow-up because it has been over 48 hours since the vaccine and she still has symptoms. Now having sinus pain and congestion. Advised to follow-up with PCP. Placed order for COVID. COVID test on 1/19/21 resulted negative.
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| 52 | 2021-01-27 | nausea, vomiting | Arm pain, nausia, vomiting, fatigue and slept for 18 hours straight. |
| 52 | 2021-01-27 | nausea |
Fever up to 103, chills, body aches, nausea. Treated with tylenol 500 mg rotating 2 hours with ibupr...
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Fever up to 103, chills, body aches, nausea. Treated with tylenol 500 mg rotating 2 hours with ibuprofen 200 mg, and zofran 4 mg for nausea. Symptoms began at 7 pm on 1/26 and starting feeling better 1/28 at 8am
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| 52 | 2021-01-27 | abdominal pain |
Moderate general body pain; Mild Headache; chills; Mild abdominal pain; received the first dose of b...
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Moderate general body pain; Mild Headache; chills; Mild abdominal pain; received the first dose of bnt162b2 on left arm/ left arm pain; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL3249, expiry date: not reported), via an unspecified route of administration, on 13Jan2021 07:00 PM at a single dose on left arm for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at a hospital. The patient did not receive other vaccines in four weeks. The patient did not have covid prior to vaccination. Medical history included Diabetic type 2 and HBP (high blood pressure). She had no known allergies. Concomitant medications (other medications in two weeks) included losartan 100mg qd (once a day) and escitalopram 10mg qd (once a day). On 13Jan2021 10:00 PM, the patient experienced moderate general body pain, mild headache, chills, mild abdominal pain, left arm pain. The patient had undergone laboratory tests and procedures which included: covid test type = Blood test, covid test name = Serology, covid test date = 16Jul2020, covid test result=Negative; covid test date = 05Aug2020, covid test type = Nasal Swab, covid test name = Nasopharyngeal, covid test result = Negative. The patient did not receive any treatment for the reported adverse events. Outcome of the events was not recovered.
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| 52 | 2021-01-28 | diarrhea |
Headache first, Injection site swelling, then hives in the middle of the night at injection site, wo...
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Headache first, Injection site swelling, then hives in the middle of the night at injection site, woke up with muscle aches everywhere, diarrhea started mid day, fever 100.4
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| 52 | 2021-01-28 | vomiting | Tightness in throat, hypertensive, tachycardia, hives on face and upper chest, vomitting |
| 52 | 2021-01-28 | nausea |
Vaccine was on Wednesday 1/27/21 at 8:30. Felt a little off and sore arm during the day Wednesday....
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Vaccine was on Wednesday 1/27/21 at 8:30. Felt a little off and sore arm during the day Wednesday. Started with some body ache during night ( approximately 13:30 a.m.) at sleep. Woke up at 5 a.m. with fatigue, significant nausea and a headache. Unable to go into work. Headache improved by mid day. The fatigue and nausea continued and gradually decreased, lasted until laterThursday evening. Returned to work at 6:30 a.m. on Friday.
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| 52 | 2021-01-30 | abdominal discomfort | Upset stomach, jittery feeling, mild headache |
| 52 | 2021-01-31 | diarrhea, nausea |
39 hours after I received 2nd injection, started with bad migraine (3x as bad as usual migraine), di...
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39 hours after I received 2nd injection, started with bad migraine (3x as bad as usual migraine), diarrhea, nausea, had temp of 99.5F for one day, fatigue.
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| 52 | 2021-01-31 | nausea |
5 minutes post vaccine: nausea and dizziness, hypoglycemia ( EMTs at immunization site offered ER, w...
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5 minutes post vaccine: nausea and dizziness, hypoglycemia ( EMTs at immunization site offered ER, went home) 30 minutes post: severe chills ( resolved after 3 hours) 30 minutes post: headache (resolved by 3rd day) 30 minutes post: severe hypersomnolence ( slept the remainder of that day and through that night) 30 minutes post: body pain ( felt like it was in my bones rather than muscular)resolved after 3rd day 3 hours post: injection site pain (lasted about 5 days)
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| 52 | 2021-01-31 | nausea |
Bouts of vertigo; Dizziness; Weakness; Nausea; This is a spontaneous report from a contactable nurse...
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Bouts of vertigo; Dizziness; Weakness; Nausea; This is a spontaneous report from a contactable nurse (patient). A 52-years-old female patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: e10142) via an unspecified route of administration on 13Jan2021 09:15 at single dose in left arm for COVID-19 immunisation. She received the first dose (Lot number: Ej1658) in left arm on 23Dec2020 06:30 PM for COVID-19 immunisation. Medical history included diabetes, hypertension. The patient was not allergic to medications, food, or other products. Concomitant medication included metformin, metoprolol tartrate (METPROLOL), triamterene, rosuvastatin, pyrvinium (TRU). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the 2nd dose on 13Jan2021, experienced weakness, dizziness and nausea at around noon next day (14Jan2021 12:00 PM) then at around 6:00 pm bouts of vertigo. Up to now 5 day after the onset dizziness and vertigo still present. The adverse events result in doctor or other healthcare professional office/clinic visit. No treatment received for events. Events outcome was not recovered.
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| 52 | 2021-01-31 | vomiting, nausea |
Chills & shaking-lasted 24 hours Severe congestion-lasted 2 days Throat swelling-this happened the s...
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Chills & shaking-lasted 24 hours Severe congestion-lasted 2 days Throat swelling-this happened the same time as the congestion started and made me feel like I could not breathe. It only lasted a few minutes. Fever of 102.9-fever lasted less than 24 hours Severe headache and body aches-lasted 72 hours Nausea and vomiting-could not even keep anti-emetics down. Lasted 48 hours. I know many of these effects are considered a normal reaction to the vaccine. However, the throat swelling and feeling like I could not breathe was concerning. It happened about 30 minutes after the chills/shaking started and right before I actually began to feel sick.
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| 52 | 2021-01-31 | diarrhea, vomiting, nausea | Elevated BP, tachycardia, nausea, vomiting, diarrhea, headache, fatigue |
| 52 | 2021-01-31 | nausea | Headache, Nausea, Fever, Body aches |
| 52 | 2021-01-31 | nausea |
In the evening - about 12 hours after vaccine, I got nausea - severe. It lasted throughout that whol...
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In the evening - about 12 hours after vaccine, I got nausea - severe. It lasted throughout that whole night (couldn't sleep it was so bad) until about 10:00 -11:00 morning. And then it went away on it's own. I didn't take anything from it. First dose I had felt extreme fatigue (and that was only symptom that lasted for the same amount of time or 12 hours more). Did not get fatigue with second dose.
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| 52 | 2021-01-31 | nausea | Nausea & Chills |
| 52 | 2021-01-31 | decreased appetite, nausea |
Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chil...
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Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chills and fever of 100.7 with episodes of sweating profusely. 1/19/21 Pt states fever continues, body aches, (L) axillary lymph node swelling, HA, Nausea and a episode of Tachycardia that she recorded temp. ranged 101-102.2. 1/21/20 Pt stated to have cont. fever 102.2, HA, BA, sweating and lymph nodes swelling from (L) axillary to back painful. Pt States on 1/21/21 cont. sweating loss of appetite, nausea, weakness, fatigue injection site pain, no redness, warm, and palpable lump. Pt stated 1/23/21 body aches and fever. Pt resting drinking fluids as tolerated and taking advil 400 mg PRN 4mg Zofran
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| 52 | 2021-01-31 | nausea |
initially felt very nauseated, later that day had cold chills, felt like she had a fever, always run...
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initially felt very nauseated, later that day had cold chills, felt like she had a fever, always runs 96.6, temp was 99.5, went to bed, woke up thru the night with 'restless legs' could not get comfortable, joint/body pains, fatigue, as of today 2/1/21 still has joint pains and restless leg syndrome, needs sleep aids, taking several supplements for inflammation, omega 3, turmeric, vit C, apple cider vinegar, Tylenol and Advil (starting to upset stomach), going to MD this week
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| 52 | 2021-02-01 | nausea |
fever 102.9; Severe joint pain; body aches; headache; chills; weird vivid dreams; nausea; This is a ...
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fever 102.9; Severe joint pain; body aches; headache; chills; weird vivid dreams; nausea; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL1284/expiration date: unknown), via an unspecified route of administration, on 16Jan2021 09:45 AM (at the age of 52 years old) as a single dose on left arm for COVID-19 immunisation. Relevant medical history was none. Historical vaccine history included first dose of BNT162B2 vaccine (Pfizer product) on 26Dec2020 (lot number: EL1284) on right arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), ergocalciferol (VIT D), ascorbic acid (VIT C) and Zinc. The patient did receive other vaccines within 4 weeks prior to the COVID vaccine. On 16Jan2021 05:30 PM, the patient experienced severe joint pain, body aches, headache, fever 102.9, chills, weird vivid dreams, nausea. No treatment was received. The outcome of the events severe joint pain, body aches, headache, fever 102.9, chills, weird vivid dreams, nausea was not recovered.
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| 52 | 2021-02-01 | vomiting |
passed out; hit chin on the sink; vomited; Fever; chills; This is a spontaneous report from a non-co...
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passed out; hit chin on the sink; vomited; Fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 at single dose on unspecified date for covid-19 immunization. Patient had one of the worst nights, fever/chills on 18Jan2021. Got up at 1:30 on 19Jan2021 to use the bathroom, passed out and hit chin on the sink. Then vomited. Still low fever. Patient didn't receive treatment for events. Outcome of all events was recovering. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report was considered as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 52 | 2021-02-03 | nausea, vomiting |
Starting about an hour after the 2nd dose was administered she began experiencing severe nausea and ...
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Starting about an hour after the 2nd dose was administered she began experiencing severe nausea and vomiting, increased BP 133/77, pulse 110, temp 98.8 F. Symptoms resolved over several hours.
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| 52 | 2021-02-03 | difficulty swallowing |
The patient developed dizziness, diffuse skin redness, mild facial itching dysphagia with a feeling ...
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The patient developed dizziness, diffuse skin redness, mild facial itching dysphagia with a feeling of swelling in the throat. She is not having shortness of breath, nausea, vomiting, diarrhea. Patient was given 10 mg of dexamethasone IV at 18:04, Benadryl 25 mg IV at 18:04 and epinephrine 0.3 mg IM at 18:12. Patient was observed for approximately 3 hours and discharged from the ED to home in stable condition.
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| 52 | 2021-02-03 | abdominal pain upper, difficulty swallowing |
allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vac...
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allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination. I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats. They evaluatedI started feeling better towards the end of last week. Additional information for Item 18: allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination. I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats. me for another 15 minutes and they recommended that I be evaluated in the ED. The right arm was noticed to be red. The injection site was painful. I was evaluated by the MD and given medications per their protocol (epi, Benadryl, famotidine, steroid). I was discharged home around 1830 (with a ride) after my throat seemed to be getting better. I was discharged with an Rx for steroids, blockers and and epi pen. Later that night at about 2200, I woke up with my face/scalp itching. I continued feeling achy, intense headache, hot/cold, foggy mind. I called in sick for my shift on 1/19. I returned to work on 1/20 with minor symptoms.I was evaluated by my MD on 1/21 and had minor expiratory wheezes (I have asthma). I seemed to be feeling better until Saturday and then stomach cramping/muscle cramping (noticeable on the right hand/injection side), bad headaches, fatigue have resumed. ; 2/2 I started feeling better towards the end of last week. Still feeling off but able to do my normal routines.
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| 52 | 2021-02-03 | retching |
feeling unwell; dizzy; dry heaving; This is a spontaneous report received from a contactable pharmac...
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feeling unwell; dizzy; dry heaving; This is a spontaneous report received from a contactable pharmacist. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 17:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included allergies to contrast dye, obesity, osteoarthritis (OA), hyperlipidemia and being pre-diabetes. The patient was not pregnant during the time of vaccination. Concomitant medication included atorvastatin, meloxicam and multivitamins. The patient did not receive any other vaccines within four weeks prior to BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient experienced feeling unwell, dizzy and was dry heaving on 23Dec2020 17:30. No treatment was given for the events. The reporter assessed the events as non-serious. The outcome of the event was recovered on an unspecified date.
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| 52 | 2021-02-03 | decreased appetite |
headache; dizziness; lack of appetite; extreme fatigue; tachycardia; swollen tongue; scratchy throat...
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headache; dizziness; lack of appetite; extreme fatigue; tachycardia; swollen tongue; scratchy throat; This is a spontaneous report from a contactable other hcp. A 52-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number=EK9231), via an unspecified route of administration on 08Jan2021 16:00 on Left arm at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, sero negative RA, Known allergies: Penicillin. Concomitant medication included amlodipine (AMLODIPINE). No covid prior vaccination. No other vaccine in four weeks. Adverse event: Initially the patient got tachycardia, swollen tongue and scratchy throat 08Jan2021 16:15. Next day (09Jan2021) extreme fatigue, headache, dizziness, lack of appetite. 10 days later, was still not better. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE treatment included: Prednisone, 40 mg for 5 days, Benadryl 25 mg 2 x d. Covid test type post vaccination (Nasal Swab) on 13Jan2021 and 15Jan2021, was negative. The event outcome was not recovered.
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| 52 | 2021-02-04 | abdominal discomfort, diarrhea, decreased appetite | Headache Body aches Fever Chills Sick stomach Diarrhea Fatigue Loss of appetite |
| 52 | 2021-02-04 | abdominal discomfort |
I received the vaccine after noc shift and woke up with aches, headache, dizzy, mild GI symptoms tha...
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I received the vaccine after noc shift and woke up with aches, headache, dizzy, mild GI symptoms that lasted for about 2 days. I used Tylenol, drank fluids and stayed in bed. Lost of pay 12 hrs
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| 52 | 2021-02-06 | diarrhea | Chills, headache, diarrhea, muscle aches and fever. Date 02/06/20121 @ 9:00 am |
| 52 | 2021-02-09 | nausea | Felt nausea immediately after vaccine on 2/10. This resolved without intervention in a few minutes. |
| 52 | 2021-02-09 | nausea |
History of similar reactions with each flu vac. and therefore she stopped taking flu vacs. 5 years a...
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History of similar reactions with each flu vac. and therefore she stopped taking flu vacs. 5 years ago. Developed nausea, lightheadedness, headache, and shortness of breath 14 min after vaccine. Vital signs stable on admission to observation area and heartrate regular with apical auscultation. Forty-five min after vaccine, began having some chest pressure and tingling in her arms. Her heart rate irregular at 68 bpm. Employee called her cardiologist who advised her go to the emergency room. No history of angioedema.
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| 52 | 2021-02-09 | diarrhea, nausea |
Joint swelling hands; nausea; diarrhea; body aches; first dose: 31Dec2020/second dose: 17Jan2021; Th...
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Joint swelling hands; nausea; diarrhea; body aches; first dose: 31Dec2020/second dose: 17Jan2021; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 17Jan2021 08:30 at single dose on the right arm for COVID-19 immunization. The patient's medical history was none. No other medications received in two weeks. The patient previously took first dose of bnt162b2 (lot number=EL1284), via intramuscular on 31Dec2020 09:30 at single dose on the right arm for COVID-19 immunization, took erythromycin and experienced allergies. No other vaccine received in four weeks. Facility type vaccine was hospital. Patient was not pregnant. The patient experienced joint swelling hands, nausea, diarrhea, body aches on 20Jan2021 01:00. No COVID prior vaccination. No COVID tested post vaccination. No treatment received. Outcome of the events joint swelling hands, nausea, diarrhea, body aches was recovering. Information on the lot/batch number has been requested.
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| 52 | 2021-02-11 | vomiting, nausea |
meniere's ringing in right ear; head felt fuzzy; unable to concentrate; Nausea; Vomiting; Vertigo; T...
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meniere's ringing in right ear; head felt fuzzy; unable to concentrate; Nausea; Vomiting; Vertigo; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN and Meniere's disease. Patient was not pregnant at the time of vaccination. Concomitant medication included amlodipine and hydrochlorothiazide. No other vaccine was received in the four weeks. The patient experienced head felt fuzzy, unable to concentrate, Meniere's ringing in right ear, nausea and vomiting, vertigo on 25Jan2021 10:30. Events resulted in emergency room/department or urgent care. Meclizine, IV Fluids, Maalox and Zofran were given as treatment for the adverse events. Outcome of the events was recovered. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.; Sender's Comments: The patient had medical history of Meniere's disease. The reported event was more likely due to underlying disease, and less likely causally related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 52 | 2021-02-17 | abdominal distension |
I had an abscess tooth that became infected; UTI; headache; stomach bloating; pressure and discomfor...
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I had an abscess tooth that became infected; UTI; headache; stomach bloating; pressure and discomfort; blood in my urine; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 18Jan2021 at 10:30 AM as a single dose for COVID-19 immunization. The patient had no relevant medical history. The patient ha d no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination, has not been tested for COVID-19 since the vaccination, and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine and also did not receive any other medication within two weeks of vaccination. The patient had a headache on 22Jan2021 for 5 days. She also had stomach bloating and pressure and discomfort on 22Jan2021. It was reported that when she saw blood in her urine, she went to a walk-in and was diagnosed with a UTI on 22Jan2021. She did 7 days of an antibiotic. Then on 30Jan2021, she had an abscess tooth that became infected. It was reported that the patient received antibiotics for both infections. It was reported that the events result in a doctor or other healthcare professional office/clinic visit and an Emergency room/department or urgent care. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
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| 52 | 2021-02-21 | abdominal pain |
02/20 Approx. 4:30pm: very sharp but steady pain in liver that subsided in about 5 minutes. 02/20 Ap...
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02/20 Approx. 4:30pm: very sharp but steady pain in liver that subsided in about 5 minutes. 02/20 Approx. 5:30pm: cramp type pain in spleen area that subsided in approx. 15 minutes. 02/20 Approx. 6:00pm: arm pain & swelling at injection site that slowly increased over time. 02/21: Arm pain increased - very painful, swelling, limited ability to move arm without pain. 02/22: At the time of this submission, the arm pain & swelling is not as bad - it's minor now.
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| 52 | 2021-02-21 | decreased appetite |
Within 15 minutes, left arm got got really cold - like ice. Lasted about 2 hours. The arm to the to...
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Within 15 minutes, left arm got got really cold - like ice. Lasted about 2 hours. The arm to the touch was warm but it felt like it was in ice bucket. They kept me for 2 hours. Started to resolve in those two hours but didn't go away completely. By evening it was mostly returned to normal. Next day, I woke up with flu-like symptoms - felt like I had the flu. Every hair on my head hurt; wanted to sleep; no appetite. Three in afternoon - I felt much better. As quickly as it came on, it went away quickly.
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| 52 | 2021-02-22 | vomiting, nausea |
I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER w...
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I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER with a 103.5 fever lasted for 10 days, Covid test, Epipen,swollen lymph nodes(right arm) painful,increased fatigue.During the 10 day period I had went to the ER again 5th day got tested for Covid and rechecked symptoms.
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| 52 | 2021-02-22 | nausea |
Patient is a 52 year old female who presents with concerns of headaches, nausea, fatigue, hives/itch...
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Patient is a 52 year old female who presents with concerns of headaches, nausea, fatigue, hives/itching, and SOB since receiving her Covid-19 vaccine 3 weeks ago. Got the Pfizer vaccine at the Center on 1/17/21 around 12:30PM. She had no side effects during the 15 minutes she was kept for observation after receiving the vaccine. She did develop a headache and fatigue approximately 1.5 hours after she got the vaccine and then later that day developed nausea. SOB developed the following day. She developed hives on her chest approximately 2-3 days after the vaccine. States she cannot recall the exact date that the hives started. Hives have appeared like pink raised plaques. Largest plaque was 1 inch in diameter she estimates. The hives have continued to come and go from different areas of her body including her shoulders, buttock, upper legs. SOB is present at rest and with exertion. She has had no chest pain/pressure/tightness/wheezing , palpitations, or feeling of her throat closing. States her exertion capacity is reduced.
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| 52 | 2021-02-22 | nausea | Strong headache, in the left arm and all over the body. Nauseas Chills Dizziness |
| 52 | 2021-02-22 | nausea |
nausea, fatigue, headache used otc acetaminophen 500mg 2tabs q 12hours & headache gone morning 2 ....
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nausea, fatigue, headache used otc acetaminophen 500mg 2tabs q 12hours & headache gone morning 2 ... night 3 of nausea, took ondansetron 4mg i had from old RX once and otherwise, tolerated the little nausea left until gone night 4..brain fog for 4 days- remained without remaining headache
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| 52 | 2021-02-23 | difficulty swallowing |
Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swal...
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Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 26Jan2021 (09:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included anemia and allergies. Concomitant medications included an unspecified allergy shot. The patient was not pregnant at the time of vaccination. On 26Jan2021 (12:15), the patient had felt pains; lymph nodes had swelled; had pain on tongue; extreme dehydration; fatigue; and difficulty swallowing. The patient had received diphenhydramine (BENADRYL) as treatment for the events, and drank lots of water. The outcome of the events, 'felt pains', 'lymph nodes swelled', 'pain on tongue', 'extreme dehydration', 'fatigue' and 'difficulty swallowing', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.
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| 52 | 2021-02-23 | decreased appetite, abdominal pain upper |
Strong, prolonged and persistent headache. Pain and upset stomach, inappetence. Generalized pain in ...
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Strong, prolonged and persistent headache. Pain and upset stomach, inappetence. Generalized pain in bones and joints. Fever. Pain and swelling in the armpit of the arm where I was vaccinated.
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| 52 | 2021-02-27 | nausea | SOB, chest pain, numbness, tingling in mouth, nausea, weak. Cleared by EMS |
| 52 | 2021-02-28 | nausea |
Numbness of lips and tongue, paresthesias in upper extremity, nausea; LIP, and AMR gave Zofran and b...
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Numbness of lips and tongue, paresthesias in upper extremity, nausea; LIP, and AMR gave Zofran and breathing technique - reaction resolved. Extended monitoring was provided.
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| 52 | 2021-02-28 | diarrhea | Severe diarrhea, chills, lack of balance, weakness, arm pain. Pain in the back of my head. |
| 52 | 2021-03-01 | abdominal distension |
Within 15 minutes the right side of my face became itchy. My tongue also felt a weird sensation. B...
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Within 15 minutes the right side of my face became itchy. My tongue also felt a weird sensation. By 12:30 am that night my chest became itchy and I had red bumps on my chest, then around 2 pm the next day my stomach began to get itchy and red with a red bump.
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| 52 | 2021-03-02 | decreased appetite |
I slept all day; I could not eat; I could not get out of bed, I hurt so bad/Body aches; Muscle spasm...
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I slept all day; I could not eat; I could not get out of bed, I hurt so bad/Body aches; Muscle spasms; Headache; Tired; I had a 100.4 temperature for 2 days; This is a spontaneous report from a contactable consumer (reporting for herself). A 52-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 29Jan2021 to 29Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unspecified indication. On 30Jan2021, the patient stated that "I slept all day, I could not eat, I could not get out of bed, I hurt so bad and has body aches, muscle spasms, headache, tired and I had a 100.4 temperature for 2 days." The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Nov2020. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 52 | 2021-03-03 | diarrhea, vomiting, nausea |
Day 1, 26 Feb 2021; headache began at noon; severe fatigue at 6:00 pm; 103 degree fever at midnight ...
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Day 1, 26 Feb 2021; headache began at noon; severe fatigue at 6:00 pm; 103 degree fever at midnight Day 2, 27 Feb 2021: 103 fever for 3 hours, reduced and maintained at 100 with alternating extra strength Tylenol with 800 mg Motrin every 4 hours; continued severe fatigue; continue headache, nausea started at 5:00 pm Day 3, 28 Feb 2021: Nausea, diarrhea, muscle pain, vomiting, headache, 100 degree fever for 24 hours, 6:00 pm passed out for less than 1 minute when standing to go to bathroom to vomit (aware, controlled fall); 2nd episode of passing out sometime after midnight, tried to stand, completely blacked out, woke up disoriented, called 911, transported to ER; bruised upper left arm, left side jaw/neck hitting furniture in fall, hit head on floor
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| 52 | 2021-03-04 | nausea |
PATIENT REPORTED FEELING DIZZY AND LIGHT-HEADED WITHIN TEN MINUTES OF RECEIVING VACCINE. SHE FELT NA...
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PATIENT REPORTED FEELING DIZZY AND LIGHT-HEADED WITHIN TEN MINUTES OF RECEIVING VACCINE. SHE FELT NAUSEATED AND STATED SHE FELT LIKE SHE DID WHEN SHE HAD AN ALLERGIC REACTION TO A BEE STING THAT REQUIRED AND EPI-PEN. WE BEGAN ASSESSING THE PATIENT FOR ANAPHYLAXIS. WE GAVE DIPHENHYDRAMINE 50 MG ORALLY AND MONITORED HER HEART RATE AND BLOOD PRESSURE. HER BLOOD PRESSURE AND HEART RATE STAYED WITHIN NORMAL RANGE FOR THE NEXT 45 MINUTES. SHE REPORTED NO ANGIOEDEMA OR ANY OTHER SYMPTOMS OF ANAPHYLAXIS. WE ALSO ADMINISTERED FAMOTIDINE 20 MG TABLET. SHE CONTINUED TO DO WELL AND DID NOT EXHIBIT ANY OTHER SIGNS OF ANAPHYLAXIS. AFTER 45 MINUTES OF MONITORING THE PATIENT WITH SYMPTOMATIC QUESTIONS FOR ANAPHYLAXIS, MONITORING HER BLOOD PRESSURE AND HEART RATE, AND WITH NO OTHER SIGNS OF ANAPHYLAXIS, THE PATIENT WAS RELEASED FROM OBSERVATION. SHE REPORTED TO OUR PHARMACY ON 3/5/21 THAT SHE HAS CONTINUED TO HAVE SEVERE MUSCLE CRAMPING, SOME NAUSEA AND OVERALL FATIGUE. I COUNSELED THE PATIENT TO CONTINUE TO MAKE SURE SHE CONTINUES TO STAY WELL HYDRATED. SHE CONSULTED WITH MD AND HE ADVISED HER TO STAY HYDRATED. SHE ALSO TOOK PREDNISONE PRESCRIBED FOR A PREVIOUS KNEE INJURY, THAT THE PATIENT REPORTED.
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| 52 | 2021-03-04 | nausea, vomiting |
Within an hour I started feeling a little dizzy. At around 5:30 PM I was extremely nauseated and ev...
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Within an hour I started feeling a little dizzy. At around 5:30 PM I was extremely nauseated and even threw up a little. I had fever and chills. Next day still really nauseated. Nausea lasted about four days. Tired feeling for about 4 days. I'm still having days in which I get a nauseated wave hit me.
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| 52 | 2021-03-04 | nausea, vomiting |
aggravated and upset; she is angry; is miserable everyday/ felt like she was in a car accident, that...
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aggravated and upset; she is angry; is miserable everyday/ felt like she was in a car accident, that is how bad she felt; cold chills; she runs low like 96.6 to 96.8 and she took her temperature/ she was 95.5; joint pain/joint hurting; restless leg syndrome; fatigue; she got sick; nauseous; threw up; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included seasonal asthma diagnosed when she was a child and has a rescue inhaler she only uses once in a while if she needs it; she stated her thyroid was giving her problem, she takes a thyroid medicine; and stated weight was thanks to menopause. Concomitant medications included ascorbic acid (VITAMIN C), fish oil (OMEGA 3), and curcuma longa (TURMERIC). The patient reported that she was aggravated and upset on an unspecified date. She reported that she was not feeling bad before taking the shot and nobody was telling her what to do about it. She was asking what she should do about her symptoms of joint pain, restless leg syndrome and fatigue after getting her first vaccination on 22Dec2020. She was crying and stated that her boss can't tell her anything, she doesn't want to go to her doctor because, what was he going to tell her. She doesn't want to waste a copay. She reported taking Advil and Tylenol for her joint pain without relief and asked what else she should do. She stated she wanted directions, she doesn't want people reading off of a card. She stated she shouldn't have to pay a copay and she doesn't want more medicine to mask her symptoms, she wanted an answer. Additionally, the patient was calling about Pfizer COVID shot, she took first dose 22Dec2020, had a reaction, 35 minutes after she sat for 30 minutes, she works at a hospital, and she walked out to her car, she got sick and nauseous, then after the shot, she had flu like symptoms that lasted, and the next day was terrible, it lasted another week and a half, then she took the second shot 11Jan2021, to this day, she still has restless leg syndrome, fatigue, and her joints were hurting her. She had the same thing before, but this hurts a lot worse, and it was not going away, she was taking Turmeric, everything, and everyone says to just keep taking Tylenol or Advil but she can't keep taking it because now it was upsetting her stomach, or like arthritis medicine, she was taking Omega 3, vitamins, she was 52 years old, she does Spartan races, Cross fit, she does paleo and keto eating, if one looks at her they wouldn't know she was 52, and she was hurting everyday and doesn't know what else do to, and doctors weren't knowledgeable, she doesn't want a stupid answer. She called work, the CDC knows about it, now VAERS, and they said to call Pfizer, when she calls her doctor she doesn't want to pay a copayment and get an idiotic answer. She got this because she works at a hospital and she was trying to protect herself and everyone else, she doesn't like feeling this way, it was to the point she was getting angry, not at Pfizer, but she gets up and runs, with her dog, she was busy all the time, she has 3 boys in the military, and she meets up to do obstacles with them, but she doesn't feel like doing crap and was miserable everyday. She was a CNA in nursing school. She doesn't know if she even wanted to see her doctor, she doesn't want to get an idiotic answer. She hasn't seen him in while, she switched insurance, been primary for years. Stated this was her first day speaking to DSU before she decides what else to do after this, she was angry. Stated about 35 minutes after the first shot, after 30 minutes they said she could go, she said ok, she walked out to her car, was nauseous and threw up and didn't eat that morning, and the next day, she felt like she was in a car accident, that was how bad she felt, she had cold chills, flu like stuff that night before, she runs low like 96.6 to 96.8 and she took her temperature, she got in a blanket and went to bed that night, she was 95.5, and didn't bother taking another temperature, she took a bunch of Advil and went to bed, and Benadryl to go to sleep. This all started on 22Dec2020, and it took about 2 weeks, she just had joint pain, not like now, but those days she didn't feel good, but by the third week she was ok, and she went to take the second shot next time, and all hell broke loose. The second shot was 11Jan2021, and that night it she noted her joints were starting all over again, and she had restless leg syndrome, cold chills and everything, so she went to bed, she didn't have Benadryl, so she got up, and that night took Tylenol, she didn't get very much sleep, and she was very annoyed the next day, she felt like the first time, that like she got it an accident, feeling terrible, that night, and she can lay on the couch to relax, but with the restless leg syndrome, and her joints all day long, she just went yesterday to buy Advil Arthritis, and she never had arthritis before or anything. Restless leg syndrome depends, sometimes it was better than other time. Joint pain was not improving, she was so aggravated about that, she was not feeling 100%, people look at her and say she doesn't look like she feels good, she doesn't, and she was ready to bite their heads off, she was very active, always in the gym or something, she has 3 kids in the military, and was always meeting up with them to do military runs and just this was ridiculous. Stated she took a picture of the vaccine card, as she sent it to a few people. This was definitely the Pfizer vaccine, she has told many people, many people know do not take this, she was so irritated, it's not even funny. The case was reported as non-serious. The outcome was not recovered for the events joint pain, restless leg syndrome and fatigue; and unknown for the rest of the events.
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| 52 | 2021-03-06 | difficulty swallowing |
After receiving the shot about 30 seconds later I felt a gush of warm heat overcoming my body.With i...
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After receiving the shot about 30 seconds later I felt a gush of warm heat overcoming my body.With in a minute my throat got scratching and had a hard time Swallowing. My Tongue Swelled and my lips felt Numb.A Medic doc was called over to me. I was immediately taken to a tent with other Doctors. The doctor immediately gave me a Epipen in my right upper thigh. With in a few minutes EMS was there they tried to put a IV IN me but was unsuccessful. The EMT gave me a shot of Benadryl in my right arm. EMT rushed me to Emergency room. At the ER they put an IV in and gave me Dexamethasone and Pepcid. I was closely watched and was released after around 5 hours.
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| 52 | 2021-03-09 | nausea, vomiting |
glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side...
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glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side; vaccines were given in the left arm because she was left-handed; Back pain; spasms; fever; she felt like the inside of her eyes were on fire; She had a moist cough; spine pain; nausea; vomiting; She had numbness and tingling around the outside of mouth; She had numbness and tingling around the outside of mouth; She had pain in the arm at the injection site; knees would buckle; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302) at single dose on 27Jan2021 via an unknown route in left arm for Covid-19 immunization. She was diagnosed diabetes six years ago (as of 23Feb2021), and her last A1C was 6.1 in Dec2020, had chronic edema since her last child was born 26 years ago. Concomitant drugs included furosemide (LASIX) 400 mg twice daily, potassium 10 meg three times daily, omeprazole (PRILOSEC) 40 mg once daily, and metformin hydrochloride (METFORMIN ER) 1000 mg twice daily, all ongoing. She did not feel like the medication she takes are relevant because she had been taking them for a very long time. Historical Vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140) intramuscular injection in left arm on 04Jan2021 for Covid-19 immunization and experienced back pain, diagnosed with COVID in between the first and second vaccine, headache, arm pain at the injection area, severe back spasms in the thoracic and lumbar (AER 2021200627). Patient experienced back pain 2-3 days after the first dose, headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given Voltaren and Flexeril. She was taking 1 gram of Tylenol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. The reporter assessed headache, arm pain at the injection area, back pain, severe back spasms in the thoracic and lumbar were related to suspect vaccine. After the 2nd dose of the vaccine, patient experienced back pain in Jan2021, sharp, stabbing, crushing pain and spasms in Jan2021, fever for a couple of days in Jan2021, knees would buckle in Jan2021, glands were swollen and when swallows, sharp pain on one side on 09Feb2021, felt like the inside of her eyes were on fire in Jan2021, moist cough in Jan2021, spine pain in Jan2021, nausea and vomiting in Jan2021, numbness and tingling around the outside of mouth in Jan2021, pain in the arm at the injection site in Jan2021, injection site was about a silver dollar size and was red and warm to touch in Jan2021. The event clinical course was as follows: The second dose was given on 27Jan2021. She was getting over COVID and had to wait until the 27Jan2021 to get second dose. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021 with results of her PCR test on 13Jan2021. She was diagnosed with COVID in between the first and second vaccine due to an exposure not the vaccine. At hour 25 after receiving the second dose symptoms started. Severe back pain in the entire spine. It was sharp, stabbing, crushing pain and spasms. When the back would spasm her knees would buckle. She had a fever for a couple of days. 102 fever and she felt like the inside of her eyes were on fire. She has never had that before. She had a moist cough and still has a moist cough. The spine pain was better, but it is not gone away yet. Normally she does not have back pain. At first the pain was an 8 out 10 now (as of 23Feb2021) it was 5 out of 10. Also had nausea and vomiting. She had numbness and tingling around the outside of mouth. That lasted for two days. She had pain in the arm at the injection site. The injection site was about a silver dollar size and was red and warm to touch. She had pain at the injection site and pain in the arm. Both vaccines were given in the left arm because she was left-handed. She thought she would be using that arm more. She did go to Urgent Care after the second dose as well. They gave her a shot of Toradol and another prescription for Voltaren twice a day and Flexeril at bedtime because she can't stay awake when she takes it. She has missed work because of this. The back pain and cough was almost a month now (as of 23Feb2021). She reported no matter what she did she did not get it to go away. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of Tylenol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She has been taking 1000mg Tylenol three times a day and now she was taking it two times a day. She used Tylenol and generic, SunMark Acetaminophen (Lot number: OLE2349B, expiry: Sep2022). Regarding seriousness of headache, made a different in the vision. It was throbbing. for back pain: it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor. for arm pain at the injection area: gripping was not easy and moving her arm was painful. She is left handed. Heat worked better than ice. Ice made things worse. for cough: it had not been disabling. it was irritating because it had been almost 30 days. She knows it was different than the COVID cough because it was moist and when she had COVID it was a dry cough. Regarding seriousness of nausea and vomiting: it was debilitating and she couldn't go anywhere because she was throwing up with every move she made. The pain made it worse. The reporter assessed moist cough, nausea and vomiting, arm pain at the injection area were related to suspect vaccine. No investigation assessment performed. Outcome of fever, inside of her eyes were on fire, pain in the arm at the injection site was resolved. Outcome of back pain, moist cough was not resolved. Outcome of spine pain was resolving. Outcome of the other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the back pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including spine CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-03-09 | decreased appetite |
no appetite for 2 weeks; extreme itching in hands, feet, scalp; Severe fatigue; This is a spontaneou...
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no appetite for 2 weeks; extreme itching in hands, feet, scalp; Severe fatigue; This is a spontaneous report from a contactable other hcp (reporting for herself) A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose left arm on 18Jan2021 for covid-19 immunisation. First dose was administered intramuscular on left arm on 28Dec2020 17:15. Medical history was none. The patient's concomitant medications were not reported. The patient experienced severe fatigue on 25Jan2021, no appetite for 2 weeks on an unspecified date, extreme itching in hands, feet, scalp on an unspecified date. It was reported to be unbearable, and she was treated with Medrol dose pack, now Atarax, and prednisone (higher dose) and still have uncontrollable itching with only relief at night. The events outcome was not recovered. Information on the lot/batch number has been requested.
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| 52 | 2021-03-17 | nausea |
Nausea; tiredness; headache; injection site tenderness; feeling unwell; chills; fever waves; This is...
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Nausea; tiredness; headache; injection site tenderness; feeling unwell; chills; fever waves; This is a spontaneous report from a contactable consumer reported for self. This 52-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 16Feb2021 11:00 AM in left arm for COVID-19 immunization. Medical history included HBP (Blood pressure high); thyroid issues; obesity; known_allergies: seasonal allergies; covid-19. Concomitant medications the patient received within 2 weeks of vaccination included levothyroxine, losartan, HCTZ, vitamin D NOS, paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced nausea, tiredness, headache, injection site tenderness, feeling unwell, chills/fever waves on 16Feb202112:00 PM. There was no treatment received for the adverse event. This was a non-serious report. The events did not result in death, not life threatening, not caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. The outcome of events was unknown. Information on the lot/batch number has been requested.
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| 52 | 2021-03-20 | difficulty swallowing |
SEVERE VESTIBULAR STROKE. Complete occlusion. Patient is now in Rehab trying to regain her ability t...
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SEVERE VESTIBULAR STROKE. Complete occlusion. Patient is now in Rehab trying to regain her ability to swallow properly, see without double vision, and walk again.
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| 52 | 2021-03-24 | nausea |
Flushing face, heavy tongue, light rash left arm, stomach irritation (nausea).Patient developed a re...
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Flushing face, heavy tongue, light rash left arm, stomach irritation (nausea).Patient developed a reaction to COVID-19 vaccine 5 min. after injection administration flushing face, heavy tongue and light rash and nausea were the symptoms showed up by patient. V/S BP 198/886, P-63, Sat. 99%. Patient transferred to Hospital to get medical care and be under observation.
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| 52 | 2021-03-24 | difficulty swallowing |
I felt my throat closing up, making it more and more difficult to swallow or breathe; my throat felt...
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I felt my throat closing up, making it more and more difficult to swallow or breathe; my throat felt like a mild cold; more difficult to swallow; difficult to swallow or breathe; hives on my neck; swollen face and neck; swollen face and neck; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 12:00 (Batch/Lot Number: EN 620H) as single dose for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient previously took polio vaccine for immunization and experienced allergy, nickel and experienced allergy, chloroxylenol and experienced allergy, cetirizine hydrochloride (ZYRTEC) and experienced allergy, clarithromycin (CLARITIN) and experienced swelling face. The patient stated that, "After the vaccine was administered (18Mar2021 12:00) my throat felt like a mild cold making it a little more difficult to swallow. As I was sent to the high risk area I was monitored by a nurse. Upon leaving I got into my car that was warm inside. As I was driving I felt my throat closing up, making it more and more difficult to swallow or breathe. I went to a (store) and spoke to the pharmacist there. She advised me to take Benadryl immediately. She noticed hives on my neck and a swollen face and neck. As Benadryl took effect the hives receaded and the swelling of my face and neck went down. I went back to the vaccination site and seemed medical attention from the (Department name) Department team. They checked my vital signs and released me after a waiting period without any further medication being administered. I was given an appointment for 08Apr2021. I am concerned about an adverse reaction at the second appointment. Is it better to wait a little longer for the second dose to be given?" Patient is not pregnant. Therapeutic measures were taken as a result of the events included Benadryl. Outcome of the events was resolving.
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| 52 | 2021-03-28 | vomiting, nausea |
By the evening of the first day: Severe headache, face pain, neck pain( both muscle and nerve), neck...
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By the evening of the first day: Severe headache, face pain, neck pain( both muscle and nerve), neck tension, left and right arm pain and tingling, pain and tingling in left leg( mild). Talking hurt my face, smiling hurt my face. Being in any position where my arms hung down at my sides hurt everything above my mid back. Took 200 mg of Gabapentin. This allowed me to sleep. At noon on Mar 21, starting taking Ibuprofen, 800 mg 3x daily. After most of a week of doing little other than sitting and reading, the pain seemed to subside somewhat. Sat Mar 27th evening : increase of upper body pain after small amount of light work with arms followed by nausea and vomiting. Visited Emergency room. Blood tests were taken. The tests were normal. Vomiting subsided after doses mof anti-nausea medication for 24 hours. Nausea has not returned. Started taking 500 mg of Methocarbamol nightly. Started taking Tylenol 3 x daily on Mar 28 Presently: The pain in my left leg has gone except for the foot pain that I have lived with for 2 years. The left leg tingles mildly once in a while. All other pain is nearly the same. I am unable to do much more than type or sit and read. If I look down to do a task, after a few minutes, I get a sharp nerve pain in my face, head, and neck. The skin on the back of my neck has been mildly numb for several days.
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| 52 | 2021-03-31 | nausea |
pinprick blood rash all over/ diagnosed as immune thrombocytopenia; rash on chest and neck; fever; c...
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pinprick blood rash all over/ diagnosed as immune thrombocytopenia; rash on chest and neck; fever; chills; headache; body ache; joint pain; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female (not pregnant) received the first dose (dose number 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202) via an unspecified route of administration in the left arm on 15Mar2021 08:15 AM at a single dose or COVID-19 immunization. Medical history included Hashimoto's disease, pulmonary hypertension, obstructive sleep apnea, dermatomyositis. Concomitant medication(s) included escitalopram; tramadol; levothyroxine; all from Mar2021 (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had allergy to morphine. The patient was seen in the Emergency Room at a hospital on 20Mar2021 for pinprick blood rash all over the body on 16Mar2021; a doctor diagnosed it as immune thrombocytopenia from the Covid vaccine received 5 days earlier. On 16Mar2021, she had also been experiencing rash on chest and neck, fever, chills, headache, body ache, joint pain, fatigue, nausea for the past 5 days. The adverse event(s) result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the events included prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
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| 52 | 2021-04-06 | abdominal pain upper |
severe upper abdominal pain after eating; This is a spontaneous report from a contactable consumer (...
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severe upper abdominal pain after eating; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 16:00 (Lot Number: EN6202) (at age 52 years old) as single dose for covid-19 immunisation in the student health clinic. Medical history included MS and transverse myelitis, and peanuts allergy. The patient was not pregnant. The patient had no covid prior to vaccination and was not tested post vaccination. Concomitant medications included lamotrigine; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and ocrelizumab (OCREVUS); all taken for an unspecified indication, start and stop date were not reported. The patient previously received the dose 1 BNT162B2 administered in right arm on 01Mar2021 16:00 (Lot Number: EN6202) (at age 52 years old) for covid-19 immunisation. No other vaccine was given in four weeks. The patient stated that she is not sure if this is related to the vaccine, but it's the only thing she has done differently. The day after her vaccine, on 20Mar2021, she had severe upper abdominal pain after eating. Then on day 2 (21Mar2021), she had another bout of unbearably severe pain (10/10) after eating. She went to ER and had a CT scan & ultrasound. The patient was given IV fluids, pain meds, and antacid. Outcome of the event was recovered with lasting effects.
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| 52 | 2021-04-06 | abdominal pain, nausea |
weakness; nausea/her stomach is kind of queasy; She spent 2 days in bed, unable to get out to do any...
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weakness; nausea/her stomach is kind of queasy; She spent 2 days in bed, unable to get out to do anything other than pee, get something to eat and go back to bed; brain fog; she can't concentrate, it is affecting her head; dizziness/dizzy; exhausted/tiredness/tired; faint episode; achy arm; abdominal pain; her sugars really shot up in couple of hours, went to 220s; shivers, cold.; shivers, cold.; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [22Mar2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 18Mar2021 (at the age of 52-year-old) at single dose for COVID-19 immunization. Medical history included Diabetes, ongoing PoTS diagnosed around Dec2020 or Jan2021, MTHFR (methylenetetrahydrofolate reductase genetic mutation) genetic mutation, Genetic/Chromosomal abnormalities and lost some weight. The patient had prediabetes for long time, in last year gotten little bit bad; back under control sugars running 125-130. That's not why she is feeling like this. Measures her sugar 3 times daily keeps Diabetes diet controlled mostly. With regards to her MTHFR: methylenetetrahydrofolate reductase genetic mutation. This genetic mutation makes her not methylate well, they told her she is a poor meythelator. Family history included diabetes and high blood pressure. Her dad passed away from either Diabetes or Lung cancer; she is not sure which-he had lung cancer but afterwards when patient talked to her sister, sister mentioned dad's diabetes got really bad after the chemo and everything; but that is neither here nor there in the end; it could have been from Diabetes or lung cancer. He was a smoker for his entire life, even though chemo he could not quit the cigarettes, could not give it up even on his death bed. Concomitant medications included ergocalciferol (VIT D), cyanocobalamin (VIT B12), and ongoing ascorbic acid (VITAMIN C); all were taken for vitamin supplementation. The patient previously received varicella zoster vaccine rge (cho) (SHINGRIX) on 19Feb2021 for immunization and experienced achy arm and tired for a day. About 15 years ago when having her daughter, the patient had severe reaction to Magnesium sulfate for preeclampsia. They gave her Magnesium sulfate twice which made her comatose twice, she does not know why they gave it to her the second time. She also had a reaction to calcium levomefolate (DEPLIN), like a methylfolate thing. She reported she was on Glimepiride for Diabetes previously which was stopped a couple of weeks ago because she was having a lot of blood sugars that did not sit well with her. This consumer is the patient who called regarding symptoms she experienced following first dose of Pfizer-BioNTech COVID-19 Vaccine administration on 18Mar2021. The first symptoms she had were an achy arm later on that day of 18Mar2021. On 19Mar2021, the next morning she woke up totally exhausted. She spent 2 days in bed, unable to get out to do anything other than pee, get something to eat and go back to bed. Some of the symptoms lifted yesterday, 21Mar2021 during the day. She kind of got up, was still kind of tired but pushed through it thinking she couldn't just sit in bed. She spent a little time outside while her daughter was at the pool; she was sitting in a chair away from other people. When she came home she was really tired and dizzy on 21Mar2021 and decided to go to bed. The patient also experienced weakness and nausea on unspecified date. After the Pfizer BioNTech COVID-19 Vaccine injection/shot on Thursday, 18Mar2021 she had a faint episode. They thought the faint episode was probably from anxiety, reason unknown; but she had a lot of faint episodes before she went to bed. She woke up 1-2 hours later on 18Mar2021 with really bad abdominal pain all night, shivers, cold. When she got up in the morning she was really tired; she had to take her daughter to school and barely drove to school half-way coherent because her daughter was talking to her. She was not doing great, she came back home, she is still tired, has been on the couch all day; her stomach is kind of queasy, not good. This is day 4 so she is concerned a little bit. She is too tired to go downstairs during this call; this thing is kicking her butt; she is having a brain fog with this thing, she can't concentrate, it is affecting her head. She has other medical condition Diabetes: After she got the Pfizer-BioNTech COVID-19 Vaccine her sugars really shot up in couple of hours, went to 220s on 18Mar2021; sugars back down the next day (19Mar2021). She is terrified of what is going to happen after the second dose of Pfizer-BioNTech COVID-19 Vaccine. She verified she has not had any visit to physician's office, emergency room or hospitalization related to these events; not yet, but she is considering whether to go or not. The outcome of the event exhausted/tiredness/tired was not recovered, and the outcome of the remaining events was unknown. Information about the Lot/batch number has been requested.
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| 52 | 2021-04-13 | nausea, vomiting |
PT VOICED SHE TOOK PFIZER VACCINE THIS PAST FRIDAY (4/9/21). LATER THAT EVENING SHE BEGAN HAVING COV...
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PT VOICED SHE TOOK PFIZER VACCINE THIS PAST FRIDAY (4/9/21). LATER THAT EVENING SHE BEGAN HAVING COVID-LIKE SYMPTOMS AND RIGHT SIDE CHEST PRESSURE (ON/OFF). ON 4/12/21 SHE BEGAN HAVING NAUSEA AND VOMITING AND COULDN'T KEEP ANYTHING DOWN SO SHE DECIDED TO CALL HER PCP. SHE WAS ADMITTED TO THE HOSPTIAL ON 4/13/21. PT VOICED SHE DIDN'T HAVE ANY PROBLEMS OR SYMPTOMS BEFORE SHE RECEIVED THE VACCINE.
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| 52 | 2021-04-14 | difficulty swallowing |
Client was in observation for 15 minutes after vaccine, walking to car when client started to feel "...
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Client was in observation for 15 minutes after vaccine, walking to car when client started to feel "throat tightness and difficulty swallowing" and returned to observation area with husband. Client also reported chest pressure while walking to observation area. Client reports this also happened with first COVID vaccine 3 weeks ago. Vital signs stable, able to have conversation and answer questions. RN offered Benadryl, client declined. Chest pressure resolved, throat tightness stayed the same. Client left home with husband.
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| 52 | 2021-04-14 | nausea |
Patient received second dose of Pfizer COVID-19 vaccine. Patient stated she felt dizzy, heart was ra...
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Patient received second dose of Pfizer COVID-19 vaccine. Patient stated she felt dizzy, heart was racing, and feeling not well. Patient took Benadryl for the nausea and stated she felt slightly better. Patient was advised by doctor, if blood pressure increases to take Metoprolol which she took half a dose. EMT was called and patient blood pressure was elevated and they could not get blood pressure to drop. EMT advised patient to go to the emergency room and EMT escorted patient.
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| 52 | 2021-04-20 | abdominal discomfort, nausea |
COVID pneumonia; Hematological; bleeding; having hemoxysis; slight troponin increase; GI bleed; head...
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COVID pneumonia; Hematological; bleeding; having hemoxysis; slight troponin increase; GI bleed; headaches; COVID-19 test was positive; COVID-19 test was positive; nauseous; abdominal discomfort; body aches; This is a spontaneous report from a contactable physician. A 52-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age 52-year-old on 12Mar2021 at single dose for COVID-19 immunisation. Medical history included hemodialysis for many years, adherent to medical care, multiple DVTs and Pes (On anticoagulants), morbid obesity, Patient was on dialysis for renal failure and had lupus anticoagulant (positive), Afib, allergic to shellfish. Family history included renal failure and had lupus anticoagulant. Concomitant medications included warfarin sodium (COUMADIN); metoprolol; amitriptyline; calcitriol; ergocalciferol (VIT D); calcium; calcium acetate (PHOSLO); amiodarone; albuterol. The patient previously allergic to Cipro, clindamycin, doxycyclin, Lyrica, tetracycline. The patient previously was non-responder to hepatitis B vaccine. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 for COVID-19 immunisation. The patient hasn't been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient wasn't smoker/ former smoker. There was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. A nephrologist who reported patient in her hemodialysis unit who were vaccinated with BNT162b2 but were recently diagnosed with COVID-19. More detail is below on each patient. The patient COVID results were sent to the local health department for genetic sequencing (pending) and SARS titers were drawn (pending). Unfortunately, the HD unit does not have B/L information (although the B/L # was put on the patient's COVID vaccine cards, a record was not kept in the HD unit). Day she came in for dialysis she was already short of breath she said she'd had body aches for 5 days, got short of breath on 05Apr2021. The day before, started getting cough, nauseous, chills, abdominal discomfort on 04Apr2021. The patient was sent to the ER from dialysis and was admitted for SOB on 05Apr2021 and passed away on 09Apr2021 due to a GI bleed. Patient is over 500lbs so was unable to fit into hospital imaging equiment for CT scans or weight measurements. COVID-19 test was positive on 05Apr2021; the patient experienced COVID pneumonia on 05Apr2021. The patient admitted on 05Apr2021 to regular floor. The patient was moved to an Intensive Care Unit on 06Apr2021. The patient experienced short of breath on 05Apr2021 and required much more O2 than normal. Sometimes required BP support while on Dialysis and BP was 113/61 in ER. Pressure dropped to 100/70 and required mitrodrine after fluid was removed. The patient needed 4 liters supplemental O2 vs. only needing 2 liters at home. The patient experienced tachypnea and hypoxemia and no Respiratory failure. Respiration was 22. After 5 litres of O2 improved. Pulse 93 in ER. Cardiovascular: There was no heart failure, cardiogenic shock, Acute myocardial infarction, arrhythmia and myocarditis. The patient Had chest pain which resolved when O2 was administered. Gastrointestinal/Hepatic: There was no Vomiting, Diarrhea. The patient experienced nausea but no vomiting or diarrhea and complained of abdominal pain. There was no Jaundice and acute liver failure. Neurological: There was no altered consciousness, altered consciousness, encephalopathy, meningitis and cerebrovascular accident. The patient had headaches a couple days before admitting to ER. Hematological: There was no Thrombocytopenia, Disseminated intravascular coagulation. INR was 3 due to large dose of coumadin, and platelets were 180 and white count 6.8. Slight troponin increased at 0.37 at admittance, BNP 39. The patient started coughing up blood, having hemoxysis and bleeding on unspecified date. Laboratory test or diagnostic studies was reported that test for SARS-CoV-2 by PCR, or other commercial or public health assay. Xray showed vascular congestion with superimposed infiltrate which could represent pneumonia. Blood count was 11 and 36.7% at ER. Clinical chemistry: Sodium was 133; BUN was 68; Creatinine was 10. Evidence of hypoxemia: Pulse oO2 was 90 in ER. CT scans: unknown results. Urinalysis: On dialysis so does not make urine. The patient had received Remdesivir, from 06Apr2021, Hydroxychloroquine/chloroquine, Azithromycin from 06Apr2021 and Corticosteroids from 06Apr2021 for COVID-19. The outcome of event "GI bleed" was fatal, the event "chest pain" and "body aches" was recovered and other events was unknown. The patient died on 09Apr2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of the suspect drug cannot be excluded for the events vaccination failure, COVID-19, COVID-19 pneumonia, and sepsis. However, the patient's multiple medical comborbidities including renal failure requiring dialysis, lupus, and morbid obesity along with the risk of COVID-19 infection in light of the current pandemic are the more likely explanations for the development of these infections. The events gastrointestinal hemorrhage, hemorrhage, hemolysis and troponin increased are attributed to intercurrent medical conditions, and are considered unrelated to the suspect drug. The patient is currently on warfarin which may increase the risk for bleeds. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: GI bleed
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| 53 | 2021-01-03 | nausea |
Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness,...
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Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness, felt presyncopal,, facial flushing, throat pressure, had elevated BP, itchy cheeks, nausea, chest pressure. Went to ER where they treated her like she had an anxiety attack. No epi given. Patient consulted with her own private ENT?allergist Dr. the next day who states it sounded like a reaction and prescribed Xyzal
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| 53 | 2021-01-03 | nausea |
I developed a raised rash on my left arm at injection site , had chills and nausea and lots of tende...
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I developed a raised rash on my left arm at injection site , had chills and nausea and lots of tenderness at injection site at 3 am (1/1/21) following injection. The nausea had resolved when I woke up, the rash subsided throughout the day as did the chills. The most distressing event began on 1/1/2021 , that being sneezing, runny nose and watery eyes which continued and got much worse over the next two days, despite taking sudafed as often as possible. No other cold or flu symptoms were present and it felt like allergies although I have never had any sort of seasonal allergies. I finally took Zyrtec for it the evening of 1/3/21 and the symptoms stopped. Congestion, light sensitivity remain. I am reluctant to take another dose due to drowsiness side effect. Hoping symptoms will all be gone by tomorrow.
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| 53 | 2021-01-04 | nausea | Headache, nausea, light-headed. Mostly resolved after 30 minutes of observation. |
| 53 | 2021-01-04 | nausea, vomiting |
Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her l...
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Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her left trapezius, and headache. She experienced a warm sensation travelling down her left arm. She described a feeling of muscle spasms in her left upper and lower extremity and was unable to bear weight on her left lower extremity due to the altered sensation. She endorsed acute nausea and vomiting. She was transferred from vaccine clinic to emergency department at 1420. Patient received diphenydramine 12.5mg IV @ 1722, prochlorperazine 10mg IV @1733, Lactated Ringers 250mL IV bolus @ 1733, ondansetron ODT 4mg @1445. Patient was diagnosed with an acute anxiety attack in the setting of a novel vaccine administration. She was discharged at 1854.
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| 53 | 2021-01-04 | nausea |
Shortness of breath; heaviness in chest; headache; dizziness; nausea; The patient also received firs...
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Shortness of breath; heaviness in chest; headache; dizziness; nausea; The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 53-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 29Dec2020 11:30 at single dose for COVID-19 immunization at a hospital. The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine (29Dec2020) at left arm. The patient's medical history included diabetes type 2, arthritis, known allergies to Shrimp and penicillin. The patient's concomitant medications received within 2 weeks of vaccination included unspecified medications. No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took lisinopril and experienced drug hypersensitivity (Known allergies: Lisinopril). The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 post the vaccination. On 29Dec2020 11:30, the patient experienced shortness of breath, heaviness in chest, headache, dizziness and nausea. Treatment for above events included antihistamine. The outcome of the events shortness of breath, heaviness in chest, headache, dizziness and nausea was recovered in Dec2020. The events were reported as non-serious by the reporter. Information on the lot/batch number has been requested.
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| 53 | 2021-01-04 | vomiting, nausea |
This RN received the COVID 19 vaccine 12-17-2020 at 1730 . Called manager at 1040 to report nausea, ...
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This RN received the COVID 19 vaccine 12-17-2020 at 1730 . Called manager at 1040 to report nausea, vomiting and terrible headache. No fever noted.
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| 53 | 2021-01-04 | diarrhea |
fever; Diarrhea; headache; chills; feeling unwell; Joint pain; injection site pain; tiredness; This ...
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fever; Diarrhea; headache; chills; feeling unwell; Joint pain; injection site pain; tiredness; This is a spontaneous report from a contactable consumer. A 53-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EK5730), intramuscular (Dose number 1, Arm left) on 23Dec2020, 13:45 at single dose for COVID-19 immunization. Medical history included diabetic, thyroidectomy, hysterectomy, tonsillectomy, and Known allergies: Sulfa. Concomitant medication included zolpidem, levothyroxine, and pantoprazole from unspecified dates for an unspecified indication. The patient experienced fever, diarrhea, headache, chills, feeling unwell, joint pain, injection site pain, and tiredness on 23Dec2020 13:45. No treatment for AE was given. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was not recovered. Events were reported as non-serious.
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| 53 | 2021-01-04 | nausea | headache, low grade fever, body aches, nausea |
| 53 | 2021-01-05 | nausea |
Dizziness Lightheadedness Nausea Monitored for 30 minutes total; no intervention required and releas...
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Dizziness Lightheadedness Nausea Monitored for 30 minutes total; no intervention required and released to home.
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| 53 | 2021-01-05 | nausea |
I started having nausea, headache and nasal congestion at 2:54 pm on 12/19/2020. This lasted until ...
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I started having nausea, headache and nasal congestion at 2:54 pm on 12/19/2020. This lasted until 12/21/2020 at 9:23 pm. I had tried Sprix, Zomig 5mg and Promethazine 12.5mg. The nausea went away, but the headache persisted. I had originally thought it was a migraine and treated it as such, but my rescue medications did not work, so I thought it could be a side effect of the vaccination.
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| 53 | 2021-01-05 | nausea, retching |
PATIENT C/O DIZZINESS, HEADACHE, NAUSEA WITH DRY HEAVING, BP 184/90 AT 7:40AM. EPI 0.3MG ADMINISTER...
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PATIENT C/O DIZZINESS, HEADACHE, NAUSEA WITH DRY HEAVING, BP 184/90 AT 7:40AM. EPI 0.3MG ADMINISTERED AT 7:50AM. SYMPTOMS IMPROVED, BP 179/79 HR 114 AT 7:53AM. PATIENT REFUSED AMBULANCE OR FURTHER MEDICAL TX. STAFF MEMBER OBSERVED FOR AN HOUR UNTIL FAMILY ARRIVED.
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| 53 | 2021-01-05 | decreased appetite |
Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and w...
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Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported a 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown, did not see this information on the vaccination card), via an unspecified route of administration in the left arm on 20Dec2020 at single dose for covid-19 immunization (certified nurse assistant in healthcare). Other products, patient history and investigation assessment was No. There were no concomitant medications. The patient was vaccinated with the COVID Vaccine on 20Dec2020 but tested positive afterwards on 27Dec2020. The patent thought she had COVID in the vaccine and COVID in her body. She was scheduled for next dose on 10Jan2021 and would like to know if she should get the scheduled dose or if she needs to wait longer and re-schedule it. She was now a COVID patient and sick. She was waiting to get better. Before the vaccine she tested negative and felt great. Then she got the vaccine. She had a runny nose and felt achy. She asked her coworker, and her coworker felt the same. She thought if it continued that maybe it was a side effect. Caller confirmed her symptoms were runny nose, feeling achy, and coughing. She took Tylenol and the aches went away. They then came back, and she had more aching and she was wondering why. Caller clarified that these symptoms did not start the next day after receiving the vaccine. Achiness/body aches was started on 23Dec2020 when she was at work. It would wake her up at night. She did have aches right now, but her fever had lowered down. She was also dizzy and weak. It was affecting her legs and she had no taste. She was not eating but needs to eat. If she did, she eat something sweet. Runny nose was started on 24Dec2020. She went back to work on 26Dec2020 but told them she could not work because she had symptoms of COVID. She went to her second job where they do COVID testing and asked her boss for a test. She tested positive on 27Dec2020. Dose was unknown. She said she thought she got 1 vial. The whole thing. The outcome of events "tested positive for COVID after receiving the vaccine" was not recovered. Information on lot/batch number has been requested.
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| 53 | 2021-01-06 | nausea |
Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative: Medication and se...
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Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative: Medication and self-care instructions: drink plenty of fluids, take motrin if needed.please return if symptoms worsen or persist.
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| 53 | 2021-01-06 | nausea |
Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injectio...
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Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injection site swelling, injection site redness, nausea, swollen lymph nodes, sneezing, runny nose, dizziness and weakness, and slight chest pressure. Symptoms came and went but the palm sized redness and swelling at the injection site with extreme itching continues to this day. Used cold compresses, topical lotion for allergies, and Vaseline but nothing helped. Will try Benadryl.
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| 53 | 2021-01-07 | diarrhea |
Diarrehia; This is a spontaneous report from a contactable other healthcare professional (patient he...
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Diarrehia; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 53-year-old female patient (no pregnancy) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), with first dose (lot number: EJ1685) at 10:00 on 18Dec2020, with second dose (lot number: EJ1686) on 05Jan2021, both via an unspecified route of administration at site of right arm at single dose for COVID-19 immunization. Medical history included hypertension, cholesterol and known allergies: latex, pencillin and ACE inhibitors. Concomitant medication included hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ) and simvastatin, both received within 2 weeks of vaccination. The patient experienced diarrehia at 14:30 on 05Jan2021. Facility where the most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment was not received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date. The case was identified as non-serious by reporter. The outcome of event was recovering.
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| 53 | 2021-01-07 | difficulty swallowing |
Entered post-monitoring area at 1750, notified RN of prior itching and hives post first dose COVID-1...
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Entered post-monitoring area at 1750, notified RN of prior itching and hives post first dose COVID-19 vaccination. Reported that she had taken Benadryl 50mg PO after first vaccination. Pt reported today 1/7/20, she took medication prior to COVID-19 vaccination: Pepcid 40mg PO at 1626. Benadryl 25mg PO at 1626. 1810: pt c/o scalp itching, visible redness to itchy area on scalp. BP 158/84 (101), HR 82, regular rhythm, SpO2 97%, RR 18, Temp=97.5F 1812: 25mg Diphenhydramine HCL oral solution given PO for itching to scalp. 1818: BP 159/93 (108), HR 78, regular rhythm, SpO2 98%, RR 17, Temp =98 F 1822: Splotchy redness noted to pt's L lower arm, no itching. Redness noted to L upper chest with pt c/o itching to L upper chest area, R neck, nose and R toes itching. Pt denies difficulty breathing, swallowing. SpO2=98% 1830: BP 172/84 (105), HR 82, regular rhythm, SpO2 100%, RR 16, Temp=97.5 F Pt denies any new areas of itching, scalp, R toes, R neck and R chest area still itchy. No c/o difficulty swallowing or breathing. No throat clearing. 1837: pt notes improvement in scalp and nose itching. Redness to L arm and chest improved. 1845: BP 165/80 (102), HR 85, regular rhythm, RR 16, SpO2=99%, Temp =98.2 F Pt c/o itching again to R side of scalp with redness noted to scalp. 1850: 25mg Diphenhydramine HCL oral solution given PO for itching and redness to scalp. 1900: BP 153/87 (104), HR 85, regular rhythm, RR 12, SpO2=98%, Temp=97.6 F Pt reports mild scalp itching with some improvement since second dose of diphenhydramine. No other itching or redness noted. 1915: BP 171/86 (107), HR=80, regular rhythm, RR 12, SpO2=99%, Temp=97.4 F pt reports mild itching to L scalp and L chest, no significant redness noted. 1930: Pt denies worsening symptoms, no additional itching or redness. Gave pt discharge instructions to not exceed 100mg of Diphenhydramine in a 4 hour period. Recorded times and amounts of diphenhydramine given during post vaccine monitoring period. Pt denies feeling drowsy and is comfortable driving home. Directed patient to call emergency services from home with any worsening of rash or trouble breathing, feeling faint, or any other concerning symptoms. Pt's husband will be at home with pt, aware of additional monitoring needed post vaccine.
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| 53 | 2021-01-07 | nausea | chills, nausea, arm sore |
| 53 | 2021-01-08 | diarrhea | Diarrhea Fatigue for 24 hours post vaccination. Loose stools were for 3 days |
| 53 | 2021-01-10 | nausea |
Woke at 3 am with severe myalgias, tachycardia, nausea and shortness of breath. Went to get tyleno...
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Woke at 3 am with severe myalgias, tachycardia, nausea and shortness of breath. Went to get tylenol/ zofran but felt like I was going to vomit. Went into the bathroom and sat down. Woke up on the floor shaking. Not sure how long I was down. According to my watch my HR was around 110+ for a hour and a half (3-4:30 am)
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| 53 | 2021-01-11 | nausea |
4/5 hours bad headache, flu symptoms , nausea, Later that night I had chills, fever and was flush...
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4/5 hours bad headache, flu symptoms , nausea, Later that night I had chills, fever and was flushed which all lasted two days
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| 53 | 2021-01-11 | nausea |
Nausea, lightheaded, dizziness and headache starting 10 mins after. Felt like she was going to faint...
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Nausea, lightheaded, dizziness and headache starting 10 mins after. Felt like she was going to faint. Also felt like she was developing a migraine. Improved after about 20 minutes.
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| 53 | 2021-01-11 | nausea, diarrhea |
Rapid onset (less than 5 minutes) of acute migraine (knife-like stabbing pain in both temples, photo...
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Rapid onset (less than 5 minutes) of acute migraine (knife-like stabbing pain in both temples, photophobic), nausea & diarrhea. This occured 4 days after my second COVID-19 vaccine. I had no symptoms prior to this.
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| 53 | 2021-01-11 | nausea |
nausea; Headache; insomnia; This is a spontaneous report from a contactable healthcare professional....
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nausea; Headache; insomnia; This is a spontaneous report from a contactable healthcare professional. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 30Dec2020 14:00 at a single dose for COVID-19 immunisation. Medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. There were no allergies to medications, food, or other products. Concomitant medications included vitamin b complex (VITAMIN B), colecalciferol (VITAMIN D [COLECALCIFEROL]), and zinc. On 31Dec2020, the patient experienced nausea, headache and insomnia. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovering Information about batch/lot number has been requested.
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| 53 | 2021-01-12 | nausea, abdominal pain |
After patient received Covid 19 second dose experienced fever for 4 days, severe joint pain, nausea,...
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After patient received Covid 19 second dose experienced fever for 4 days, severe joint pain, nausea, significant abdominal pain and abdominal cramping with nausea for 3 days, headache, body aches, fatigue. Unable to work . Injection site pain was minimal lasting 1 day.
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| 53 | 2021-01-12 | nausea |
Experienced intense nausea and dizziness within 25 minutes of injection; tachycardia, increased bloo...
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Experienced intense nausea and dizziness within 25 minutes of injection; tachycardia, increased blood pressure; skin redness with blotches on face and neck; uncontrollable shaking; chills. These diminished to tolerable level within 30 minutes after onset. Evening of injection: nausea, vomiting, fatigue, muscle cramping. Next day: nausea, light headedness
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| 53 | 2021-01-12 | vomiting, nausea | Fatigue, chills, nausea, throwing up, body aches - persisted 2 days after 2nd dose shot |
| 53 | 2021-01-12 | nausea |
Two hours after second dose, 1/12/2021, nausea, mild headache. In evening fatigue, aching all over. ...
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Two hours after second dose, 1/12/2021, nausea, mild headache. In evening fatigue, aching all over. Next day 1/13/2021, flu like symtoms, felt feverish, sluggish, ache all over, felt better after 3PM in afternoon, but not 100% normal.
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| 53 | 2021-01-13 | nausea |
15 hours after the vaccine was received I started to experience a migraine-like headache, nausea and...
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15 hours after the vaccine was received I started to experience a migraine-like headache, nausea and muscle aches.
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| 53 | 2021-01-13 | diarrhea |
FIRST DOSE- FEELING HOT, CHILLS, TIREDNESS, MILD HEADACHE AND GENERAL BODY PAIN SECOND DOSE-FEVER, ...
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FIRST DOSE- FEELING HOT, CHILLS, TIREDNESS, MILD HEADACHE AND GENERAL BODY PAIN SECOND DOSE-FEVER, CHILLS, SEVERE HEADACHE, ITCHY IN THE VACCINATION AREA AND PAIN IN THE VACCINE ARM AND RADIATES UNDER THE ARMPIT TO THE BREAST AND DIARRHEA
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| 53 | 2021-01-13 | nausea |
Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lig...
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Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lightheaded 1st, then headache, feels like someone is pressing down on head and neck- temples and note- feels like a band around head. Pain is 2/10, progessed to 6/10. States muscles are starting to get sore around trapezius region. Stated she had feeling of euphoria initially, BP 128/76, HR 66, 98% RA. Nausea, but no emesis. Metallic taste to mouth- pins and needles when drinking water.
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| 53 | 2021-01-13 | nausea |
Severe myalgia; arthralgia; body stiffness; pain/pain under right axilla, extending to right chest a...
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Severe myalgia; arthralgia; body stiffness; pain/pain under right axilla, extending to right chest and neck; fatigue; Nausea; food aversion; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; first dose on 18Dec2020 15:30, second dose on 06Jan2021 12:15; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration on 06Jan2021 12:15 in right arm at single dose for COVID-19 immunization. Medical history included ADHD (attention deficit hyperactivity disorder), depression in remission, Known allergies: yes: Nitrofurantoin, cephalexin, penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medication included ashwagandha (ASHWAGANDHA), rhodiola rosea (RHODIOLA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 15:30 for COVID-19 immunization. Adverse event on 07Jan2021 01:00: Severe myalgia, arthralgia, body stiffness, pain and fatigue in early AM of 07Jan2021, continuing into 08Jan2021, though improving. Nausea and food aversion on 07Jan2021, Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck still evolving as of this report. Treatment: Ibuprofen OTC, bed rest, warm showers, rest. The outcome of the events was recovering.
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| 53 | 2021-01-13 | vomiting, nausea | Systemic: Nausea, Systemic: Vomiting, Systemic: shortness of breath |
| 53 | 2021-01-13 | vomiting | Systemic: Vomiting |
| 53 | 2021-01-13 | diarrhea, abdominal pain upper, nausea |
Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm ch...
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Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm chills, temp 97.8 7:00pm warm shower 7:15pm diarrhea, shortness of breath, sweat dripping down body, dizzy, nauseated 7:45pm cool compresses on head and neck, clams, shortness of breath, still dizzy, weakened began shacking. 7:55pm. Dressed by husband and put in bed. Temperature 90.0 8:00pm 3 blankets on me, gloves on, socks and slippers on and heating pads to ankles and feet, still dizzy and shacking. no circulation to hand or feet. no capillary refill. 8:30pm Called nurse on Call who stayed on the phone with me for 45 minutes, two Advil taken. Trying to eat crackers and hydrate. 8:45pm. feeling blood flowing to hands but not feet. 9:45pm gloves off hands and heavy blanket off, toes still ice cold.10:15pm Up to bathroom with husbands help, no strength. Urinated, no more diarrhea. Stomach still making a lot of noise. Still sensitive to light and sound, feeling to toes, still dizzy.11:30pm Feeling more like myself. Just exhausted. Slept off and on throughout the night and hydrated and up to urinate on my own without assistance. Jan. 14, 2021 , 10:00am- Sitting up in bed. Very tired. Drinking water. 12:00 noon able to eat an egg and avocado sandwich
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| 53 | 2021-01-13 | nausea | dizzy, nauseous, tired that lasted 24 hours- missed a day of work |
| 53 | 2021-01-13 | abdominal discomfort | stomach issues, migraines. body aches Fatigue |
| 53 | 2021-01-14 | vomiting, nausea, diarrhea |
3:00 PM injection site pain swelling resolved within 48 hours 7:00 PM Skin redness sensitivity on ch...
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3:00 PM injection site pain swelling resolved within 48 hours 7:00 PM Skin redness sensitivity on chest, abdomen right trunk resolved within 6 hrs. 9:00 PM chills, body aches, nausea resolved within 48 hrs 1:50 AM. Diarrhea resolved within 12 hours 2:00 AM. Vomiting multiple times resolved within 30 minutes
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| 53 | 2021-01-14 | nausea |
COVID Vaccine Clinic. Upon staff member receiving vaccination, collapsed after getting up from chai...
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COVID Vaccine Clinic. Upon staff member receiving vaccination, collapsed after getting up from chair. Rapid Response was called. Staff member was positioned supine with legs elevated. Blood pressure 147/88 HR 92.Po2 at 100% on room air. Complained of feeling faint and dizzy. Assessed by Rapid Response RM and MD. Escorted via cart to mid hallway for further evaluation. SM symptoms continued to be concerning, transported to ED with MD escort. Staff member was evaluated in ED. fluids given, Zofran for nausea and Benadryl. CTOH was completed and resulted as no abnormalities. Staff member was discharged to home in stable condition.
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| 53 | 2021-01-14 | vomiting, nausea | Joint pain . Inflammation in knee Headache nausea vomiting |
| 53 | 2021-01-14 | nausea |
Light headache ( first day); nausea ( 3 days); severe fatigue (2 days); This is a spontaneous report...
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Light headache ( first day); nausea ( 3 days); severe fatigue (2 days); This is a spontaneous report from a contactable healthcare professional (patient). A 53-years-old female patient received first dose on bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number Bj1685, expiration date not reported), intramuscular, on the left arm, on 07Jan2021 at 15:00 at a single dose for Covid-19 immunization. Medical history included scleroderma, interstitial lung disease (ILD), and Raynauds. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant. On 06Jan2021, the patient had a nasal swab with negative result. On 07Jan2021, the patient experienced light headache (first day), nausea (3 days) and severe fatigue (2 days). The patient had a nasal swab with negative result on 06Jan2021. The patient did not receive treatment for the adverse events. The outcome of the events was recovering.
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| 53 | 2021-01-14 | nausea |
Nausea; fast heart rate; low grade temp (99.4-100); headache; body aches; soreness at site; This is ...
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Nausea; fast heart rate; low grade temp (99.4-100); headache; body aches; soreness at site; This is a spontaneous report from a contactable Nurse (patient herself). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 13:00 (Lot number: EK5730) at SINGLE DOSE (first dose, left arm); and via an unspecified route of administration on 07Jan2021 13:00 (Lot number: EK9231) at SINGLE DOSE (second dose, left arm) for COVID-19 immunization. Medical history included hypertension, high cholesterol, Graves disease, and Known allergies: Sulfa from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the vaccine at hospital. Concomitant medication included hydrochlorothiazide, atorvastatin, amlodipine from unspecified dates for unspecified indications. The patient experienced nausea, fast heart rate, low grade temp (99.4-100), headache, body aches, soreness at site on 08Jan2021 06:00. The patient underwent lab tests and procedures which included temp 99.4-100 and heart rate fast on 08Jan2021. Treatment was not received for adverse events. Event outcome was recovering. The reporter assessed the events as non-serious.
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| 53 | 2021-01-15 | decreased appetite |
Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very...
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Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very big, injection site is harder. Lower back at kidney sites are so painful. Weakness. No energy to lift up arms or legs. Have difficult to get up and get out of bed to get medicine or food. So sleepy, maybe because Tylenol 500mg q4h to help for pain but reduce just little from 10 down to 8 for a short time enough to get out of bed to get something. Ice pack at armpit, heat pat at lower back but just reduce the pain from 10 down to 9 only. No appetite. Eat lentil and rice porridge but indigestible and have to take Pepcid. All symptoms prolong until Friday 1/15/2021 around 1pm. I pushed myself hard to get up to drive to employee health for testing which I missed on Thursday due to unable to get up. After that the symptoms down to moderate that I able to report CDC. I wonder why 2 dose is so horrible to me.
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| 53 | 2021-01-16 | diarrhea | Chills, severe headache, muscle and joint pain, malaise, fever, diarrhea |
| 53 | 2021-01-16 | vomiting, nausea |
Hair and clothes wet with diaphoresis the night of injection, woke up with nausea, vomiting. Tempera...
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Hair and clothes wet with diaphoresis the night of injection, woke up with nausea, vomiting. Temperature ranged 99.5-101.3, l check my temp daily. Sweating, chills, headache, body aches and fatigue. The symptoms began to decline approximately 24H after vaccine but headache, mild nausea and extreme fatigue continued. I felt so bad that I missed 2 days of work and got a COVID test to be safe, as I am a nurse, results were negative and employer was made aware of reaction.
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| 53 | 2021-01-16 | nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA: dizziness, headache, muscle aches, nausea, chills, fever, tir...
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Pfizer-BioNTech COVID-19 Vaccine EUA: dizziness, headache, muscle aches, nausea, chills, fever, tiredness, feeling sick
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| 53 | 2021-01-16 | nausea, abdominal pain | Severe abdominal pain, nausea, high BP |
| 53 | 2021-01-18 | abdominal pain, diarrhea |
Developed shortness of breath, chills, diarrhea, abd pain, fatigue, chest pressure, body aches, sore...
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Developed shortness of breath, chills, diarrhea, abd pain, fatigue, chest pressure, body aches, sore throat on 1/13/2021. Continues to have sob, chest pressure, abd pain, and fatigue. COVID test neg on 1/17.
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| 53 | 2021-01-18 | nausea, retching |
I experienced chills, body aches, back pain, dizziness, nausea, dry heaves and passed out. When I pa...
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I experienced chills, body aches, back pain, dizziness, nausea, dry heaves and passed out. When I passed out, I bit my lower lip and it bled quite a bit. I had brain fog, and couldn't come up with the correct words. Also, I could not sleep that night, at all without taking a few sleeping pills. It has been a week since this happened and I still can't sleep on my own. I used to be able to go right to sleep without any sleeping pills within about 5 min after laying down at night.
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| 53 | 2021-01-18 | vomiting, abdominal pain |
Malaise, muscle ache, joint pain, abd pain, vomiting, swollen lymph node, headache, lightheadedness,...
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Malaise, muscle ache, joint pain, abd pain, vomiting, swollen lymph node, headache, lightheadedness, dizziness. Symptoms improved. Went to ER on 1/16/21, Covid test neg.
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| 53 | 2021-01-18 | difficulty swallowing |
Patient experienced arm pain, paresthesia, facial flushing, lightheadedness and sensation of dysph...
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Patient experienced arm pain, paresthesia, facial flushing, lightheadedness and sensation of dysphagia for several minutes after vaccine was received. Benadryl PO given when symptoms began. Patient was evaluated in the EC and was discharged home without symptoms.
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| 53 | 2021-01-18 | abdominal pain upper, nausea, diarrhea |
Right eye blood shot at 7:30 pm - went to ER with severe stomach cramps radiating the back. CT done...
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Right eye blood shot at 7:30 pm - went to ER with severe stomach cramps radiating the back. CT done. received dilaudid and Zofran for pain and nausea. Next day, had pain in bones, feet, knees, back and neck. Also sore throat, red throat, headache, nausea, and diarrhea. Doctor prescribe antibiotics and Norco. Stomach pain returned 12/31.
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| 53 | 2021-01-18 | nausea |
headache, body aches, fever, nausea, fatigue, injection site pain and redness, joint pain, not feeli...
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headache, body aches, fever, nausea, fatigue, injection site pain and redness, joint pain, not feeling well
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| 53 | 2021-01-18 | vomiting |
headache; fever 102.7; Chills; vomiting; arm pain; body aches; This is a spontaneous report from a c...
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headache; fever 102.7; Chills; vomiting; arm pain; body aches; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular on 18Dec2020 15:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma and diagnosed with COVID-19 prior to vaccination. Patient has unspecified allergies. Unspecified concomitant medication were taken (List of any other medications the patient received within 2 weeks of vaccination: Yes). The patient experienced fever 102.7, Chills, vomiting, arm pain body aches and headache on 19Dec2020 03:00. No treatment received for the events. The outcome of the events was recovered with sequelae (Recovered with lasting effects). The events were considered as non-serious. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular on 08Jan2021 at a single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date.
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| 53 | 2021-01-18 | difficulty swallowing |
right side of tongue from midline, swollen approx. 3X size of left side. some difficulty swallowing,...
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right side of tongue from midline, swollen approx. 3X size of left side. some difficulty swallowing, water. approx. 45-50 minutes after I woke with this, I noted a large sore area on the lateral left side of my tongue. Arrived at work 6:30am and noted I was speaking with a "lisp" and tongue was still the same, no changes noted. Very tired, no energy. Reported this to our employee health at 8:00 am when they opened. I then was offered a Claritin by a coworker. approximately 2 hours later the swelling and sore had completely subsided.
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| 53 | 2021-01-19 | nausea |
? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swellin...
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? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swelling of your face and throat ? A fast heartbeat ? A bad rash all over your body ? Dizziness and weakness
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| 53 | 2021-01-19 | abdominal pain upper, nausea | EPIGASTRIC AREA PAIN NAUSEA CHILLS |
| 53 | 2021-01-19 | vomiting, nausea | ON 1/20/21 DEVELOPED EYE/MOUTH DROOPING, VOMITING, NAUEA, CHILLS AND BODY ACHES. HAS CALL OUT TO PCP |
| 53 | 2021-01-19 | diarrhea | Shakes, fever of 102.8, sever body aches, diarrhea, headache, dizziness Lasted 24 hours. |
| 53 | 2021-01-21 | vomiting |
1/11 woke at 0400 with extreme shivering, vomiting, fever 101.8, headache. Previously COVID + 11/17/...
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1/11 woke at 0400 with extreme shivering, vomiting, fever 101.8, headache. Previously COVID + 11/17/2020.
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| 53 | 2021-01-21 | vomiting |
30 minutes of vaccine vomiting and blood pressure was high 190/106 then ER and blood pressure every...
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30 minutes of vaccine vomiting and blood pressure was high 190/106 then ER and blood pressure every 15 minutes for hour an normal . Prescription Anti Nausea Ondansetron 4 mg
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| 53 | 2021-01-21 | vomiting, nausea |
About the 35 minutes later became nausea and threw up, faint and blood pressure 190/106 she was sen...
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About the 35 minutes later became nausea and threw up, faint and blood pressure 190/106 she was sent to ER at time of admission blood pressure was going down and back to normal within hour and gave anti- nausea medicine . Blood pressure every :15 for hour 128/76 event resolve . Ondansetron 4 mg Face and chest rash 24 hours later Benadryl 25 mg
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| 53 | 2021-01-21 | abdominal pain |
First dose was given 12/23- Xuan states from 12/24-12/26 she had no energy, throat felt weird, chill...
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First dose was given 12/23- Xuan states from 12/24-12/26 she had no energy, throat felt weird, chills, and her arm was very sore for a day. Second dose was given 1/15- On 1/19 she had body aches, chills, severe headache, fatigue, abdominal pain, stuffy nose and sore throat. Her arm was very sore for several days, she could not raise her arm. Treatment: took tylenol every 6 hours for 24 hours. on 1/19 and 1/20 she took Dayquil.
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| 53 | 2021-01-21 | abdominal pain, nausea, diarrhea |
Headache that last two days. Severe chills that started day three and have continued for nine days....
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Headache that last two days. Severe chills that started day three and have continued for nine days. Nausea, diarrhea, abdominal pain, body aches, increased joint pain, increased inflammation, and increased fatigue that started day two and has continued for nine days.
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| 53 | 2021-01-21 | nausea, diarrhea, vomiting |
On 1/6 developed tenderness at left axilla and headache. That night began having muscle stiffening e...
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On 1/6 developed tenderness at left axilla and headache. That night began having muscle stiffening especially in back of neck, worsening headache. 1/7 awoke with nausea/vomiting lasting throughout the day and diarrhea also started. 1/8 continued vomiting but diarrhea stopped and also noted confusion and brain fog. 1/11 mostly recovered and back to work with slight headache and body soreness from exhaustion.
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| 53 | 2021-01-21 | vomiting, nausea, diarrhea |
Started with shaking chills at 11:45 pm 1/10/21 and fever spikes up to 103 degrees with body aches, ...
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Started with shaking chills at 11:45 pm 1/10/21 and fever spikes up to 103 degrees with body aches, nausea, vomiting and diarrhea, continuous headache for 4 days. Then started with productive cough and dyspnea on exertion. Took Tylenol initially and then Proair inhaler starting 1/15
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| 53 | 2021-01-21 | indigestion |
shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grad...
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shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grade fever and chills, digestive issues weight loss body aches.
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| 53 | 2021-01-22 | vomiting, nausea | Nausea; vomiting; headache; fatigue |
| 53 | 2021-01-23 | abdominal pain |
I woke up at around 0430 the morning following vaccination with dose two feeling feverish (alternati...
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I woke up at around 0430 the morning following vaccination with dose two feeling feverish (alternating chills and sweating - did not take temp), global muscle and joint aches and pains, abdominal pain, a feeling of exhaustion, pounding headache, and ringing in my ears. While most symptoms resolved with a dose of acetaminophen followed a few hours later with a dose of ibuprofen by 1600 the same day, the tiredness and abdominal pain lingered for four days, and the ringing in the ears is remaining persistent. The ringing has not yet ceased (today is day five post vaccination).
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| 53 | 2021-01-23 | nausea, retching |
No temperature prior to Vaccine. Track daily - run 97.4-97.7F normally Friday 1/22/2021: 1930 starte...
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No temperature prior to Vaccine. Track daily - run 97.4-97.7F normally Friday 1/22/2021: 1930 started feeling very tired 2030-2230: started to feel cold, skin sensitivity, developed into shaking chills, entire body shaking. Headache. Temperature rising 99F -- 100.4F --- 101.5F about every 1/2hr or so. 2100 Took Advil 600mg Midnight: Chills, HOT, Temp 102.4F. Dozing off and on through the night. Shaking and Hot. Headache. Feeling Nausea 0400: Temp 101.6F, tried to take Ibuprofen but dry heaved them back up. Sips of water. Took warm shower. 0500: back to bed, slept 1 hour 0600: saltines, gingerale - took Advil 600mg - laid back down. Head throbbing. Less Nausea. 0830: woke: Temp 100.4F Headache and hot, feel achy all over never leaves, feel woozy. Spent most of Saturday 1/23/2021 (My 54 Birthday) Laying and sleeping. Started taking Tylenol 1000mg (1/23 at 6pm) alternating with Ibuprofen 600mg every 6 hours exactly. Woke Sunday Morning - feeling less achy, but still with Temp 100.4-99.6F -- As Sunday went on - by afternoon/evening achy, skin sensitive, and Temp 100.4F, HEADACHING! Neck aching. Took Ibuprofen 600mg. Drinking gingerale and water through the day. Toast. Now almost Midnight 1/24/2021 Headache and feeling achy. (Right ARM only slight hurt this time. 1st Pfizer - hurt 8/10 day 2 &3)
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| 53 | 2021-01-23 | nausea |
Strong metallic taste in mouth within 2 minutes and lasted about 3 hours, intense left wrist started...
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Strong metallic taste in mouth within 2 minutes and lasted about 3 hours, intense left wrist started a prickly tingle about 5 minutes and lasted about 3 hours, mild left palm and arm started a prickly tingle about 10 minutes after injection and lasted 1 hour, started feeling light headed about 10 minutes after and lasted about 1 hour with no blacking out, warm flush feeling started about 5 minutes after the injection and lasted for 32 hours (did not take temperature), my chest felt very heavy and breathing was a little diminished which lasted about 20 minutes. The following morning I felt some nausea with mild dizziness that lasted about 4 hours.
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| 53 | 2021-01-24 | nausea |
20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a...
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20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a rash across my chest, headache, nausea, numbness/tingling in both hands and lightheaded.
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| 53 | 2021-01-24 | vomiting, diarrhea | Severe diarrhea, severe vomiting , severe headaches and chills |
| 53 | 2021-01-24 | nausea |
became dizzy, clammy diaphoretic and nauseated at the end of her 15 minutes. This was her second do...
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became dizzy, clammy diaphoretic and nauseated at the end of her 15 minutes. This was her second dose and had no problems with the first COVID vaccine dose. Continued nausea with lightheadness and started to see visual spots when lifting head. Benadryl 25 mg 1 tab given by mouth at 1258 pm. At 1345 pm attempted to have her stand at stretcher and she continued seeing spots, dizzy. At 1406 transported to the ED for evaluation. She was seen, evaluated and released to home from the ED.
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| 53 | 2021-01-25 | abdominal pain upper | Fever, chills, aches, general malaise, stomach ache |
| 53 | 2021-01-26 | vomiting, nausea |
I was flushed, my arm hurt, palpitations, dizziness, foggy brain, fast heart rate, fever, vomitting,...
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I was flushed, my arm hurt, palpitations, dizziness, foggy brain, fast heart rate, fever, vomitting, nausea, headache, stuffiness, congestion, swelling on the arm at the injection site, pain and rash around the injection site.
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| 53 | 2021-01-26 | vomiting, nausea |
dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side ...
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dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side numbness on my face limping leaning to the left side when walking tingling on my gums and teeth
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| 53 | 2021-01-26 | nausea |
elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbn...
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elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbness and tingling in both hands; nausea; rash across the top of my chest; sore muscles in legs; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 12Jan2021 10:30 at SINGLE DOSE for covid-19 immunization. Medical history included asthma, sinusitis and migraine. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol, estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE), vitamin d3, zinc, paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took erythromycin, levaquin, biaxin and cefzil (on unspecified dates) and experienced allergy. The patient started having reactions after 20 mins (12Jan2021, 10:45am): a bad headache, elevated BP: 193/113 (no history of hypertension), tachycardia 134 BPM, numbness and tingling in both hands, nausea, and a rash across the top of the chest. Since it was administered in a workplace drive-thru clinic, there was a 15-30 mins post vaccine monitoring. She was taken inside for further evaluation and monitoring with no changes after 30 mins. EMS was called for transport to the closet hospital that wasn't on diversion. Her allergist was consulted by the treating ER physician and was later discharged with prescriptions for the following: Epipen, prednisone for 5 days, and pepcid. Follow-up with allergist in 3-5 days and PCP. Patient was still recovering however headache was and sore muscles in legs were still present. The outcome of events headache was and sore muscles in legs was not recovered whereas patient was recovering from all other events. Therapeutic measures taken as result of the events included Benadryl, Pepcid, Zofran, Tylenol, 1L Saline bolus, EKG, lab work, monitoring on a pulse ox, frequent BP. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-01-27 | vomiting |
Starting the day after the vaccine she began having vomiting, and feeling dizzy and light headed. Sh...
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Starting the day after the vaccine she began having vomiting, and feeling dizzy and light headed. She also had chills.
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| 53 | 2021-01-28 | diarrhea, vomiting, nausea |
Headache, Myalgia, Fever, Diarrhea & NauseaVomiting Narrative: Employee taking Tylenol for body ach...
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Headache, Myalgia, Fever, Diarrhea & NauseaVomiting Narrative: Employee taking Tylenol for body aches & Fever.
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| 53 | 2021-01-28 | nausea |
Nausea; Headache; This is a spontaneous report from a contactable consumer (patient). A 53-year-old ...
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Nausea; Headache; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3302, expiry date: unknown), via an unspecified route of administration in the left upper arm, on 12Jan2021 at a single dose for covid-19 immunization. Medical history was not reported. Concomitant medications included other medications but declined to provide those medications. The patient previously took azithromycin and amoxicillin, clavulanic acid (AUGMENTIN) and experienced allergies. The patient had no history of previous immunization and no additional vaccines administered on same date of the suspect drug. The patient had no prior vaccination within four weeks. On 13Jan2021, the patient experienced severe nausea and headache. The patient reported she just stayed at home and drinking ginger ale and crackers. The events did not require visit to emergency room or physician office. Therapeutic measures were taken as a result of the events nausea and headache. Outcome of the events nausea and headache was not recovered.
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| 53 | 2021-01-28 | nausea |
Patient began to feel cold with severe headache and experienced nausea 5 minutes after injection. Be...
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Patient began to feel cold with severe headache and experienced nausea 5 minutes after injection. Benadryl was given. Blood pressure was 144/88. Patient was observed for 1 hour. Following 1 hour, she went to her office and planned to go home. Patient was later called to identify if symptoms were still occurring, but did not answer. Voicemail was left.
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| 53 | 2021-01-28 | decreased appetite |
mild fever; chills; anorexia; headache; discomfort in her chest; myalgia/severe muscle pain; leg pai...
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mild fever; chills; anorexia; headache; discomfort in her chest; myalgia/severe muscle pain; leg pain; Looked pale; was so hungry; This is a spontaneous report from a contactable physician (patient herself). A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. The patient medical history included that the patient has a severe allergy cold and humidity and therefore before getting the vaccine she took an Advil and loratadine. There were no concomitant medications. The first dose of BNT162B2 for COVID-19 immunization was given on 23Dec2020 (Lot: EL0140) at the age of 53 years old and reported sore arm (added that she cannot move it from the pain) for 24 hours. In regards to the first dose, she only had a severe sore arm and couldn't elevate the arm but this only lasted for 24 hours and then she didn't have any soreness. She received the second dose on 13Jan2021 and experienced mild fever, chills, anorexia, headache, and myalgia. Her supervisor asked her to test positive for covid however she is wondering if she could get a false positive since it is still within 72 hours after vaccination. Patient asked if after vaccination do they not check for antibodies to make sure the vaccine is working. The patient reporting on COVID and who stated she got her second dose on Wednesday (13Jan2021) and who stated she has some questions about side effects and getting tested after vaccination. It was explained that she has had fevers, chills, headache, and discomfort in her chest (Jan2021). She was told to get a test by her job but wondered if she will test positive since it has been less than 72 hours since getting the vaccine. She got the second shot around 7:50pm or 8pm. At midnight she woke up with chills, mild fever, and severe muscle pain. Then she woke up in the morning early with a headache, severe muscle pain, it was very hard to make it. She had severe anorexia, she was so hungry she ate a little and went back to bed. Then she only woke up for lunch and ate something. At that time her fever was gone. She went back to bed but at 8pm she woke up and still had muscle pain. She had a very difficult time yesterday. In the night she woke up with leg pain, muscle pain. The patient explained she felt better today so she went to work and spoke to her supervisor who told her it was better to take a test for COVID. It was mentioned she looked pale and it was better for her to have a test just in case. The patient reported that she knows a bit about vaccines and the proteins and RNA. Since it has been less than 72 hours since she had the second dose, would she test positive if she had a COVID test. No treatment after the doses. Patient states she has no had any testing done at this point. Therapeutic measures were taken as a result of event so hungry. The event fever recovered on an unspecified date in Jan2021. The outcome of the events chills, anorexia, headache, discomfort in her chest and myalgia/muscle pain, leg pain, looked pale, and was so hungry was unknown.
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| 53 | 2021-01-31 | nausea |
could not get out of bed; whole body aches; shaking; significant nausea; significant dizziness; head...
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could not get out of bed; whole body aches; shaking; significant nausea; significant dizziness; headaches; immediate reaction up to jaw, ear and shoulder/ she felt it on the left side of her jaw and her left ear, and down her arm and it was tingling down her hands; not feeling well; very stressful; This is a spontaneous report from a contactable consumer for herself. A 53-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) intramuscularly at upper left arm, 12:45PM on 08Jan2021 to prevent Covid. The patient had no medical history. She did not get sick and had not taken a sick day in 5 years. Patient had not received other vaccines within four weeks. Patient had no concomitant medications. The patient had an immediate reaction up to jaw, ear and shoulder following first dose on 08Jan2021. When she got the injection, she could feel the stuff going in and something on the left side of her jaw, and she brought her right hand up to rub her jaw. She was not sure if a nerve may have been hit, but she felt it on the left side of her jaw and her left ear, and down her arm and it was tingling down her hands. This has recovered completely at the time of reporting. She had not been feeling well since that day and got worse. On Wednesday (13Jan2021), it started with significant dizziness and her headaches started toward the end of day. By Thursday (14Jan2021) she had the headache and significant nausea. The body aches started on Thursday. Her whole body ached so much that she was shaking. On Friday (15Jan2021) she could not get out of bed since the headache was intense along with the dizziness and nausea. She received Advil and Tylenol as treatment and was also taking clonazepam since it had been very stressful. She was worried since she felt safe going in to get the vaccine and she did not feel so safe now. At the time of reporting, she improved but not recovered. She would like to know what she is experiencing is a side effect or if she should be tested for Covid. The outcome of tingling feeling resolved, stressful was unknown and outcome of other events was resolving. Information on the lot/batch number has been requested.
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| 53 | 2021-01-31 | nausea |
not feeling good; feeling weak; Chills; hurt like someone hit her; feeling real thirsty; like she wa...
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not feeling good; feeling weak; Chills; hurt like someone hit her; feeling real thirsty; like she was going to pass out; Fever; Nausea; tingling on her face; This is a spontaneous report from a contactable consumer (patient). A 53 years old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date Apr2021) via Intramuscular on 14Jan2021 (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's ongoing medical history heart murmur and high blood pressure diagnosed about 10 years ago. The concomitant medications was reported as none. Patient was still not feeling good. She said that she had side effects that started on Saturday 16Jan2021. Caller clarified that she had fever, nausea, and tingling on her face. Fever was noticed it on Saturday 16Jan2021 and gone by about 2am on Sunday 17Jan2021. Patient stated that she was feeling real thirsty. Nausea was still there and this morning, patient felt like she was going to pass out. She stated that she had weakness. She stated that she is trying to make an appointment to see her doctor. She stated that the nausea is persisting, but the nausea comes and goes. She stated that yesterday she felt ok, but this morning, she felt nauseated and like she was going to pass out. Patient said that the tingling stopped around 17Jan2021 02:00 along with the fever. Patient stated that she is drinking Gatorade and eating crackers and is staying stay hydrated. She stated that she is at work, but she feels weak. She stated that she had chills and she hurt like someone had hit her. She noticed these symptoms on Saturday 16Jan2021 and stated that this was ongoing and they come and go. The outcome of fever and tingling on her face was recovered on 17Jan2021 02:00. The outcome of not feeling good and feeling real thirsty was unknown. The outcome of other events was not recovered.
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| 53 | 2021-02-03 | abdominal discomfort |
Piercing eye pain; Swollen/red left eye; Swollen/red left eye; Extreme photophobia; Body wide muscle...
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Piercing eye pain; Swollen/red left eye; Swollen/red left eye; Extreme photophobia; Body wide muscle pain; Fatigue; Increased dry mouth; GI upset; Nasal congestion; Wheezing; Shortness of breath; This is a spontaneous report from a contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9262,), via an unspecified route of administration in left arm on 21Jan2021 at 16:45 as a single dose, for COVID-19 vaccination. The most recent COVID-19 vaccine was administered at a Workplace clinic. Medical history included rheumatoid arthritis dry eye, hypertension, anxiety and asthma. Concomitant medication included lisinopril (LISINOPRIL), paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]), iron (IRON), oxymetazoline hydrochloride (CLARITIN ALLERGIC), montelukast sodium (SINGULAIR). No other vaccines were given within 4 weeks. . Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot Number:PFR-20364-01; in the right arm on 29Dec2020, at 09:00. On 22Jan2021 at 05:00, the patient woke the day after at 5AM with piercing eye pain along with swollen/red left eye. extreme photophobia. body wide muscle pain. fatigue. increased dry mouth. GI upset. nasal congestion. Wheezing. Shortness of breath. No treatment was received given for the events. The clinical outcome of piercing eye pain along with swollen/red left eye. extreme photophobia. body wide muscle pain. fatigue. increased dry mouth. GI upset. nasal congestion. Wheezing. Shortness of breath was recovering. Prior to vaccination, was the patient diagnosed with COVID-19?:No Since the vaccination, has the patient been tested for COVID-19?:No Allergies to medications, food, or other products:no Vaccine Facility information available. Ethnicity information is available. Race information is available.
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| 53 | 2021-02-03 | nausea |
fever 101; headache; chills; muscle pain; weakness; nausea; fatigue; This is a spontaneous report fr...
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fever 101; headache; chills; muscle pain; weakness; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on an unspecified date at 10:00 at single dose on left arm for COVID-19 immunisation. Medical history included depression/anxiety, back pain, COVID prior vaccination and known allergies: sulfa and penicillin. Concomitant medication included naproxen, sertraline HCL (ZOLOFT), fish oil, ospemifene (OSPHENA) and docusate sodium (COLACE), all from unknown date for unknown indication. On 12Jan2021 at 17:00, patient experienced fever 101, headache, chills, muscle pain, weakness, nausea and fatigue. Events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. Nasal Swab on 14Jan2021 was negative. Patient recovered in Jan2021. Information on the lot/batch number has been requested.
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| 53 | 2021-02-04 | nausea | I got severe vertigo. I was dizzy and had naseau. This was approximately 60 hours after the shot. |
| 53 | 2021-02-04 | nausea |
Nausea, headache, severe muscular and joint aches, night sweats, weird dreams, golf ball size red c...
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Nausea, headache, severe muscular and joint aches, night sweats, weird dreams, golf ball size red circle at injection site warm to touch, itchy with lump under skin.
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| 53 | 2021-02-04 | abdominal pain, vomiting, diarrhea |
She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrena...
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She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrenal glands are over compensating, working over load; she was having diarrhea; throwing up; she went from cold to profusely sweating back to having chills; she went from cold to profusely sweating back to having chills; she had no blood to her extremities; severe abdominal cramps; headache; her body is just weak; she was feeling dizzy; Her legs were cramping; her heart was racing fast; her lactic acid was really high; This is a spontaneous report from a contactable Nurse. A 53-years-old female patient receive the first dose of bnt162b2 (BNT162B2; Lot # EL3249) vaccine , via an unspecified route of administration in the right deltoid on 13Jan2021 15:55 at single dose for Covid-19 immunisation . Medical history included hypertonic bladder from an unknown date., drug hypersensitivity from an unknown date , migraine from an unknown date. She had migraines. Concomitant medication included solifenacin succinate (VESICARE), buspirone hydrochloride (BUSPAR), spironolactone (SPIRONOLACTONE). The patient previously took flu vaccine VII, bactrim and experienced drug hypersensitivity. The patient stated she thinks she had a delayed anaphylactic shock she was definitely in shock on an unknown date with outcome of unknown , hypothermic on an unspecified date with outcome of unknown , her adrenal glands are over compensating, working over load on an unspecified date with outcome of unknown , she was having diarrhea on an unspecified date with outcome of not recovered , throwing up on an unspecified date with outcome of unknown , she went from cold to profusely sweating back to having chills on an unspecified date with outcome of unknown , she had no blood to her extremities on an unspecified date with outcome of unknown , severe abdominal cramps on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of not recovered , her lactic acid was really high on 18Jan2021 with outcome of unknown , her body is just weak on an unspecified date with outcome of not recovered , her heart was racing fast on 18Jan2021 with outcome of unknown , she was feeling dizzy on 22Jan2021 with outcome of unknown , her legs were cramping on 19Jan2021 with outcome of unknown. The patient was hospitalized because of the events from 16Jan2021 to 17Jan2021. The patient underwent lab tests and procedures which included blood lactic acid: high on unknown date, chest x-ray: unknown results on unknown date, computerised tomogram: unknown results on 18Jan2021 , electrocardiogram: unknown results on unknown date. The patient was given fluids, Toradol and Xanax to treat the events. Further information has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 53 | 2021-02-05 | vomiting, diarrhea, abdominal pain, abdominal discomfort |
abdominal cramping x1day, vomiting, diarrhea x1day , upset stomach unable to eat x3days, weakness ...
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abdominal cramping x1day, vomiting, diarrhea x1day , upset stomach unable to eat x3days, weakness x2days, fatigue x4days, fever 102.6 x 1day, chills x1day.
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| 53 | 2021-02-08 | nausea |
her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that fel...
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her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that felt rapid; fatigue/tired; sluggish; nausea; she was not feeling well; Dry throat; injection site pain; This is a spontaneous report from a contactable consumer reporting for self. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1280) on 24Jan2021 at 0.3 ml single by injection to left upper arm for COVID-19 immunisation (reported as works in assisted living). Medical history and concomitant medications were not reported. The patient received the vaccine on 24Jan2021, Sunday morning, then 6 hours after started feeling injection site pain, it was really sore, but she packed it with ice that night and it was very slight now. She worked the following morning (25Jan2021), and was sluggish, fatigue, and tired. Also nausea (started in the afternoon), it was slight, she was not feeling well. She experienced fibrillation in her heart, and that felt rapid, that comes and goes. Also dry throat on 25Jan2021, not sore, just dry. Her voice was still a little raspy, not like it was yesterday, she had a hard time speaking, when talk and dry throat. The outcome of injection site pain was recovering, sluggish, fatigue/tired, nausea was not recovered, outcome of other events was unknown.
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| 53 | 2021-02-14 | nausea |
Body aches; fever - 100.8 degrees; chills; nausea; tired; This is a spontaneous report from a contac...
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Body aches; fever - 100.8 degrees; chills; nausea; tired; This is a spontaneous report from a contactable consumer. A 53-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9263) on his left arm, via an unspecified route of administration on 25Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included chronic lymphocytic leukaemia (CLL) and covid. The patient's concomitant medications were not reported. The patient experienced Body aches, fever - 100.8 degrees, chills, nausea, tired; all on 26Jan2021 06:30 AM. No treatment was received for the events. The outcome of the events was recovered on unspecified dates. No follow up attempts are possible. No further information is expected.
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| 53 | 2021-02-21 | nausea |
Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with fl...
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Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; nausea night of 2nd inj and next day; Severe fatigue; joint pain; I felt very ill; akin to the flu; This is a spontaneous report from a contactable nurse(patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 02Feb2021 11:45 AM at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient received the first dose of BNT162B2 on 15Jan2021 for covid-19 immunization and experienced syncope. The patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) methylfolate and Ma. The patient experienced syncope after injection in Feb2021. A few episodes in 18 hrs, the patient experienced headache, body aches, intermittent fevers with flushing/chills, nausea night of 2nd injection and next day in Feb2021. The patient experienced severe fatigue, joint pain, felt very ill, akin to the flu in Feb2021.No treatment received for the adverse events. The patient underwent lab test included body temperature: intermittent fevers in Feb2021.The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to the event syncope is possible based on available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 53 | 2021-02-22 | abdominal pain upper, diarrhea |
Aside from the usual chills arm pain aches and general malaise for 5 days , I?ve had more frequent ...
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Aside from the usual chills arm pain aches and general malaise for 5 days , I?ve had more frequent and looser stools and stomach cramping since the day of the vaccine .
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| 53 | 2021-02-22 | abdominal pain upper |
Shortly after the vaccine I developed chest tightness and SOB causing me to use my Albuterol Inhaler...
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Shortly after the vaccine I developed chest tightness and SOB causing me to use my Albuterol Inhaler. Later that evening I took my reg asthma meds. Sat morning still experiencing the SOB but a bad headache appeared and had some stomach aches as well. 1/9 I spoke with my Allergist who advised to take an additional Singulair and Xyzal meds on top of what I was originally taking already. 1/10 was advised to take and Allergra for the SOB along with my reg meds that evening and by the Tuesday of the next week I was finally able to get my back Asthma balanced out.
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| 53 | 2021-02-23 | diarrhea |
2/17 ; STARTED WITH CONGESTION/RUNNY NOSE AROUND 4:00 ; BY AROUND 5-6PM STARTED WITH CHILLS; HAD T...
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2/17 ; STARTED WITH CONGESTION/RUNNY NOSE AROUND 4:00 ; BY AROUND 5-6PM STARTED WITH CHILLS; HAD TWO BOUTS OF DIARRHEA THAT NIGHT; ARM OF INJECTION SITE HURT; WOKE UP AT 4:30 AM WITH HEADACHE ; STILL HAD CHILLS. EVERY JOINT IN BODY HURT; WOKE UP AROUND 10AM WITH CHILLS AND STILL HEADACHE; WALKING FELT LIKE MY LEGS WEIGHED 100 LBS A PIECE. I WAS VERY TIRED THE WHOLE DAY. STARTED GETTING ENERGY AROUND 7 PM ON 2/18. JOINTS STILL ACHY BUT NOT AS BAD.
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| 53 | 2021-02-23 | decreased appetite |
Symptoms of malaise, chills, fever, headache, and body aches and lose of appetite started about elev...
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Symptoms of malaise, chills, fever, headache, and body aches and lose of appetite started about eleven and one-half hours after 2nd injection. Treatment Tylenol and Benadryl.
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| 53 | 2021-02-24 | nausea |
Felt hot, burning sensation across chest, palpitations, dizziness, having sensation of everything...
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Felt hot, burning sensation across chest, palpitations, dizziness, having sensation of everything smelling sweet, tingling in hands and feet, hands shaking, slight nausea. Evaluated by EMS. Had not eaten given water and tea. Ate protein bar. Feeling better, symptoms resolved. Discharged home at 9:45am.
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| 53 | 2021-02-24 | diarrhea |
Pfizer COVID-19 Vaccine EUA Pt received 1st dose of vaccine on 1/31/21. Afterwards, she developed a...
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Pfizer COVID-19 Vaccine EUA Pt received 1st dose of vaccine on 1/31/21. Afterwards, she developed a slight cough and chest pressure. Pressure is worse with deep breathing. Denies chest pain. Denies SOB or wheezing. Pt also had episode of loose stool x 1. States she has had an anaphylactic reaction in past, but it did not feel the same. Pt took diphenhydramine 50 mg PO before receiving her vaccine after consulting her PCP. When pt presented to convenient care, vitals WNL. Pt given methylpredisolone 125 mg IM x 1. Pt prescribed epinephrine 0.3 mg injectable 2-pak kit. Provider recommended pt not receive the 2nd dose of vaccine unless PCP says otherwise. Pt discharged to home. 2/1/21: Pt continued to endorse loose stools, fatigue, and body aches. 2/2/21: Pt's PCP told her not to receive 2nd dose of vaccine.
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| 53 | 2021-02-24 | abdominal pain upper, decreased appetite |
Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, ch...
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Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, chills, sleepiness, severe pain in the arm of the vaccine, thirst, constant desire to urinate.
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| 53 | 2021-02-25 | decreased appetite, nausea |
Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; head...
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Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; headache; nausea; lack of appetite and energy; lack of appetite and energy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 10Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, High blood pressure, arthritis, obese, anxiety, depression. Concomitant medication included lamotrigine, duloxetine hydrochloride (CYMBALTA), ropinirole hydrochloride (REQUIP) and unspecified blood pressure meds. On 12Feb2021, the patient experienced raised swollen lump at injection site, muscle and joint aches, fatigue, headache and nausea, lack of appetite and energy. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has been tested for COVID-19, nasal swab on 04Dec2020: negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 53 | 2021-02-25 | nausea |
suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); suffering from a...
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suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); Headache; Chills; Nausea; swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686), via an unspecified route of administration on the arm/deltoid, on 07Jan2021, at single dose, for covid-19 immunization. Medical history included suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP). The patient had questions about some side effects from the COVID vaccine. She stated she received the first dose on 07Jan2021. About a week after that or maybe 7 to 9 days after the first shot, she started having side effects and was given a handout of a different side effects and risk of the vaccine and; she had like 4 or 5 of the side effects on Jan2021 such as headache, chills, nausea and swollen lymph node. She started with the headache initially then the chills, and nausea, and then lymph node. Her lymph nodes were still swollen. She informed was due to get the "booster" vaccine this Thursday (28Jan2021) and she just wanted to call and see if she should still go and get the booster vaccine with the swollen lymph nodes. She added she did get a test for the COVID this past Thursday (21Jan2021), because of the symptoms, and it was negative. She had the test because she didn't know if it was the vaccine side effect because the side effect also fell in line with actual COVID symptoms. She wanted to make sure that she didn't have the virus. At the time of the report she had not recovered from the adverse events headache, chills, nausea and swollen lymph node and she did not receive any treatment for these. The outcome of the other remaining events was unknown.
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| 53 | 2021-02-26 | nausea | Nausea, dizziness, aches, fatigue |
| 53 | 2021-02-26 | vomiting |
These symptoms were from the 2nd dose. Tenderness at injection site, fever, body aches, vomiting, se...
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These symptoms were from the 2nd dose. Tenderness at injection site, fever, body aches, vomiting, severe headache, fatigue, weakness - 3 days duration
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| 53 | 2021-02-28 | nausea, decreased appetite, diarrhea |
Diarrhea, nausea, headache, chills, fever,--within first 24 hours after receiving the second dose. N...
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Diarrhea, nausea, headache, chills, fever,--within first 24 hours after receiving the second dose. Nausea and fatigue persisted, along with the loss of appetite (as of this date, still no appetite...only being able to handle orange juice and saltine crackers); emotions are still a wreck; concentration level is still small; multi tasking is not doable; seem to lose words along the way in conversation.
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| 53 | 2021-02-28 | diarrhea |
First muscle soreness at site of injection, then severe redness at site, cherry electric red and pin...
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First muscle soreness at site of injection, then severe redness at site, cherry electric red and pink, severe muscle aches, severe joint aches, severe headache, diarreah, dizzyness, the extreme rapid heart rate of 205 BPM. SEVERE SVT, SUPREVENTRICULAR TACHYCARDIA lasting from 9 p.m. Friday evening through the a.m. until I was transported from Urgent Care via Paramedics to Emergency Hospital. I was given an IV of a Medicine to restart my heart twice. I felt like I was dying.
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| 53 | 2021-02-28 | vomiting, nausea |
I started with fatigue the afternoon of my 2nd vaccine. Slept from 3:40 that afternoon until the fol...
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I started with fatigue the afternoon of my 2nd vaccine. Slept from 3:40 that afternoon until the following morning at 5am. Body aches/mild. Worked the next day but had to leave an hour early due to fatigue and body pain. That evening developed nausea. (2-26). The 27th I had a terrible headache upon waking with increased nausea. Started vomiting around 10am. Unable to take in any liquid until that evening late. The 28th mild headache, more of a heavy headed feeling. Today, March 1st, nausea without vomiting thus far, weak & drained feeling.
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| 53 | 2021-02-28 | nausea |
Nausea; Dizzy; left arm soreness; This is a spontaneous report received from a contactable consumer ...
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Nausea; Dizzy; left arm soreness; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: May2021), intramuscular on the left arm, on 08Jan2021 16:29, at single dose, for Prevention/COVID-19 immunization, at a public health department. There were no medical history and concomitant medications. The patient did not receive other vaccinations within 4 weeks. On 09Jan2021 at 08:00, the patient experienced left arm soreness. On 27Jan2021 at 07:00, the patient felt dizzy. Shortly after, at 07:15, the nausea started. The patient wanted to know if these could be side effects and would it still be okay to get the scheduled second dose on 29Jan2021. The patient also asked if she can get the second dose if she has a fever on the day she is supposed to get the second dose. The events did not require emergency room or physician's office visits. The patient was recovering from the events. The reporter assessed the events as non-serious.
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| 53 | 2021-03-16 | nausea |
Immediate onset Rapid heartbeat, headache, nausea, extreme immediate fatigue onset Treatment: Atara...
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Immediate onset Rapid heartbeat, headache, nausea, extreme immediate fatigue onset Treatment: Atarax, benadryl, extra strength Tylenol, Hydrochloathiazide
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| 53 | 2021-03-17 | nausea |
neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM...
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neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM PAIN AND JOINTS/PAIN PROGRESSING TO CONSTANT SEVERE PAIN AND HAS MOVED INTO UPPER ARMS WITH PAIN WORSENING DAILY; BILATERAL LOWER ARM PAIN AND JOINTS; SWOLLEN LYMPH NODES IN ELBOWS; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284, expiration date: not reported) intramuscular in the arm left on 01Feb2021 08:00 at single dose for COVID-19 immunisation. Patient medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and lamotrigine (LAMICTAL). The patient previously took codeine and experienced allergic reaction to drug; naproxen and sulfur and experienced drug allergy. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at the hospital. On 02Feb2021 06:00, the patient experienced neuropathy in left foot, headaches/intermittent headaches, nausea, muscle aches, bilateral lower arm pain and joints, swollen lymph nodes in elbows, pain progressing to constant severe pain and has moved into upper arms with pain worsening daily. No treatment received for the adverse event. Outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event neuropathy peripheral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 53 | 2021-03-24 | vomiting, diarrhea, nausea |
Pfizer-BioNTech COVID-19 Vaccine EUA 24-48hrs after: injection site pain spread to whole-body muscle...
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Pfizer-BioNTech COVID-19 Vaccine EUA 24-48hrs after: injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious/choking amounts of mucous from nose & throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F), sweating, chest pressure & back pain on left side from waist to neck, difficulty breathing, severe insomnia. 48-72hrs after: all of the above EXCEPT coughing/sneezing/mucous/vomiting/diarrhea. Soft stools w/loss of bowel control. Growing anxiety due to chest pressure/back pain on left side from waist to neck, difficulty breathing & severe insomnia.
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| 53 | 2021-03-27 | appendicitis | Acute appendicitis. Urgent care for diagnosis. Appendectomy 3/14, 7:45 pm. |
| 53 | 2021-04-01 | difficulty swallowing |
difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; difficulty s...
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difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; had a lot of mucus in my throat; difficulty breathing; asthma acting up; lethargic; dehydrated; headaches; immobility; fever; chills; muscle aches; stiffness; electrical shocks up and down my body; fatigue; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:00 (Batch/Lot Number: EN6202), at the age of 53-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, multiple sclerosis, seasonal allergies, dust, animals. The patient did not have COVID prior vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included glatiramer acetate (COPAXONE); lamotrigine (LAMICTAL); risperidone (RISPERDAL); alprazolam (XANAX); salbutamol (ALBUTEROL HFA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took dilaudid and experienced allergies. On 04Mar2021 17:00, the patient got fever, chills, headaches, muscle aches and stiffness. The patient treated the symptoms with ibuprofen and ice packs. The next day, on 05Mar2021, the patient had difficulty swallowing, chewing and speaking. The patient had a lot of mucus in my throat and difficulty breathing from asthma acting up. The patient was very lethargic and dehydrated. The patient had to use inhalers, benedryl and musinex to treat symptoms. The patient had the chills, headaches, fever and aches through Tuesday, 09Mar2021. The patient touched base with her general practitioner's and neurologists' offices on March 5 & 6 and left messages. They suggested she go to the ER. (She didn't go out of fear of getting COVID), she was too fatigued and weak to walk. No balance. She had electrical shocks up and down her body. The patient was still experiencing immobility and fatigue. The outcome of the events chills, headaches, fever and aches was recovered on 09Mar2021; the other events were not recovered. The patient was not tested for COVID post vaccination.
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| 53 | 2021-04-05 | abdominal distension, abdominal pain upper |
I received the first covid vaccine on 1/4/21 and the 2nd on 1/25/21. On Feb 22nd I started having h...
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I received the first covid vaccine on 1/4/21 and the 2nd on 1/25/21. On Feb 22nd I started having heavy vaginal bleeding and severe stomach cramps. These continued for 9 days and then I went to the Emergency department because I felt like my HGB was low. They checked it and it was 11.3 and did an abd US that showed my endometrium was thick. They recommended follow up with GYN and a biopsy. I continued to have significant bleeding and cramps until the next week when I called the nurse line and they set me up with a virtual visit with GYN provider. She started me on progesterone and scheduled a hysteroscopy and D & C for the following week. The progesterone slowed the bleeding down but I continued to experience abd cramps. I had the D & C and after getting home started to have heavy bleeding and bad cramps again. The following week I called the GYN provider and she had me come in for another Abd US and checked my HGB which was 9.3. She also checked for infection and other labs which were all within nml range. The pathology from my D & C was neg and the GYN really was not worried that is was anything other than a period but was surprised that it was lasting so long. She gave me TXA and after 5 days on that the bleeding has now stopped but I am still having bad cramps in my lower abd and a lot of bloating. Also having lots of jolting pains in lower abd. I have never had periods that were anything like this and never really had bad cramps like this before.
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| 53 | 2021-04-06 | appendicitis |
Acute appendicitis; Appendix had small rupture; This is a spontaneous report from a contactable cons...
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Acute appendicitis; Appendix had small rupture; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration in arm left, on 08Mar2021 at 12:00 (Lot Number: EN6199), as single dose, for COVID-19 immunisation. Medical history included hypothyroidism and COVID-19. The patient had not known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced acute appendicitis (caused hospitalization for 1 day, life threatening) on 12Mar2021 at 10:45 with outcome of recovering and appendix had small rupture (caused hospitalization for 1 day, life threatening) on 12Mar2021 at 10:45 with outcome of recovering. Therapeutic measures were taken as a result of the events. Since the vaccination, the patient has not been tested for COVID-19. Follow-up information has been requested.
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| 53 | 2021-04-08 | nausea |
site of injection, LUA, muscle soreness and unable to life L arm. Still unable to life left arm com...
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site of injection, LUA, muscle soreness and unable to life L arm. Still unable to life left arm completely without pain. I'm a nurse, so doing my own physical therapy. BUT, main issue has been daily headaches. I've had more headaches in the last 3 months since vaccine, then I have had in my entire life. no treatment except Tylenol or ibuprofen. Although, the other day I had a severe headache, with visual disturbance, vertigo with dizziness and nausea. Was treated at local ER for possibly stroke. MRI showed no issues. I am now diagnosed with migraines.
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| 53 | 2021-04-09 | diarrhea, nausea, vomiting |
Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache;...
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Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache; Coughing; Sneezing; Copious amount of mucous from nose/throat; Copious amount of mucous from nose/throat; Nausea; Vomiting; Diarrhea; Chills; Lightheaded/dizzy; Fever (99.1-99.3F); Sweating; Chest pressure; Back pain on left side from waist to neck; Difficulty breathing; Severe insomnia; Soft stools with loss of bowel control; Soft stools with loss of bowel control; This is a spontaneous report from a Non-contactable consumer (herself reporting). This 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiry date: Not reported) via an unspecified route of administration in left arm on Mar2021 as a single dose for COVID-19 immunisation. The patient was allergic to mycin,neosporin/bacitracin. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior vaccination. After 24 to 48 hours of vaccination the patient experienced injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious amount of mucous from nose/throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F)/sweating, chest pressure and back pain on left side from waist to neck, difficulty breathing, severe insomnia. After 48 to 72 hours of vaccination the patient experienced Soft stools with loss of bowel control. Growing anxiety due to chest pressure and back pain on left side from waist to neck, difficulty breathing and severe insomnia and all the above events except coughing, sneezing, mucous, vomiting and diarrhea and the patient was sent to emergency room/department or urgent care and hospitalized for one day. The patient received IV, EKG (electrocardiogram), blood panels, X-ray, Ibuprofen, Ativan (lorazepam) as treatment for the events. The patient underwent unknown COVID test post vaccination in ER (emergency room) which shown negative result. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-04-12 | abdominal pain |
Presented to the ER on 12/18/2020 with abdominal pain. Was diagnosed with cecal volvulus and underwe...
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Presented to the ER on 12/18/2020 with abdominal pain. Was diagnosed with cecal volvulus and underwent exploratory laparotomy with right colectomy on 12/19/2021.
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| 53 | 2021-04-12 | diarrhea |
Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/...
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Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/was very pale and noted shaking. EMT took BP which was high (I'm typically on lower end of average). Observed me for 45 minutes as BP came down to normal range and asked if wanted to go to hospital. Declined as had appointment later that day with my electrophysiologist at Hospital. As day went on, became increasingly tired and had bouts of uncontrollable shaking. Thought it would wear off so just went home to rest. On 3/31/21, BP was high again, tremors were getting worse, had leg weakness, double vision, brain fog, dropping things, loose stools, felt off. Went to Hospital and was admitted for 3 days. Neurloigst, Dr., said it was due to Covid vacccine and NOT to get the second shot, and the hospital internist agreed (MRI of brain and cervical spine showed no new lesions). Wanted todo heart procedure but they are not my private cardio group so checked myself out and went to Hospital the next day (admitted 4/3-4/5/21)
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| 53 | 2021-04-17 | diarrhea, abdominal pain upper |
the contractions and cramping sensation went trough out her entire chest region and her back (like h...
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the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms); the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms; in the left arm it was cold and tingling; in the left arm it was cold and tingling; experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours; diarrhea on the weekend; strong cramps in her stomach (stomach flu-like symptoms); This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration in Arm Left on 23Mar2021 (Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. Medical history included ischemic colitis in the past and she thinks that maybe the cramping started triggering it again. The patient's concomitant medications were not reported. On 02Apr2021 strong cramps in her stomach (stomach flu-like symptoms) and on an unspecified date, the patient experienced the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms), in the left arm it was cold and tingling (vaccination site coldness), (paraesthesia), experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours (muscle spasms) and diarrhoea on the weekend. Her second dose is scheduled on 13Apr2021, she would like to know if there are recommendations for her second dose because she heard that with the second dose the side effects are worse, she would like to know if someone else has reported these symptoms. She would like to know if she should possibly receive the vaccine in her thigh instead of her arm and if that would be helpful. The outcome of the events diarrhoea was recovered on 05Apr2020 and outcome of contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms) was not recovered and rest of the events was unknown. Information on the Lot/Batch number has been requested
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| 53 | 2021-04-24 | nausea |
diverticulitis; Dizziness; nausea; general unwell; affected my sense of taste; After losing part of ...
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diverticulitis; Dizziness; nausea; general unwell; affected my sense of taste; After losing part of her sense of smell since Mar2020, it came back really strong; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 31Mar2021 16:00 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Medical history included diverticulitis, abscess in back at the moment of the vaccination, and losing part of her sense of smell from Mar2020. There were no concomitant medications, and vaccines in four weeks. The patient experienced dizziness, nausea and generally unwell. Two days after receiving the vaccine, on 02Apr2021 15:00, patient was in the ER with diverticulitis. She had to take Ciprofloxacin and metronidazole. After losing part of her sense of smell since Mar2020, it came back really strong. It affected her sense of taste and all food taste bad now. It was like pregnancy sickness. Her sense of smell came in an estrange manner. The events were experienced on 02Apr2021 15:00. Outcome of the events was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.
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| 53 | 2021-04-24 | diarrhea |
rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating pr...
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rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating profusely; temp of 101; trembling uncontrollable; freezing; terrible headache; lethargic; This is a spontaneous report from a contactable consumer (who is also the patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm, on 07Apr2021 10:30, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) received at age 53 years, via an unspecified route of administration in the left arm, on 16Mar2021 11:00, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 08Apr2021 at 03:30, the patient woke up trembling uncontrollable and was freezing. She had a terrible headache. At about 04:30, the patient got out of bed to get some Advil and go to the bathroom. She almost got to the bathroom but was unable to hold her urine and had sudden diarrhea as soon as she sat down. She then became extremely weak and passed out. She was sweating profusely and had a temp of 101. She took Tylenol and Advil and her temp broke an hour or two later. She then had a headache and was lethargic all day on 08Apr2021. On 09Apr2021, the patient felt much better but reported she was still weak, she also had a rash covering most of her torso. Treatment for the events trembling uncontrollable, freezing, terrible headache and temp of 101 included Tylenol and Advil. No treatment was taken for the remaining events. The outcome of extremely weak was not recovered; and the outcome of the remaining events was recovering.
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| 53 | 2021-04-26 | nausea |
This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her...
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This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 11Apr2021 09:15 (Lot Number: EP7533; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 53 years). Medical history included asthma, Blood pressure high, acid reflux , allergies: Sulfa, Lactose intolerant and allergies: Latex. The patient's concomitant medications were not reported. The patient had a historical vaccine of Flu shot (INFLUENZA) on an unspecified date for immunisation and experienced bad side effects. The patient previously took bactrim, minocycline, doxycycline, ciprofloxacin, Moxifloxacin, demerol, avelox, nitrofurantoin, naprosyn, motrin, perocet, tramadol and aleve and experienced allergies. The patient experienced anaphylaxis on 11Apr2021. It was also reported that she had an appointment for COVID Vaccine at 9:15AM. Received COVID Vaccine and was told to wait for 30 minutes. Within 10 minutes her chest starting getting tight with difficulty of breathing. Her throat was closing up, and she was light headed. She explained this to the administrator who asked if caller could get up to see the paramedic. As caller tried to stand up, she almost passed out. Had to sit there for a second and the second time was able to get up and made it in to the room. Was going in and out of consciousness. Had to stab her with an Epi Pen. She couldn't breathe. Her throat was closing up. Her tongue was swollen. She was in and out of consciousness. First Epi Pen didn't work. An IV was put in and was given something through it. She was jabbed with a second Epi Pen. Was still in and out of consciousness but she was starting to come back. Was given oxygen and a nebulizer. She does have asthma. Ambulance was called. Was told she was worked on for 20 minutes. When ambulance arrived she was able to get up and get on the cart. She was taken to the hospital. Was given medicine through her IV. Had to be kept at hospital because she had two Epi Pens and medication at the vaccine facility. Hospital wanted to make sure when the Epi Pens wore off she didn't go back into anaphylaxis. Was kept in ER for over four hours. Was given IV fluids. Her oxygen, heart rate, and blood pressure dropped at vaccination facility. Oxygen was 81. Blood pressure was 94. At hospital, her levels started to get better. Once she was given the second Epi Pen and whatever else she was given, the medication started to work and she had come through. At the hospital, someone came in and did bloodwork for research to see why this happened. Was prescribed Epi Pens by the doctor in the hospital and was advised to carry Epi Pens with her at all times. If she has another anaphylaxis, was advised to jab herself with Epi Pen and call right away. Was told her tongue was swelling. Attempted to obtain the outcome of the anaphylaxis. At the hospital, she was so out of breath walking to the bathroom. Was told at hospital now she is having side effects from the COVID Vaccine including the tiredness and headache she is experiences. Was told to take Tylenol and Benadryl, lay down and rest, and to make sure she drinks so she does not get dehydrated. Today, she feels nauseous, lightheaded and tired with a little headache. She feels better from yesterday. Is getting better and is having a little chills maybe an hour ago. She checked her temperature and does not have a temperature, but her insides feel warm . The patient was hospitalized for the event anaphylaxis on an unspecified date. Therapeutic measures were taken as a result of was going in and out of consciousness. Events for anaphylaxis, consciousness fluctuating, chest discomfort. dyspnea, throat tightness, presyncope and swollen tongue occurred on 11Apr2021 while the remaining events occurred on an unspecified date. The patient underwent lab tests and procedures which included blood pressure: dropped and 94, blood work: unknown results, heart rate: dropped, oxygen saturation: 81 and dropped on an unspecified date. Therapeutic measures were taken as a result of all the events. Outcome of the events was unknown.
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| 54 | 2021-01-01 | nausea, diarrhea | Body aches, fatigue, arm pain(first couple of days), diarrhea and nausea |
| 54 | 2021-01-01 | nausea |
Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe head...
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Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe headache, muscle and joint pain, chills, fever (temperature-102.8),and exhaustion. Redness, pain, and swelling at injection site that has continued to worsen even after 48 hours. Could not perform regular activities of daily living. I could not drive home from work the day after the injection because the adverse reactions were getting more severe, especially after the 24 hour mark. Treatment: treated my symptoms at home with medications (I am a nurse), after researching possible adverse reactions. I figured there was not anything someone else would to treat me besides treat my symptoms.
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| 54 | 2021-01-02 | nausea |
5pm 12-29-2020 slight headache, that lasted through Wednesday evening, 12-30-2020. Thursday, 12-31-...
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5pm 12-29-2020 slight headache, that lasted through Wednesday evening, 12-30-2020. Thursday, 12-31- 2020, no adverse reaction. Friday, 1-1-2021 , entire body, including internal organs were trembling. Saturday, 12-31-2020, extremley dizzy, unable to stand, function. Nauseated, extremely dehydrated, extreme exhaustion. This lasted 24 hours. Sunday, 1-3-2020, still exhausted, but not to extreme. All other symptoms have subsided.
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| 54 | 2021-01-03 | nausea |
12/31/20 - cough, sneezing, weakness. Felt ill all weekend. 1/3/21 - called Employee Health with lo...
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12/31/20 - cough, sneezing, weakness. Felt ill all weekend. 1/3/21 - called Employee Health with low-grade fever, chills, nausea, weakness and elevated blood pressure 165/104, which had come down by the afternoon to 155/95
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| 54 | 2021-01-03 | abdominal pain upper |
I got Pfizer vaccine on 12/29. Had muscle soreness at site, Stomach cramp same day after 35 mins of ...
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I got Pfizer vaccine on 12/29. Had muscle soreness at site, Stomach cramp same day after 35 mins of shot. Mild lower back pain that evening (vaccine on left arm and pain on same side). On 12/30 soreness was only to palpation. Rhinorrhea all day long, took NyQuil, moderate back pain, took naproxen and did some back stretches. On 12/31 no sore arm but little tender. Increased back pain , used back brace , took naproxen not that much help though. used heat pack finally fall asleep around 3 am. on 01/01/2121 around 6 am woke up with excruciating left lower back pain, could not move, get off the bed. took a while to get off the bed. Have to drag my legs very slowly to walk. Went to ER. X-ray did not show anything. In ER took Narco 5 and Baclofen. MD thinks that it might not be side effects of vaccine. But I wonder, I never had left lower back pain before. Taking Baclofen and Advil TID since 0101/2021. 01/04 still in pain. increase pain after 6-7 hours after meds. Sitting or standing more than 30 mins Increases pain. Going to see PMD today
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| 54 | 2021-01-04 | difficulty swallowing |
About 49 hours after receiving the Pfizer mRNA COVID-19 vaccine, patient developed chest tightness, ...
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About 49 hours after receiving the Pfizer mRNA COVID-19 vaccine, patient developed chest tightness, itchy throat, upper and lower eyelid swelling, lip swelling, difficult swallowing. Selt-treated with prednisone 40mg, fexofenadine 1 tablet, famotidine 40mg, albuterol breathing treatment. Felt better, but then 6-8 hours later, felt chest tightness again that did not resolve with breathing treatment. Went to the Hospital Emergency Department. No epinephrine was administered. But received IV corticosteroids, diphenhydramine and famotidine, and was discharged with 6 days of oral corticosteroids
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| 54 | 2021-01-04 | diarrhea, decreased appetite |
Since 4pm Tuesday 29th, extremely lethargic, sleeping heavily and wet productive cough with clear sp...
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Since 4pm Tuesday 29th, extremely lethargic, sleeping heavily and wet productive cough with clear sputum. No fever, has had body aches, lethargy, malaise, fatigue, bloodshot eyes and diarrhea, loss of appetite.
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| 54 | 2021-01-04 | nausea |
Started to feel dizzy about 9 hours after the injection. Went to bed. Woke up 8 hours later with a...
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Started to feel dizzy about 9 hours after the injection. Went to bed. Woke up 8 hours later with an extreme headache 9/10 and nausea. Took 325 Tylenol and brought the pain down to a 7/10. Slept for a couple of hours and woke up with a headache at a 7/10 - took 650 mg Tyleno, drank some Focus Aid and ate some veggie straws. After about 1/2 hour the headache was down to a 4/10,
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| 54 | 2021-01-04 | nausea |
Started to feel dizzy about9 hours after the vaccine. Went to bed. Woke up at 6:20 AM with nausea ...
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Started to feel dizzy about9 hours after the vaccine. Went to bed. Woke up at 6:20 AM with nausea and a tremendous headache - 8 out of 10. Took 325 mg Tylenol and helped a little - 7 out of 10. Slept a couple of hours and the headache was still 7 out of 10. Took 650 mg Tylenol, ate some veggie straws, and drank some Focus Aid. After about 1/2 hour the headache was a 4/10. 2 hours later and headache remains, currently 5/10.
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| 54 | 2021-01-04 | nausea, vomiting | Vertigo, Positional Vertigo, Nausea/Vomiting |
| 54 | 2021-01-04 | nausea |
she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/Sh...
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she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/She just took it now and it is 100.4 degrees Fahrenheit; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer reporting for herself. A 54-y ears-old female patient received bnt162b2 (BNT162B2) vaccine, intramuscular in the right arm on 23Dec2020 07:00 at single dose for covid-19 immunisation . Medical history included covid-19 from Jul2020 to an unknown date. There were no concomitant medications. The patient experienced chills on 24Dec2020 with outcome of recovering , nausea on 23Dec2020 23:00 with outcome of recovering , headache on 24Dec2020 with outcome of recovering , running temperature at 100.4 degrees Fahrenheit on 24Dec2020 with outcome of not recovered , feeling unwell on 23Dec2020 with outcome of not recovered , resting heart rate went to 130 on 24Dec2020 with outcome of recovering , she could not stop shaking on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 99.8 Fahrenheit; 99.2 Fahrenheit, 100.4 Fahrenheit, heart rate: 130 (66-72. Normally) , sars-cov-2 test: negative on 21Dec2020 , sars-cov-2 test: negative on 24Dec2020 . Information on the lot/batch number has been requested.
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| 54 | 2021-01-05 | nausea | I had off and on body aches and a pretty severe headache for three days but no fever but nausea. |
| 54 | 2021-01-05 | retching, vomiting, nausea |
One week after the vaccine I was find until....I got out of my car after driving and started stagger...
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One week after the vaccine I was find until....I got out of my car after driving and started staggering and could not function. Severe dizziness, heavy headedness , nausea and vomiting and a horrible headache. My husband had to physically muscle me back to my car. He wanted to take me to the ER and I would not let him because of the waiting room is full of COVID positive patients. I threw up along the way home and multiple times to the point I had drive heaves. I am a Registered Nurse and felt the symptoms I were experiencing were Vertigo. I had one bout with Vertigo in 2015 and it was extreme. I had Meclizine on hand and and took one tablet and slept. The severity of this was so bad I could not walk unassisted or sit up without falling over. After 6 hours of sleeping I got up, dizziness continued, and vision a little off. I still do not feel 100% I have had a headache since. It never dawned on me this could be from the vaccine I had taken a week before.
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| 54 | 2021-01-06 | nausea, vomiting, diarrhea |
Headache, Myalgia, Diarrhea, NauseaVomiting, injection site soreness initially, then on the 30th ar...
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Headache, Myalgia, Diarrhea, NauseaVomiting, injection site soreness initially, then on the 30th arm was very sore, runny nose, shoulder/neck aches, severe N/V/D, severe fatigue Narrative: Did not need to seek medical care. Stayed at home.
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| 54 | 2021-01-06 | vomiting, nausea | NauseaVomiting dizziness |
| 54 | 2021-01-06 | vomiting, abdominal pain upper | Stomach cramps and vomiting. Vomited once then felt fine. Resolved in one day. |
| 54 | 2021-01-06 | nausea |
Sxs 90 minutes post vax. SOB, palpatations, nausea, tachycardia. Presented to ED. CXR/EKG normal, l...
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Sxs 90 minutes post vax. SOB, palpatations, nausea, tachycardia. Presented to ED. CXR/EKG normal, labs normal, given Zofran inj.
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| 54 | 2021-01-06 | nausea |
her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her le...
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her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her left side, a cold spike feeling up her shoulder and neck and up to her face; upper esophageal sphincter got tight and felt funny like she was going to throw up; her whole body was shaking- her head, hands, and legs; feeling giddy; blood pressure was up; being stressed; was going to throw up/transient nausea; felt a little funny; This is a spontaneous report from a contactable Nurse(patient). A 54-year-old female patient received BNT162B2 (lot number EL0140), via an unspecified route of administration at left deltoid on 30Dec2020 14:28 at the 54 years old at 0.3 mL single for where she works she was exposed to patients who need rehab that were exposed and getting COVID. The patient medical history included Primary Essential Tremors and ongoing (had these for about 10-11 years. Her mother and grandmother also had them. Normally they were very fine, small tremors that people didn't notice. She can hold and turn her head and hide it) and Sulfa drug allergy (would get shortness of breath). The concomitant product was none. The patient previously took flu vaccine and experienced preservative made neck twitch and joint sores. Yesterday the patient got the COVID Vaccine and had a pretty significant adverse event. She was calling to report it and to see if she should get the second dose of the vaccine. The patient was also a licensed speech pathologist. She received the vaccine yesterday at 2:28 PM. She was allergic to Sulfa drugs and would get shortness of breath, so they wanted her to wait 30 minutes for monitoring. She was feeling giddy on 30Dec2020, but she ran into a friend that she had not seen before quarantine, so they were talking. It was exciting. After her 30 minutes she went to her car and felt a little funny. She thought she was hungry so she ate half a banana and had some water. She had an appointment to get to so she started to drive off, and by the time she got to the interstate she was feeling funny. She got on her left side, a cold spike feeling up her shoulder and neck and up to her face on 30Dec2020. This was like the precursor. Then on 30Dec2020 her face started to go numb. It felt like a dental block you would get with Lidocaine. It went from her temple area, below her eye all the way to her lips. It was midline on the left side. She was breathing fine. She was trying to figure out if she should pull over or call(Number), but her airway did not close up. Her upper esophageal sphincter got tight and felt funny like she was going to throw up. She drove to the hospital close to her house which is affiliated with where she got the vaccine. She normally had primary tremors, small to where people do not notice. But her whole body was shaking- her head, hands, and legs on 30Dec2020. She looked like a bobble head. But she could still breath. They took her right in and they did an EKG to make sure it was not her heart. Her blood pressure was up on 30Dec2020, she assumes for being stressed. They monitored her. They gave her Pepcid and Benadryl. She did not want any nausea medications. She stayed for about 2 hours and slept some from the Benadryl. Her face slowly became less numb. The numbness went away started from her lips and outward to her check and temple area. Then it just felt funny. When she touched it, which she never lost sensation, it was like, whose face is this? It was strange. She is not numb anymore. It took a while for it to go away, and it still felt weird. When she woke up this morning it was completely gone. She had recovered completely from all of these things. The only thing she has now was some transient nausea. It was very mild. It comes and goes. It had improved. She had not taken anything for it. The events Feeling funny, her face started to go numb, upper esophageal sphincter got tight, a cold spike feeling up her shoulder and neck and up to her face, Her whole body was shaking- her head, hands, and legs, were all assessed as Medically significant. The outcome of the event Nausea was recovering, the events Felt giddy, blood pressure was up, Stress was recovered on 31Dec2020, the other events were recovered on 30Dec2020. The reporter considered there was a reasonable possibility that the events Feeling funny, a cold spike feeling up her shoulder and neck and up to her face, Face started to go numb from her temple area, below her eye all the way to her lips, upper esophageal sphincter got tight , whole body was shaking- her head, hands, and legs, Nausea, were related to the product BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-07 | diarrhea, nausea |
Chills; fever; fatigue/tiredness; headache; body aches; diarrhea; nausea; This is a spontaneous repo...
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Chills; fever; fatigue/tiredness; headache; body aches; diarrhea; nausea; This is a spontaneous report from a contactable pharmacist (patient). A 54-year-old female patient received her first dose of BNT162B2 Lot # EJ1685, via an unspecified route of administration at Arm Left on 30Dec2020 11:00 at single dose for COVID -19 immunization. Medical history included Hypothyroid. She was not pregnant. There were no known allergies. Concomitant medication in two weeks included levothyroxine, mometasone furoate (FLONASE), ibuprofen, iron, biotin, and unspecified "B". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Started 03Jan2021 10:00 AM, the patient experienced chills, fever, fatigue, tiredness, headache, body aches, nausea, diarrhea resulted in [Doctor or other healthcare professional office/clinic visit]. No treatment was received for all events. The patient did not have Covid prior vaccination and Covid was not tested post vaccination.The outcome of all the events was not resolved. The pharmacist considered all the events as non-serious.
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| 54 | 2021-01-07 | nausea | Extreme fatigue, swollen lymph node near collarbone, nausea on day two post second vaccination |
| 54 | 2021-01-07 | nausea | Fatigue ,chills,headache, nausea,lightheaded |
| 54 | 2021-01-07 | nausea | Fatigue, headache, nausea, and body aches |
| 54 | 2021-01-07 | vomiting, nausea, diarrhea |
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting & Tachycardia Narrative: Vaccine received on 12-1...
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Headache, Myalgia, Fever, Diarrhea, NauseaVomiting & Tachycardia Narrative: Vaccine received on 12-19-20. Symptom onset several hours later, needed to miss work on Monday 12-21-20 on account of symptoms. No immediate medical intervention required. Self-managed with tylenol.
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| 54 | 2021-01-07 | nausea | Headache, nausea |
| 54 | 2021-01-07 | nausea |
Injection site pain; Tiredness; Muscle pain; Chills; Fever; Nausea; Feeling unwell; This is a sponta...
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Injection site pain; Tiredness; Muscle pain; Chills; Fever; Nausea; Feeling unwell; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EJ1685, Expiration 31Mar2021) solution for injection in the left arm on 02Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. On 03Jan2021 at 02:00, the patient experienced injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell. Treatment was provided for the events injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell included ibuprofen. The outcome of the events injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell was unknown. There was no physician office/ emergency room visit.
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| 54 | 2021-01-07 | nausea |
Severe bilateral headache and chills with nausea and unlike any headache I have ever had. Treaty wit...
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Severe bilateral headache and chills with nausea and unlike any headache I have ever had. Treaty with Goody headache powder, 2 vicodin and 16 hours of sleep. Outcome, it went away though I missed a day of work.
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| 54 | 2021-01-07 | vomiting, nausea | body aches, vomitting for 12 hrs, nausea |
| 54 | 2021-01-07 | nausea |
dizziness; severe weakness; fevers of 102.8; muscle and body aches; muscle and body aches; chills; c...
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dizziness; severe weakness; fevers of 102.8; muscle and body aches; muscle and body aches; chills; cold-clammy skin; headache; exhaustion; nausea; Redness and swelling at injection site that is still getting more severe after 48 hours; Redness and swelling at injection site that is still getting more severe after 48 hours; This is a spontaneous report from a contactable nurse reporting for self. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899, intramuscularly from 30Dec2020 13:00 (age at vaccination: 54 years old) at single dose in left arm (dose 1) for COVID-19 immunization. There was no other vaccine administered in the 4 weeks prior to COVID vaccination. The patient was not pregnant. Medical history included hypertension, arthritis, degenerative disc, CRPS/RSD, thyroid cancer, thyroidectomy during 2007, and Crohn's disease. Known allergiesincluded insect stings and environmental allergies. The patient had COVID prior to vaccination. Concomitant medication included thyroid (THYROID); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN); hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ); meloxicam (MOBIC); vitamin D; alpha lipoic acid (ALPHA LIPOIC ACID); duloxetine hydrochloride (CYMBALTA); and pantoprazole sodium sesquihydrate (PROTONIX). Within 24 hours of receiving COVID vaccine, the patient experienced dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, and nausea, from 31Dec2020 at 08:00. These continued to worsen over the next 24 hours. Redness and swelling at injection site that was still getting more severe after 48 hours. The patient was unable to drive home from work the day after injection due to adverse reactions getting worse throughout the day. The patient self-treated at home with medications (not further specified). The outcome of the events dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, nausea, and redness and swelling at injection site were not recovered. The events were reported as non-serious. The patient was not COVID-tested post-vaccination.
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| 54 | 2021-01-07 | nausea | fever, body aches, Heache, does not feel well, nausea |
| 54 | 2021-01-07 | vomiting |
throwing up; fever; body aches; her whole intestines hurt; it was horrible; thought she had contract...
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throwing up; fever; body aches; her whole intestines hurt; it was horrible; thought she had contracted COVID-19; thought she had contracted COVID-19; tired; This is a spontaneous report from a contactable consumer. A 54-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140), via an unspecified route of administration on left arm on 17Dec2020 at 19:15, at a single dose for vaccination. Medical history included ongoing ulcerative colitis, onset date was unknown, but when she was about 25 years of age. Concomitant medication included ongoing azathioprine for ulcerative colitis, started probably 5-10 years ago and taken daily since. In the past, she took different products for ulcerative colitis off and on when she had an episode. This patient reported she was administered her first Pfizer COVID-19 Vaccine injection on 17Dec2020 and was just kind of tired on 17Dec2020; but she had onset of serious reactions to the COVID-19 Vaccine starting 18Dec2020 for 2 days straight and then as suddenly as the events started they suddenly stopped after 2 days with no lasting effects. She called to ask if there is any data about if the second dose of the COVID-19 Vaccine will be just like the first shot or if the events are just hit or miss; she is really hoping not to be that sick again with the second dose. Serious reactions to the COVID-19 Vaccine further described as sick for like 2 days straight. Afternoon of 18Dec2020 she was throwing up; had fever; body aches; thought she had contracted COVID-19 in between injection and onset of symptoms; she had no lung issues; her whole body hurt; she could not stop throwing up; her whole intestines hurt; it was horrible; she could not hold anything down for like 2 straight days and then just left on 20Dec2020. Scheduled date for second dose was on 06Jan2021, she has no plan to change dose schedule. The outcome of the event of tired recovered in Dec2020, while other events recovered on 20Dec2020.
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| 54 | 2021-01-08 | decreased appetite |
12/31--slight headache that morning, by that evening migraine level headache 01/01/21-early morning ...
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12/31--slight headache that morning, by that evening migraine level headache 01/01/21-early morning fever 101.9, severe chills, severe aches of lower back, hips, joints, loss of appetite these symptoms continued thru 01/02/21 01/03/21 fevere abated, still body aches but much less severe, fatigue 01/04/21 fatigue only slowly resolving
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| 54 | 2021-01-09 | vomiting |
Day. 6: fever, headache , intense body aches more on the right side. Vomited once but tensioned na...
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Day. 6: fever, headache , intense body aches more on the right side. Vomited once but tensioned nauseous. Day 7: symptoms worsened . I had a fever throughout the night but fever broke my morning Day 8 post vaccine, feeling much better, no fever. I recognize these symptoms aren?t life threatening and I could have been exposed to covid after the vaccine, I don?t know. I?m just trying to help get the data out there for the pharmaceutical companies and the public to have
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| 54 | 2021-01-09 | abdominal pain upper, diarrhea | Diarrhea lasting for 22 day, RIGHT UPPER QUADRANT pain for 22 days |
| 54 | 2021-01-09 | nausea |
Patient received 2nd dose of covid vaccine 1/9/2020 around 1100. Report having mild reaction (flu-l...
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Patient received 2nd dose of covid vaccine 1/9/2020 around 1100. Report having mild reaction (flu-like sx) with first dose. She began experiencing feeling like she was outside of her body about 10 min after receiving her booster. BP was taken and was slightly elevated 140s/90s. Ice packs were provided for hot flashes. Warm blankets provided for chills. BP was trending up to SBP 160s then started to decline to normal. Patient was accompanied to restroom by clinic staff and was able to walk without incident. Patient was observed in covid clinic for total of 2 hours and reassured that she was not likely to have worsening of sx at this point. Patient was walked to mother's car by clinic staff and left feeling better. 1/10 - patient presented to ED with low grade fever (100.4), chest pain, severe joint and muscle pain, nausea and "fog brain." She reports BP being 187/101 in ED. Given 1L of normal saline, zofran, toradol, and dilaudid. Observed until BP drcreased to SBP 140s. Nausea improved enough to allow her to eat. Labs were WNL, CK normal. Discharged home with diagnosis of "adverse effect of COVID-19 vaccine"
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| 54 | 2021-01-09 | nausea | Pfizer-BioNTech COVID-19 Vaccine. Chills, headache, body aches, nausea, fatigue |
| 54 | 2021-01-10 | nausea |
Extreme headache and nausea. Headache started on 1/8/21 about 6pm and lasted a couple of hours. Sat...
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Extreme headache and nausea. Headache started on 1/8/21 about 6pm and lasted a couple of hours. Saturday 1/9, just had tenderness to injection site until 1030pm when the headache returned. Hurt to move my head. Woke up on 1/10, extreme headache and nausea. Hurt to move head and was nauseated whenever I bent over.
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| 54 | 2021-01-10 | abdominal discomfort |
Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps ...
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Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps in arms and legs. Feelings of restless, stomach upset. Knee charley horses.
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| 54 | 2021-01-11 | nausea |
Approximately 2 hours after the vaccine, I had flushing feeling, no elevated temperature. Arm soren...
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Approximately 2 hours after the vaccine, I had flushing feeling, no elevated temperature. Arm soreness, nausea. I also checked my b/p. It was more elevated than usual. (130/90?s). These symptoms subsided 24-48 hours after the vaccine.
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| 54 | 2021-01-11 | nausea | Fever, body aches, extreme chills, nausea, fatigue. >16 hrs |
| 54 | 2021-01-11 | nausea |
Overnight early am 7th woke up to shaking chills fever >101, muscles, joints aches, headache, nause...
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Overnight early am 7th woke up to shaking chills fever >101, muscles, joints aches, headache, nausea sinus congestion Treated fevers for 3 days. Felt horrible missed 3 days wrk and call due to symptoms. Tested for COVID-19 was negative on01- 11-21 FLU test done also NEG..01-11-21
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| 54 | 2021-01-11 | abdominal distension, diarrhea, nausea, abdominal pain upper, abdominal discomfort |
Stomach cramps, bowel cramps, malaise, bloating, loose stools, night sweats, nausea, headache, dizzi...
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Stomach cramps, bowel cramps, malaise, bloating, loose stools, night sweats, nausea, headache, dizziness, joint pain
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| 54 | 2021-01-11 | nausea |
Within 12 hrs of first dose of Pfizer Covid vaccine, patient experienced tiredness. Within 36hrs pat...
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Within 12 hrs of first dose of Pfizer Covid vaccine, patient experienced tiredness. Within 36hrs patient experienced nausea, severe headache, and dizziness. Patient reports after these symptoms she had to stay in bed for the next day but by day 4 she was significantly improved and just tiredness occurred over the weekend. 6 days total.
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| 54 | 2021-01-11 | diarrhea, nausea |
chills; fever, up to 100.9; muscle aches; headache; nausea; diarrhea; This is a spontaneous report f...
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chills; fever, up to 100.9; muscle aches; headache; nausea; diarrhea; This is a spontaneous report from a contactable other HCP (patient). This 54-year-old female reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date were not reported) on 03Jan2021 11:00 (at the age of 54-years) as single dose, Intramuscular left arm for COVID-19 immunisation. Medical history included no allergies to medications, food, or other products and asthma. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications include DOXYCYCLINE (DOXYCYCLINE), METRONIDAZOLE (METRONIDAZOLE), minerals nos, vitamins nos (ONE A DAY) and CALCIUM CARBONATE (CALTRATE). Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 03Jan2021 at 03:30 AM the patient experienced fever, up to 100.9, muscle aches, headache, nausea, diarrhea, chills. Events lasted about 24 hours. The patient did not received treatment as a result of the events. Lab data included body temperature up to 100.9 on 03Jan2021. The outcome of event chills was recovered, fever, up to 100.9 was recovered, muscle aches was recovered, headache was recovered, nausea was recovered and diarrhea was recovered all on Jan2021. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
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| 54 | 2021-01-11 | nausea, vomiting |
severe dizziness; nausea; vomiting; headache; Vertigo type symptoms; This is a spontaneous report fr...
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severe dizziness; nausea; vomiting; headache; Vertigo type symptoms; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELU140), via an unspecified route of administration on 21Dec2020 11:00 in right arm at single dose for COVID-19 immunization. Medical history included vertigo from 2015 to an unknown date. There were no concomitant medications. On 29Dec2020 19:00, one week after vaccination, the patient experienced severe dizziness, nausea, vomiting and headache that continues and seemed to be severe vertigo type symptoms. No treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in a Public Health Clinic/Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 54 | 2021-01-12 | nausea, abdominal discomfort |
14 hours after vaccination, woke up to slight body aches so went to take Tylenol and sudden wave of ...
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14 hours after vaccination, woke up to slight body aches so went to take Tylenol and sudden wave of nausea hit and passed out falling on floor. Had slight stomach upset and significant chills. Took Tylenol and was recovered by 8 a.m.
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| 54 | 2021-01-12 | vomiting, nausea | NAUSEA AND VOMITING, WEAKNESS AND DIZZINESS, FATIGUE, SORE MUSCLES |
| 54 | 2021-01-13 | abdominal discomfort, nausea |
1/13/20:05:30 awoke with rt arm tenderness/pain at site of injection - has continued to time of this...
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1/13/20:05:30 awoke with rt arm tenderness/pain at site of injection - has continued to time of this document 1/14/21 08:00 07:30 increased dry cough, scratchy throat 08:30 sore throat 09:30 mild headache and muscle aches, sore throat, cough when talking 10:30 increasing muscle aches and headache, laryngitis, cough resolving, mild intestinal discomfort 11:00 left work 11:30 all symptoms at 10:30 continuing, increasing fatigue; took 1000mg acetominophen slept most of the time noon - 4 pm 4pm cough resolved, muscle aches continued, headache improved, laryngitis continued. mild fatigue 6:00 pm noted loss of smell (could not smell cooked garlic - my husband could) Laryngitis & muscle aches continued throughout evening 7:30 pm 2nd dose 1000mg acetaminophen 1/14/20 - 06:00 am laryngitis resolved Ongoing scratchy throat, mild muscle aches, mild nausea/intestinal discomfort. Laryngitis and cough mostly resolved - but i am not talking much; speech is an irritating factor for both symptoms. Fatigue improved. Headache mostly resolved. Took 1000 mg acetaminophen.
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| 54 | 2021-01-13 | nausea |
48 hours of fever up to 102 degrees. Severe headache, fatigue and bodyaches. Nausea and severe arm...
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48 hours of fever up to 102 degrees. Severe headache, fatigue and bodyaches. Nausea and severe arm pain radiating to neck. Took tylenol and tramadol for 36 hours and then symptoms began to subside. By the third day post vaccine, all symptoms except for fatigue resolved.
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| 54 | 2021-01-13 | nausea |
Developed sweating and chills with headache around 3:00 am. Got up at my usual time 5:30 am to use t...
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Developed sweating and chills with headache around 3:00 am. Got up at my usual time 5:30 am to use the bathroom and get dressed but felt nauseous with headache. Went to wash my hands and then walked back to bedroom but had syncopal episode along the way lacerating my lower lip and injuring my knees. Still unable to extend knee due to injury with pain and swelling
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| 54 | 2021-01-13 | nausea |
Fever of 101 degrees, severe headache, fatigue and bodyaches. Chills and nausea. Severe right arm ...
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Fever of 101 degrees, severe headache, fatigue and bodyaches. Chills and nausea. Severe right arm pain. Took tylenol and tramadol for pain and fever.
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| 54 | 2021-01-13 | nausea |
She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; s...
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She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; shake/her hands were shaking so hard; they took her temperature and it was 100/her fever went to 101/temperature had gone to 102.6; heart rate was elevated at 100/heart rate was 110/heart rate went to the high 120s; headache; backache; nauseated; chest was hurting; The initial case was missing the following minimum criteria: Invalid for unspecified adverse event. Upon receipt of follow-up information on 08Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration in deltoid left on 29Dec2020 07:30 at single dose for COVID-19 immunisation. Medical history included ongoing sleep apnoea (diagnosed about 3-4 years ago, wear her CPAP religiously), Hashimoto's hypothyroid, and chronic low vitamin d (lack of sunlight). Concomitant medication included levothyroxine sodium (SYNTHROID) from 2016 and ongoing for Hashimoto's hypothyroid, ergocalciferol (VIT D) from 2018 for chronic low vitamin d; lack of sunlight (She did not take it religiously, but was supposed to take it everyday). At 10:30 AM (29Dec2020), she started to get cold and shake. She thought that this was insane and it was in her head. It became so severe she could not use her computer her hands were shaking so hard. She went back up to where they were giving vaccines, they took her temperature and it was 100. It had been normal the morning before she got the vaccine. Her heart rate was elevated at 100. They put a blanket on her and said they wanted to watch her for 15 minutes. In that time her fever went to 101 and her heart rate was 110. They took her to the ER. She was there for 5 hours. Her heart rate went to the high 120s. They did a 12 lead EKG. Her temperature had gone to 102.6, which was the highest. They gave her a liter of Normal Saline. She also had a headache, backache, and felt nauseated. The liter of fluid helped, no doubt. She was not admitted. She was wiped out the next day (30Dec2020) with aches and pains still. Their concern was they said they did not give her epinephrine because her heart was too high. She had no breathing issues. Just extreme cold. At one point she had woke up in the ER (29 or 30Dec2020) and her chest was hurting, she knows from her heart rate being too fast. She was so cold. She had on 6 blankets. The next day (30Dec2020) she still had the aches and pains, she was tired, and had brain fog. It all went away on 30Dec2020. She had nothing after that. What scared her was the heart rhythm. The ER doctor says its not great, but felt that getting the second dose was better than her having COVID. The Electrophysiologist she saw, said she was unsure if she should get the second dose. The hospital said that for this next dose, they would give her the injection, wait 15 minutes, then send her home, expecting that she would have the same thing happen. When after the first dose, she was in the ER on a 12 lead EKG with an intravenous (IV). She had no arm pain the whole time. The reporter assessed all events related. She felt fine prior, walking in to get the vaccine. But she was much better the next day and recovered completely. She was just worried about the second dose. The outcome of events was recovered on 30Dec2020.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-13 | diarrhea, nausea, vomiting |
Started getting dizzy on my way home from work around 6pm, when I got home I was feeling nauseous. W...
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Started getting dizzy on my way home from work around 6pm, when I got home I was feeling nauseous. Went to the bathroom and had diarrhea and then began to vomit. My temp spikes to 102.6. Had a restless night but by the next evening I was fine, no issues or fever.
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| 54 | 2021-01-13 | diarrhea, abdominal pain |
The first day I had a weird headache . Three days later I felt like I could go into chills and had l...
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The first day I had a weird headache . Three days later I felt like I could go into chills and had low grade fever of 99.6/99.7, feeling like I didn't feel right. I had terrible cramping in my abdomen and had diarrhea twice . My employer sent me to the ER to test for Covid, Flu, RSV. By the 22nd I was feeling fine about 5-6 days later.
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| 54 | 2021-01-14 | nausea |
1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SV...
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1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SVT with first dose of some new medications. Pt reports intermittent SVT and PVCs post ablasion. HR 136, regular rhythm. 1828: 176/101 (119), HR 108, Resp 22, 99% on room air Pt reports feeling like her HR is returning back to normal, hand tremors continue. Reports mild shortness of breath, which is typical with her SVT episodes. 1831: 151/82 (98), HR 81, regular rhythm, Resp 12, 98% on room air. Denies any worsening or any additional symptoms. Hand tremor no longer present. 1839: 151/104 (113), HR 76, regular rhythm, Resp 10, 98% on room air. Pt reports headache and mild nausea that is typical with her SVT episodes. Pt appears relaxed sitting in chair. 1845: HR 78, regular rhythm. Pt remaining in monitoring area for 15 additional minutes. No s/s further distress. Pt calling husband to take her home. 1905: BP 157/91 (107), HR 87, regular rhythm, 98% on room air, Resp 14 Pt c/o numbness to L arm with some L chest tightness. Reports this sometimes happens with her SVT episodes. 1907: No further chest tightness or L arm numbness. Pt reports feeling anxious. Does not want to go to the ED for further monitoring. Continues to report that her symptoms feel typical after her SVT episodes with some additional nausea. 1910: 132/112 (117), HR 78, regular rhythm. Pt reports improvement of symptoms. Pt relaxed in chair. Instructed pt to stop and call 911 if she has any concerning symptoms after leaving clinic including difficulty breathing or HR abnormalities.
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| 54 | 2021-01-14 | nausea | Fever 100.4, headache, nausea, body aches, right arm soreness |
| 54 | 2021-01-14 | nausea |
Fever 101.5. Body aches, chills, severe headache and eye pain, foggy head and forgetfulness, nausea....
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Fever 101.5. Body aches, chills, severe headache and eye pain, foggy head and forgetfulness, nausea. This started 8 hours after injection and lasted for 24 hours. Extreme exhaustion followed the next 24 hours. Severely blood shot eyes developed during first 24 hours and remains still after 78 hours. Still having brain fog after 78 hours.
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| 54 | 2021-01-14 | diarrhea | Fever 101f Diarrhea Aches and pains Headache |
| 54 | 2021-01-14 | nausea |
I waited for 30 minutes; I walked to my car and didn't feel well; I thought maybe I was hungry I ate...
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I waited for 30 minutes; I walked to my car and didn't feel well; I thought maybe I was hungry I ate 1/2 banana and drank some water. I started to drive home. It felt like a huge cold railroad spike was being driven up the top of my shoulder to my neck, it was a cold sensation anteriorly and posteriorly on my neck. Then my face (left side) started to go numb, it started just about the top of my left ear and went all the way to my lips. It stopped midline. It felt like a dental block. I could still swallow and breathe. I started shaking, felt nausea, my upper esophageal sphincter started to spasm. I kept checking my tongue and airway to see if I should pull over and call 911. I drove to the ER. My left side of face was numb, I was trembling, tremoring. They gave me small dose of IV Bendadryl (12.5 mg) and Pepcid, I slowly started to feel better and the feeling came back to my face moving from midline lip to cheek. It still felt "funny" but much better. I was in the ER for around 2 hours. I have had more tremoring since my vaccine in my neck and hand (I do have primary essential tremors but it is tremoring much more now) and more neck pain (could be due to the increased tremors)
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| 54 | 2021-01-14 | nausea |
Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose...
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Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose was 89 in the morning. by 1400 hours my glucose was 250. By bed time it was 300. I did not eat dinner and adjusted my insulin and took an extra 500mg metformin. I had chills and fever through the night and all the next day. Fever 99 to 101. Tylenol and showers used to control fever. I was very sleepy all that day. I was sleepy with the first shot also. I woke up on Jan. 6, 2021 with a hemorrhage in my right eye. I called the retinol specialist and was given a shot of Eylea in my right eye Jan. 7, 2021., He asked that I report this advers reaction.
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| 54 | 2021-01-14 | nausea |
Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, head...
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Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Nauseous with injection.; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19), intramuscular at left arm on 08Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included migraine and No known allergies. Concomitant medication included sumatriptan succinate (IMITREX), fluoxetine hydrochloride (PROZAC). The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization at right arm on an unknown date. The patient experienced nauseous with injection on 08Jan2021. Next day (09Jan2021), she had sore arm, neck, body, headache, tired chills, afebrile. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. Information about lot and batch number was requested.
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| 54 | 2021-01-14 | nausea, decreased appetite |
Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hour...
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Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hours. Mysugar climbed to 250 by dinner time. By bed tme my sugar was 300. I did not eat dinner. I had no appectite. I increased my insulin and metformin dose. I had chills and fevery thru the night and the next day. High fever 101. I treated this with tylenol and showers. I was really sleepy all day. I had little to eat and still my sugar was 300 most of the day. on Jan 6. I woke up and had a hemmorrhage in my right eye. I called my retinol specialist and and received an injection of Eylea on Jan 7, 2021
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| 54 | 2021-01-15 | nausea | Fever Body aches Headache Nausea |
| 54 | 2021-01-15 | diarrhea |
No treatment from medical professional. I took Tylenol and drank water. I had the vaccine at 10 am....
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No treatment from medical professional. I took Tylenol and drank water. I had the vaccine at 10 am. I felt perfect as I did with the first vaccine until I woke at midnight with a high fever , diarrhea, severe fatigue and muscle aches. Hard for me to move or walk. Needed assistance from husband to get to the bathroom. The symptoms lasted until approximately 9 am. Then I felt tired but fine. Today I feel tired but no symptoms. Back to normal.
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| 54 | 2021-01-17 | nausea, decreased appetite |
I woke up and had a horrible headache. I went to the bathroom to take a Maxalt then went back to bed...
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I woke up and had a horrible headache. I went to the bathroom to take a Maxalt then went back to bed. I woke up again at 6:30 with the same horrible headache not relieved at all by Maxalt so I took another dose. I had vertigo so I went back to bed. I woke up at 8:00 still with the horrible headache and vertigo but had horribe nausea. I never vomited. I felt weak all day, had no appetite and my neck felt very stiff all day. In the evening my knees were aching. The next day I continued to have a mild headache and neck stiffness.
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| 54 | 2021-01-17 | nausea | Nausea, head ache, body aches chills |
| 54 | 2021-01-18 | nausea |
Injection site swelling and redness; Injection site swelling and redness; Low grade fever; Nausea; T...
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Injection site swelling and redness; Injection site swelling and redness; Low grade fever; Nausea; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient received bnt162b2 (BNT162B2) (Lot# EJ1686, Exp date 31Mar2021), via an unspecified route of administration, on 05Jan2021, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced injection site swelling and redness, low grade fever and nausea all on 06Jan2021 with outcome of unknown. Therapeutic measures were taken as result of the events and included treatment with a 1000 mg Tylenol. The events were considered related (source of assessment: primary source reporter, method of assessment: global introspection).
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| 54 | 2021-01-18 | vomiting | Vomiting x 4, fever, chills, body aches, headache, sweating |
| 54 | 2021-01-18 | nausea |
chills for about 2/12 hours, fever until 1/16. headache, muscle aches, nausea evening on 1/16 with ...
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chills for about 2/12 hours, fever until 1/16. headache, muscle aches, nausea evening on 1/16 with headache mild shooting pain headache on and off through 1/17; treated with tylenol
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| 54 | 2021-01-18 | nausea |
severe headaches; night sweats; severe bone crunching chills; light headedness/feeling faint; fever;...
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severe headaches; night sweats; severe bone crunching chills; light headedness/feeling faint; fever; muscle and joint ache/pain; muscle and joint ache/pain; nausea; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of BNT162b2 (lot: EK 9231), via an unspecified route of administration in left arm on 26Dec2020 12:30 at single dose for covid-19 immunization. Medical history included subclinical hypothyroid, Premature ventricular contractions (PVC's), Migraines. Concomitant medication included metoprolol succinate (TOPROL), fesoterodine fumarate (TOVIAZ), levothyroxine, omeprazole, "multi v". The patient experienced severe headaches, night sweats, severe bone crunching chills, light headedness/feeling faint, fever, muscle and joint ache/pain, nausea on 28Dec2020 02:00. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received the urgent care, lab tests for these events. The patient's results of covid tests (Nasal Swab, covid swab) were Negative on 31Dec2020 and 05Jan2021. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
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| 54 | 2021-01-18 | diarrhea |
temp 99.7 with Tylenol on board, diarrhea, chills myalgia lasted 1/14 at 1:30am til morning of 1/15/...
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temp 99.7 with Tylenol on board, diarrhea, chills myalgia lasted 1/14 at 1:30am til morning of 1/15/21
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| 54 | 2021-01-19 | nausea |
2 days after infusion, severe arm pain and fever, body aches, and extreme nausea (unable to eat any...
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2 days after infusion, severe arm pain and fever, body aches, and extreme nausea (unable to eat anything). Started on 1/6 in morning and gone by night of 1/6.
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| 54 | 2021-01-19 | vomiting | HEADACHE,FEELING SICK,PAIN ON SHOULDER,PAIN ALL OVER THE BODY AND TWO EPISODE OF VOMITING. |
| 54 | 2021-01-19 | vomiting |
emesis; sweats; horrible headache; Extremely tired; chills; This is a spontaneous report from a cont...
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emesis; sweats; horrible headache; Extremely tired; chills; This is a spontaneous report from a contactable other health professional. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EL0142) via an unspecified route of administration at left arm on 10Jan2021 at a single dose (dose number: 2) for COVID-19 immunization. Medical history included allergies to cefaclor (CECLOR), azithromycin (ZITHROMAX Z-PACK, reported as z pack), pinapple, coconut. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included warfarin sodium (JANTOVEN), sertiline, metformin (reported as metforman, to be clarified). Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EK5730) intramuscularly at left arm on 20Dec2020 at 09:30 AM at a single dose (dose number: 1) for COVID-19 immunization and reported events included emesis within 40 minutes, upset stomach for 3 hours approx, sweating and headache, lasting about 4 hours. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient was not pregnant at the time of vaccination. After the 2nd shot, it was reported emesis within 40 minutes and lasting all day, extremely tired, horrible headache, sweats and chills. This lasted 36 hours. Start date of adverse event was reported as 10Jan2021 at 10:30 AM. No treatment received for the adverse events. The outcome of events was resolved in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 54 | 2021-01-20 | nausea |
After first shot had palpitations and nausea for 24 hours. ( I did report prior to taking second dos...
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After first shot had palpitations and nausea for 24 hours. ( I did report prior to taking second dose) After second shot developed shortness of breath and nausea. Particularly bad with having to don mask. Did not go to ER or doctor. Has resolved somewhat' but still not able to tolerate mask.
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| 54 | 2021-01-20 | nausea |
Injection site pain, headache, tiredness, muscle pain, chills, nausea, feeling unwell, sweating, diz...
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Injection site pain, headache, tiredness, muscle pain, chills, nausea, feeling unwell, sweating, dizziness. After 45 minutes it subsided enough, except the nausea, so that I could go to the recovery area where I remained for a few more minutes. I then felt well enough to drive myself home.
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| 54 | 2021-01-20 | abdominal distension |
Rash on the inner side of the arms, both left and right (size if a palm) and under the breasts. Stre...
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Rash on the inner side of the arms, both left and right (size if a palm) and under the breasts. Stretch marks-like swelling in the same area. After 30 min the symptoms have disappeared.
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| 54 | 2021-01-20 | vomiting, abdominal discomfort |
emesis; upset stomach; Sweating; headache; This is a spontaneous report from a contactable other hea...
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emesis; upset stomach; Sweating; headache; This is a spontaneous report from a contactable other healthcare professional. A 54-year-old female patient received the first dose of bnt162b2 (COVID-19 vaccine, brand: Pfizer) lot no: EK5730, intramuscular in left arm on 20Dec2020 09:30 at a single dose for Covid-19 immunization in a hospital. Medical history included allergies pineapple and coconut. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medication included warfarin sodium (JANTOVEN), sertraline, and metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cefaclor (CECLOR) and zithromax (Z-PACK) and experienced allergies to both. On 20Dec2020, after the first shot, the patient experienced emesis within 40 minutes. Then on unspecified dates, the patient experienced upset stomach for 3 hours approximately, sweating and headache lasting about 4 hours. Treatment was not given for the events. The patient recovered from the events.
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| 54 | 2021-01-21 | abdominal pain upper |
Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection s...
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Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection site; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKQ231), via an unspecified route of administration at the left arm on 11Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 11Jan2021, patient experienced metallic taste in mouth, which was reported as worsened and sore arm at injection site. On 12Jan2021within about an hour after vaccination, the patient experienced lowgrade fever that was slowly going up, headache, stomach ache, & body ache. The patient has not recovered from the events.; Sender's Comments: Based on the time association, the reported events are possibly related to suspect BNT162B2 administration in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-21 | nausea |
Pt. complained of nausea and mild headache, she appeared to have some mild erythroderma of face and ...
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Pt. complained of nausea and mild headache, she appeared to have some mild erythroderma of face and both arms, but unclear if it was baseline. She seemed anxious about the vaccine, and wanted to leave as her husband was waiting for her.
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| 54 | 2021-01-22 | nausea | Fever, chills, body aches, fatigue, left arm pain, nausea |
| 54 | 2021-01-24 | nausea | Fever, body aches, lump on arm, nausea, headache less than 24 hours, treated with meds |
| 54 | 2021-01-24 | nausea |
On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continu...
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On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continued x 4 days, then, local tenderness persisted for additional week. Onset of HA 1/18/21 through 1/25/21 for 6 of the 7 days, for a few hours duration and relieved with Aleve qd to BID. On 1/22/21 noticed Left shoulder muscle weakness, visible atrophy of muscle and dull pain in shoulder/arm and neck. clicking in the joint with rotation movement. spoke with Director of Rehab and advised to contact and seek medical care. Call placed to PCP 1/23/21 with office closed for the weekend. due to non-urgent symptoms, opted to wait for appointment on Monday. Continued pain and symptoms through the weekend with feeling of instability in the shoulder. spoke to company for Q/A on 1/24/21 and sought medical attention with appointment for care on 1/25/21.
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| 54 | 2021-01-24 | nausea |
On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continu...
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On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continued x 4 days, then, local tenderness persisted for additional week. Onset of HA 1/18/21 through 1/25/21 for 6 of the 7 days, for a few hours duration and relieved with Aleve qd to BID. On 1/22/21 noticed Left shoulder muscle weakness, visible atrophy of muscle and dull pain in shoulder/ arm and neck. Clicking in the joint with rotation movement. Spoke to Director of Rehab and advised to contact CDC and seek medical care. Call placed to PCP 1/23/21 with office closed for weekend. Due to non-urgent symptoms, opted to wait for appointment on Monday. Continued pain and symptoms through the weekend with feeling of instability in the shoulder. Spoke to CDC for Q/A on 1/24/21 and sought medical attention with appointment for care on 1/25/21.
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| 54 | 2021-01-25 | nausea | Felt flushed and nauseated |
| 54 | 2021-01-25 | nausea | Fever, chills, terrible body aches, unrelenting headache, nausea for 14 hours |
| 54 | 2021-01-25 | abdominal discomfort |
I felt good all day till about 130am then I started feeling very uncomfortable. I had positive Covid...
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I felt good all day till about 130am then I started feeling very uncomfortable. I had positive Covid-19 and I was having some of those symptoms- very painful headache, terrible lower back pain , very tired, upset stomach and sore at injection site. I couldn't get comfortable . I started taking 3 Tylenol ES, Ibuprofen 800mg, and Pepto Bismol at same time every 4 hours. After about 18 hours I started feeling normal. The testing site told me some people are having reactions.
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| 54 | 2021-01-25 | vomiting, nausea | Individual experienced nausea and vomiting. |
| 54 | 2021-01-26 | nausea | NAUSEA, DIARRHEA, HA |
| 54 | 2021-01-27 | nausea |
Dizziness; Severe migraine; Nausea; Blurred vision; This is a spontaneous report from a contactable ...
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Dizziness; Severe migraine; Nausea; Blurred vision; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL3246, expiry: unknown), via an unspecified route of administration in the left arm on 12Jan2021 at a single dose in the workplace clinic for COVID-19 immunization. Medical history included lupus SLE and known allergies with Stadyl. Concomitant medications included ascorbic acid (ESTER-C [ASCORBIC ACID]) and prednisone. The patient had no other vaccine in four weeks. The patient experienced severe migraine, blurred vision, dizziness and nausea on 12Jan2021 at 14:00. The patient was tested for Covid prior to vaccination but was not tested post vaccination. The events were not treated. The outcome of the events was recovering.
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| 54 | 2021-01-27 | nausea | fatigue nausea headache pruritis |
| 54 | 2021-01-28 | nausea |
About 15 minutes after vaccination she reported feeling light headed and nauseous like the start of ...
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About 15 minutes after vaccination she reported feeling light headed and nauseous like the start of a panic attack. She tried to walk outside for fresh air, but had to sit down after about 20 feet of walking. She reported more nausea, feeling very hot, and had a hard time communicating. She was given a cool washcloth and fanned while being held up by a support person. Her blood pressure was initially high, and rose significantly over a period of about 5 minutes. Blood sugar was checked and was 475 mg/dL. 911 was called, and after about 10 minutes of supportive care paramedics transported her to the hospital. She was fairly limp at time of transport and had a hard time standing. The facility staff updated me several hours later that they had heard that she was doing well. It appeared to be a panic attack.
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| 54 | 2021-01-28 | diarrhea |
After receiving the second dose about 1PM I already had 100.2F temp and I had headache, fever, body ...
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After receiving the second dose about 1PM I already had 100.2F temp and I had headache, fever, body aches like I was hit by a truck, exhausted and tired, I also had some diarrhea and my husband even had to help me a couple of times to get off of bed. I went home and took some Motrin and slept if and when I woke up I told my husband it felt like I was hit by a truck. I had Covid in June and since then no appetite, no sense of taste and smell and lost 130lbs. I also noticed 2 or 3 days after my shot that my diabetes would shot to 300s and then go down to like 58 without me doing anything different.
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| 54 | 2021-01-28 | vomiting |
Headache; Vomiting; Lower abdominal cramping; she scanned the bar code it said it was her first one ...
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Headache; Vomiting; Lower abdominal cramping; she scanned the bar code it said it was her first one but it really was her second one; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL1284), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. Medical history included systemic lupus, autoimmune disorder. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunization and experienced headache. The patient stated that she had her second vaccine on Monday (11Jan2021) and when she scanned the bar code it said it was her first one but it really was her second one. She was not given the paper too for monitoring what she got at first one but ever since she got her first one she had a constant headache and that continued today and then at the middle of the night for whatever reason she had some vomiting and lower abdominal cramping and so to call out sick to work. She did have autoimmune disease, systemic lupus. She was not currently on any kind of suppressants or anything like that. She was advised to have a Covid test. The only criteria that she need according to her work was having the headache. Was it possible that this was just side effect from the immunization? The patient received Tylenol as treatment for the headache. The outcome of events was unknown.
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| 54 | 2021-01-29 | nausea |
Received 2nd Covid-19 vaccination as a RN at a drive through site. About 4 hours post shot had fever...
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Received 2nd Covid-19 vaccination as a RN at a drive through site. About 4 hours post shot had fever of 101 degrees Fahrenheit. Nausea. Headache. Body/muscle aches. Information posted in my daily cdc email registration text i received. Illness lasted 24 hours and I did miss work due to fever. Medcated with over counter tylenol and benadryl.
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| 54 | 2021-01-30 | nausea, vomiting |
Severe headache (migraine) lasting 16 hours, nausea and vomiting, fever 101 for 6 hours, severe fati...
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Severe headache (migraine) lasting 16 hours, nausea and vomiting, fever 101 for 6 hours, severe fatigue, body aches, injection pain hot and very sore and hard.
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| 54 | 2021-01-31 | decreased appetite, nausea |
Exhaustion/ Felt more exhausted; Lightheadedness/ Light headed; Nausea/ Nauseous; Sore throat/ Throa...
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Exhaustion/ Felt more exhausted; Lightheadedness/ Light headed; Nausea/ Nauseous; Sore throat/ Throat is really sore too/ there is pressure there; Injection site soreness; Loss of appetite; Not feeling well; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL324) via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 in Oct2020 and she had a mild case. The patient had no other medical history. There were no concomitant medications. The patient got the vaccine yesterday (reported as 18Jan2021, clarification pending) at work in the afternoon. Yesterday, she felt fine, except for the normal injection site soreness. Today on 18Jan2021, she felt more exhausted. At work started feeling kind of lightheaded. She was kind of nauseous and stuff. Over all, she was not feeling well. She didn't have a prescribing doctor. She got it done at her place of work. This morning when she woke up she noticed the exhaustion. Being light head started about an hour or half or so, maybe 2 hours ago. The nausea, she first noticed about 1 hour to 2 hours ago. Her throat was really sore too. She first noticed that this morning, and it had persisted. It was like a sore throat but there was pressure there. She took Ibuprofen for the injection site soreness. She had experienced a loss of appetite. She ate this morning and didn't have much to eat. She was also usually hungry by now, and she hadn't ate. All she ate was some protein bar because she was nauseous, but the symptoms hadn't subsided from eating. She got the vaccine because she was an essential worker. She worked with people with disabilities. She was looking at symptoms and figured she should call and see if this throat issue she was having would make it severe. She wasn't having trouble breathing or face swelling or anything. She just couldn't tell if her throat was just sore or swollen too. There was no investigation assessment. The outcome of event normal injection site soreness was recovering, outcome of event not feeling well was unknown, outcome of other events was not recovered.
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| 54 | 2021-01-31 | nausea |
Patient complained of nausea and a "itchy" throat after receiving her 2nd Covid vaccination and decl...
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Patient complained of nausea and a "itchy" throat after receiving her 2nd Covid vaccination and declined an epinephrine injection. She was taken to the Emergency Department via ambulance.
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| 54 | 2021-01-31 | nausea |
Same symptoms as after 1st vaccine. starting about 12 hours post injection I developed chills, feve...
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Same symptoms as after 1st vaccine. starting about 12 hours post injection I developed chills, fever, could not get warm, joint pain-specifically low back, hips, shoulders, achy all over, headache, nausea. Slept poorly. Woke up the next morning with headache, achy. All symptoms passed about 18 hours post vaccine. of note I have never been tested for covid but my husband had a severe case in March. I tested positive for antibodies twice with the most recent time 12/14/20. I have never had symptoms of covid (until I got the vaccine)
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| 54 | 2021-01-31 | nausea |
fever, nausea, rash all over body, painful swollen knees and hands, and shortness of breath. She ha...
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fever, nausea, rash all over body, painful swollen knees and hands, and shortness of breath. She had an eppy-pin she used.
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| 54 | 2021-02-01 | diarrhea |
heart rate 160 (elevated); she had an allergic reaction to the vaccine; fever of 102; chills; irrita...
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heart rate 160 (elevated); she had an allergic reaction to the vaccine; fever of 102; chills; irritation in throat; Diarrhea; felt funny; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (BNT162B2 reported as Pfizer COVID 19 vaccine; lot number: EL3302; expiration date: unknown), via an unspecified route of administration left arm on 15Jan2021 09:30 at a single dose (reported as unknown dosage with a needle to left arm one time) to prevent Covid 19 and build up antibodies to Covid 19 (COVID-19 immunization). The patient has no medical history and concomitant medications. The patient reported that last Friday (15Jan2021) at 9:30 she took the first dose of vaccine and felt funny, so she waited for 15 minutes. She mentioned that she had not eaten before so they gave her glucose tablets. She then mentioned that later on that night (15Jan2021) that she had a fever of 102 [unit unspecified], elevated heart rate of 160 [unit unspecified], had chills and felt like she had Covid. She further stated that she had irritation in her throat that started after the vaccine. She stated that her doctor mentioned that she may be positive for Covid 19 and did not know it before she had the vaccine. The patient mentioned that she had the nasal swab for Covid and they drew her blood on an unspecified date, but all came back negative. She was told that she had an allergic reaction to the vaccine. She added that she had no symptoms prior to the vaccine. The patient reported that she has to go back for the second Pfizer Covid 19 vaccine on 05Feb2021. The patient received treatment included prednisone, diphenhydramine (BENADRYL) and was given an epinephrine injection (EPIPEN) to bring home. She also was given acetaminophen (TYLENOL) for fever. She was given fluids to try to bring everything down. She added that she was given famotidine (PEPCID) for her stomach due to diarrhea on 15Jan2021 that she is still taking. The outcome of the events allergic reaction and felt funny were unknown, as for diarrhea was not recovered, for the event irritation in throat was recovered on 15Jan2021 while the outcome of the other events was recovered on 17Jan2021.
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| 54 | 2021-02-02 | diarrhea, nausea |
swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrre...
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swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021. Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 54 | 2021-02-03 | nausea |
1) Immediately noticed that I was light-headed or dizzy upon receiving shot. 2) My face started to ...
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1) Immediately noticed that I was light-headed or dizzy upon receiving shot. 2) My face started to feel numb on the left side (below the eye to the jawline and from below my left ear to my nose area. I was worried about a stroke, so I made sure that I was able to smile in my rear-view mirror. The numbness began to clear up around 8 hours later without any muscular drooping of eye or mouth. I still have tingling or a numb feeling in areas but it is not significant at this time. 3) fatigue, slight nausea, pain in right collar bone area has been present since Monday. All seem to be minor side effects.
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| 54 | 2021-02-03 | diarrhea | DEVELOPED SEVERE DIARRHEA |
| 54 | 2021-02-03 | nausea |
Typical headaches; muscle aches; nausea; distorted sense of smell (rancid smell and altered smells) ...
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Typical headaches; muscle aches; nausea; distorted sense of smell (rancid smell and altered smells) and sense of taste severely diminished at 24 hours after initial dose of vaccine.; distorted sense of smell (rancid smell and altered smells) and sense of taste severely diminished at 24 hours after initial dose of vaccine.; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular in the right arm on 22Jan2021 12:15 at single dose for COVID-19 immunisation. Medical history included elevated blood pressure and allergy to raw walnuts and pecans. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included biotin (BIOTIN), vitamin d nos (VITAMIN D NOS), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), fexofenadine, hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ), cetirizine. The patient previously took morphine and experienced drug hypersensitivity. On 23Jan2021 15:00, the patient experienced typical headaches, muscle aches, nausea, distorted sense of smell (rancid smell and altered smells) and sense of taste severely diminished at 24 hours after initial dose of vaccine. No treatment was received for the adverse events. Clinical outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 54 | 2021-02-03 | abdominal discomfort |
approx. 15 minutes after injection c/o chest tightness, slightly lightheaded, HR increase. Vitals: ...
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approx. 15 minutes after injection c/o chest tightness, slightly lightheaded, HR increase. Vitals: 112/78, HR 69, 16 RR,A/0x3, As time progressed c/o achiness when she turns head side to side. 7:12pm c/o head felt foggy, improved chest tightness, heaviness in abdomen, achiness in R) arm pitdenies SOB, BP:110/78, Hr 66, 7:25: felt HR flutter occasionally, heaviness in legs increased and cont. light headed. but ROM WNL, Denies numbness/tingling, denies SOB, no swallowing problems during entire time. Couldn't go back to work and went home with nursing instructions if heaviness were to increase or other symptoms worsen to call 911 or go to ER. Taken home by mother and brother. called next day and symptoms improved.
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| 54 | 2021-02-03 | nausea |
fever/high fever; nausea/urge to throw up; This is a spontaneous report from a Pfizer-sponsored prog...
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fever/high fever; nausea/urge to throw up; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's parent). A 54-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever/high fever and nausea on 16Jan2021, the day after receiving the second dose of the Pfizer-Biontech Covid19 vaccine. The patient had the fever in the morning the next day and the urge to throw up. When the fever went away, she felt nauseous. Outcome of the events was recovered on 16Jan2021. Information on batch/lot number was requested.
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| 54 | 2021-02-04 | nausea |
Patient reports with 1st shot had arm pain described as mild and not interfering with daily activiti...
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Patient reports with 1st shot had arm pain described as mild and not interfering with daily activities. Patient reports with second shot, within 5 hours had arm pain, malaise, headache, and nausea. At 7 hours symptoms increased in severity limiting activity. Also had chills and body aches. Unable to sleep overnight, felt feverish. On day 2 had difficulty working due to migraine headache, unrelieved by migraine medication. On day 3 migraine remained present but was less severe, modifications needed to continue working. On day 4 had worse migraine and nausea, unable to work. Developed itchy blisters, at least 12 to inner thighs, also on belly and back. Took OTC allergy medication, no worsening or additional spread of blisters following this.
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| 54 | 2021-02-04 | nausea |
Spike in BP, feeling of a lump in throat, pt feels hot and nauseous, 50 mg of generic Benadryl orall...
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Spike in BP, feeling of a lump in throat, pt feels hot and nauseous, 50 mg of generic Benadryl orally administered with water, pt went by ambulance to the hospital
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| 54 | 2021-02-04 | nausea |
bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tight...
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bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tightness; numbness on the left side of [her] face, right under the eye; temporary rash she had on the left side of her face, under her cheek; toes crowded back; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose "on the left side" for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She stated feeling nauseous right after the shot and mentioned not eating breakfast. She described having bilateral leg paralysis which she also qualified as locked to the point where she could hardly walk. She added that her leg muscles were so tight that her toes crowded back. She then explained having numbness on the left side of her face, right under the eye and that her jaws felt locked, like a tightness. She specified she didn't know if she really felt tightness in her jaws because of the intensity of her bilateral leg paralysis. She then described a temporary rash she had on the left side of her face, under her cheek. She said her experience occurred two hours post injection on 21Jan2021 and was resolved in Jan2021 after taking a muscle relaxer. She asked if shellfish is in the vaccine. Information about lot/batch number has been requested.
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| 54 | 2021-02-04 | nausea |
felt "winded"/Increasing shortness of breath; nauseous; This is a spontaneous report from a contacta...
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felt "winded"/Increasing shortness of breath; nauseous; This is a spontaneous report from a contactable nurse (patient). This 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3248) via an unspecified route of administration in the left arm on 19Jan2021 at 12:30 at the age of 54-year-old at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included hypertension and obesity. Concomitant medication included vitamin C. The patient had a past drug history of allergy with hydromorphone hydrochloride (DILAUDID); she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231) on 29Dec2020 at 08:30 in the left arm and she experienced nausea and palpitations. On 20Jan2021 at 19:00, the patient felt "winded" and nauseous with increasing shortness of breath, particularly with having to apply mask. The patient did not receive corrective treatments. The patient did not have COVID-19 prior to vaccination, and she had not been tested for COVID-19 post vaccination. She was recovering from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021057652 Same patient, same drug, different dose/event
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| 54 | 2021-02-04 | nausea |
palpitations; nauseous; This is a spontaneous report from a contactable nurse (patient). A 54-year-o...
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palpitations; nauseous; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 29Dec2020 08:30 at a single dose on left arm for COVID-19 immunization. Medical history included hypertension and obesity. The patient's concomitant medications were not reported. The patient previously took Dilaudid and experienced allergies. With first shot-immediately after (on 29Dec2020) had palpitations. Was nauseous times 24 hours on an unspecified date. The outcome of the events was unknown. The patient was not pregnant. Facility type vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
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| 54 | 2021-02-04 | abdominal pain upper, diarrhea, vomiting |
she was useless; diarrhea; vomiting; low grade fever; sore arm; Stomach cramps; didn't feel good; Th...
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she was useless; diarrhea; vomiting; low grade fever; sore arm; Stomach cramps; didn't feel good; This is a spontaneous report from a contactable consumer (patient). The 54-years-old female patient (weight: 150lb-160lb) received first dose of bnt162b2 (BNT162B2, lot number: EL0142), via an unspecified route of administration in left arm on 14Jan2021 15:40 at SINGLE DOSE for covid-19 immunisation. Medical history included none. No Prior Vaccinations (within 4 weeks). Concomitant medication included levothyroxine sodium (SYNTHROID), omeprazole, calcium. On 20Jan2021 weds: "bad diarrhea", vomiting, low grade fever, sore arm (only the day after) and bad stomach cramps. Caller says, "if that's going to happen after 2nd dose- I wont take it". Caller referred to HCP for treatment of post vaccination side effects. She notes that at work on Wednesday she didn't feel good on 20Jan2021 and yesterday she was useless on 21Jan2021. She does feel better today thank goodness. No AE(s) require a visit to Emergency Room or Physician Office. The outcome of the events didn't feel good, she was useless, sore arm was unknown and was recovering for the rest events. No follow-up attempts possible. No further information expected.
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| 54 | 2021-02-05 | nausea |
High heart rate, chills, excruciating headache eyes hurting muscle aches, TMJ joints hurting, dizzy ...
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High heart rate, chills, excruciating headache eyes hurting muscle aches, TMJ joints hurting, dizzy and nauseous
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| 54 | 2021-02-21 | nausea |
Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the he...
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Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the head. Within an hour, I felt exhausted. I went to sleep until about 7pm and when I woke up I felt really nauseous and still very tired. I had a little broth and went back to sleep. on 02/19/2021 at 1am I woke up feeling really hot and had horrible body aches. Even my joints hurt. I took my temperature and it was only 99.2 but my temperature usually runs 97.4 or 97.6. I woke up on 02/20/2021 and my left eye was crusted over just like the first vaccine. My body aches and nausea lasted until 02/20/2021. In the evening of 02/20/2021 I noticed about 10 little red bumps in various places on my body. (2 on left arm, one on back neck in hairline, two on upper back, one on chest, two on left leg, one on lower back and one on left buttock. Today is 02/22/2021 and I am still feeling fatigued. It's not as bad as it was over the weekend but I am still tired. My arm was much sorer with this injection.
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| 54 | 2021-02-21 | nausea, vomiting |
Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one epi...
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Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one episode of emesis. Vital signs at 0830 were bp:184/108, p:112, SpO2:99%. At this time pt was flushed, skin was hot and dry. Vitals at 0835 were bp:179/124, p: 92. Pt began feeling chest pain. Vitals at 0840 were bp: 182-108, p:86. Emergency services were called and pt was transferred to local ED.
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| 54 | 2021-02-21 | nausea |
At 1333 I was called to lobby. Upon arrival, pt states she is feeling light headed and dizzy. VS 108...
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At 1333 I was called to lobby. Upon arrival, pt states she is feeling light headed and dizzy. VS 108/68, 97.6, RR 16, o2 98% on RA, and HR 45. Pt AOx4. Pulses thready. Patient?s skin is moist and clammy. Called for a WC and took pt to exam room where she sat in a reclining chair. VS taken every 5 minutes. She kept mentation through her stay. She states she felt slightly nauseated but was able to hold down water. VS started to improve once she was reclined in exam room. Education provided about f/u with PCP as HR fluctuated between 57-85. Educated about monitoring for symptoms the rest of the day and when to go in for evaluation is symptoms reappear. Pt verbalizes understanding. At 1400, pt states she is feeling better and feels well enough to leave facility. She has no one in town to come get her. VS= 02 98% HR 60, T97.8, BP 120/74, RR 16. Time of leaving, pulses were strong and equal, cap refill WNL. Will call at 1700 for F/U call.
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| 54 | 2021-02-21 | nausea |
This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I s...
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This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I stayed for 45 minutes after my vaccine due to my blood pressure was high. I also felt a little fuzzy. About an hour later I got nauseous, had chills and felt very fatigued. The next morning when I woke up, my left eye was crusted over. I did not think anything of it until I got the second vaccine and it crusted over with it as well. I was very fatigued for 2 1/2 days. Arm was a little sore.
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| 54 | 2021-02-22 | vomiting |
ill-effects started 16 hours after injection; sore arm; brief low-grade fever; vomited; intense mala...
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ill-effects started 16 hours after injection; sore arm; brief low-grade fever; vomited; intense malaise for 24 hours followed by 2.5 days of fatigue
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| 54 | 2021-02-23 | nausea | 2/23 headache, and today nausea with tension headache |
| 54 | 2021-02-23 | nausea |
ABOUT AN HR AFTER RECEIVING MY 2ND DOSE OF THE PFIZER VACCINE I FELT COLD AND A SLIGHT HEADACHE AND ...
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ABOUT AN HR AFTER RECEIVING MY 2ND DOSE OF THE PFIZER VACCINE I FELT COLD AND A SLIGHT HEADACHE AND FATIGUED. LATER THAT EVENING AROUND 7PM THE SYMPTOMS I EXPERIENCED GOT WORSE, POUNDING HEADACHE, AND CHILLS, AND EXTREME MUSCLE ACHE,. INSOMNIA AS WELL. 7AM THE NEXT MORNING CHILLS WERE LESS BUT STILL THERE, BUT THE HEADACHE PERSISTED AND THE NAUSEA GOT WORSE. STILL UNABLE TO SLEEP. AROUND 3PM HEADACHE SLIGHT AND MILD NAUSEA. NO CHILLS. TODAY 2/24/2021 STILL HAVE SLIGHT NAUSEA AND HEADACHE. BUT MUCH BETTER.
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| 54 | 2021-02-24 | nausea |
COVID-19 Vaccine Pt received vaccine 1/7/2021 and discharged to home. Pt endorsed one day of nausea...
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COVID-19 Vaccine Pt received vaccine 1/7/2021 and discharged to home. Pt endorsed one day of nausea, headache, fatigue, and chills following vaccination. On Monday 1/11/21, pt woke up to a large, red, discolored, warm, grapefruit-sized lump on her arm at site of injection. PA at clinic she worked with was curbsided, who said it might be cellulitis. Pt called her PCP who issued prescription for cephalexin 500 mg cap PO TID x 10 days on 1/11/2021. After 2 days of therapy, pt reports lump is still red, discolored, and grapefruit-sized, but is no longer warm. 2/2/21: Pt received 2nd dose of COVID vaccine without issue.
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| 54 | 2021-02-24 | vomiting, diarrhea, nausea |
Progress Notes by Family Medicine Nurse Practitioner COVID VACCINE CLINIC 2/19/2021 Patient is ...
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Progress Notes by Family Medicine Nurse Practitioner COVID VACCINE CLINIC 2/19/2021 Patient is a 54 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience mouth dryness. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH includes seasonal allergies (took zyrtec this am as routinely scheduled), htn, hld. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/19/21 1533 02/19/21 1536 02/19/21 1541 02/19/21 1600 BP: (!) 157/91 (!) 164/91 (!) 158/92 (!) 149/87 BP Location: Right arm Pulse: 88 SpO2: 99% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway/intact. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines and water Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Pt stable and doing well. Pt agreeable to monitor symptoms. Aware of when to seek emergent care. Follow up with pcp otherwise. Pt given ride with one of her co-workers. Pt ambulatory out of the facility. Electronically Signed 2/19/2021 3:41 PM
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| 54 | 2021-02-25 | nausea | Headache, nausea, facial flushing, refused transport by EMS |
| 54 | 2021-02-25 | difficulty swallowing |
Throat felt like it was closing and had difficulty swallowing (that subsided quickly) 45 minutes aft...
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Throat felt like it was closing and had difficulty swallowing (that subsided quickly) 45 minutes after the shot, the right side of my face felt numb and tingly (Felt like when novocaine is wearing off.) Continued for 48 hours and worsened with slight drooping when smiling. Clearing my throat a lot and my right eye keeps tearing up. The doctor confirmed it was "Bell's Palsy" this morning and I have been put on Prednisone.
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| 54 | 2021-02-27 | abdominal pain upper, diarrhea |
I woke up with stomach cramps and diarrhea, an hour later started with chills, low grade fever 100....
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I woke up with stomach cramps and diarrhea, an hour later started with chills, low grade fever 100.3, aches, pains, all over, exhausted . Diarrhea continued for 12 hours, Fever returned at 3:30 pm 100.4, feeling better but still achy.
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| 54 | 2021-02-28 | nausea |
Soreness in arm, inability to lift above head; Soreness in arm, inability to lift above head; fatigu...
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Soreness in arm, inability to lift above head; Soreness in arm, inability to lift above head; fatigue; minor nausea; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318 and expiration date unknown), via an unspecified route of administration on the right arm on 27Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included COVID-19; prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included Vitamin D NOS and Multi-Vitamin. The patient previously took injectable Iodine and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced soreness in arm - inability to lift above head, fatigue and minor nausea on 27Jan2021 at 13:00 (01:00 PM). No treatment was administered for the events. Since the vaccination, the patient has not been tested for COVID-19. The events were resolving.
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| 54 | 2021-02-28 | abdominal pain upper, abdominal discomfort |
Woke up twice not really feeling right. Restless sleep and woke up the second time with stomach ups...
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Woke up twice not really feeling right. Restless sleep and woke up the second time with stomach upset as if going to have diarrhea. minor lower stomach cramping. Did have a bowel movement within 2 hours that was soft with lower abdominal discomfort but wasn't diarhhea. Felt as if a headache was starting
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| 54 | 2021-03-02 | nausea |
Uncontrollable chills; stabbing pain all over; headaches; body shakes; nausea; sensitivity to smells...
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Uncontrollable chills; stabbing pain all over; headaches; body shakes; nausea; sensitivity to smells; motion; tired; This is a spontaneous report from a contactable healthcare professional. A 54-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: T23248), intramuscular in the left arm on 29Jan2021 at 10:00 AM as a single dose for COVID-19 immunization. Medical history included known allergies to sulfa. The patient did not have COVID prior to vaccination, had no other vaccine in four weeks and was not pregnant at the time of vaccination. Concomitant medications included multivitamins, ibuprofen, and paracetamol (TYLENOL). The patient received the first dose of BNT162B2 on 10Jan2021. On 29Jan2021 at 07:00 PM, the patient experienced uncontrollable chills, stabbing pain all over, headaches, body shakes, nausea, sensitivity to smells, "motion", and tired. The patient was not COVID tested after vaccination. The patient received no treatment for the events. Outcome of the events was recovering.
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| 54 | 2021-03-02 | abdominal pain, vomiting |
pt stated stated she woke up vomiting the next morning after receiving the vax. She also has develo...
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pt stated stated she woke up vomiting the next morning after receiving the vax. She also has developed flu like symptoms. Body aches, headache, chest pain, chills, abdominal cramps and diarrhea. Pt states she has not contacted her PCP at this time.
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| 54 | 2021-03-03 | nausea | Pt complains of dizziness, HA and Nausea |
| 54 | 2021-03-03 | nausea | lips numb, chest pressure, flushing, nausea. Evaluated by EMS-Cleared |
| 54 | 2021-03-04 | nausea, abdominal pain upper | Nausea, weakness, fever, bad stomach pain, sore arm, dizziness |
| 54 | 2021-03-04 | difficulty swallowing |
Patient received first dose Pfizer vaccine at 2:13pm and began having difficulty swallowing around 2...
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Patient received first dose Pfizer vaccine at 2:13pm and began having difficulty swallowing around 2:25pm. Oxygen 100% on room air., Heart Rate 111, Blood Pressure 136/84, Respirations 20, Epi pen administered at 2:32pm in right thigh. At 2:45pm telemetry place and was found in sinus rhythm. No chest pain, palpitations, pressure, shortness of breath noted. Patient continues to report difficulty swallowing. IV placed by EMS at 14:51 .20 right arm. 10mg Dexamethasone given via intravenous. Also 50mg Diphenhydramine given intravenous. Pt transfered to Hospital via ambulance.
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| 54 | 2021-03-07 | nausea |
Nausea; sore arm; fever; This is a spontaneous report from a contactable healthcare professional. A...
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Nausea; sore arm; fever; This is a spontaneous report from a contactable healthcare professional. A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3246), via an unspecified route of administration on the right arm on 02Feb2021 08:15 at single dose for COVID-19 immunisation. Medical history allergies: pcn, latex, wheat/gluten, dairy, soy, corn. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (lot number: EL 3246) on 11Jan2021 06:30 PM on the right arm for covid-19 immunisation; epinephrine and experienced allergies. At 6:00 PM on 02Feb2021, patient developed fever 99.4 and steadily rose to 101.5 by 9:30 PM; sore arm all day and night, following day much less sore and easier to move. Fever stayed overnight, down to 100.5 morning on 03Feb2021. Nausea accompanied fever and still have slight nausea. The patient received no treatment. The outcome of the events was recovering.
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| 54 | 2021-03-09 | abdominal discomfort |
sore arm; slept for 17 straight hours; chills; upset stomach; upper body flushing for up to 4 days l...
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sore arm; slept for 17 straight hours; chills; upset stomach; upper body flushing for up to 4 days later; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included Known allergies to Possible latex, Diabetes, sleep apnea, PTSD (Post-traumatic stress disorder)/anxiety, herpes, vitamin d deficiency, environmental allergies, asthma. Concomitant medication was unspecified medication in two weeks. On 16Jan2021 08:00, The patient experienced sore arm, slept for 17 straight hours, chills, upset stomach, upper body flushing for up to 4 days later. Treatment received for the events included OTC medications. The patient was not pregnant. She had no COVID tested post vaccination. There was no other vaccine received in four weeks. The outcome of the events was recovered in 2021. information on the lot/batch number has been requested.
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| 54 | 2021-03-20 | nausea |
I had the vaccine on Wednesday and Friday morning i woke up with a headache; feeling hot and clamy; ...
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I had the vaccine on Wednesday and Friday morning i woke up with a headache; feeling hot and clamy; feeling hot and clamy; nausios; i could not breathe; It was like a really bad asthma attack; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EN6208), via an unspecified route of administration i as single dose in arm left on 10Mar2021 for COVID-19 immunisation. Medical history included known allergy to penicillin. The patient's concomitant medications were not reported. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 04:30 morning the patient experienced woke up with a headache, feeling hot and clamy, nausios. She took Iboprofin and was fine. On 12Mar2021 night she went to bed about 10 pm and woke up from a sound sleep about 12:30 am she could not breathe. It was like a really bad asthma attack which she have never had like that. It took a while to try to breath thru her nose but finally she was able to and took a nebulizer treatment with Abutero. She was very scary. She was wondering if she should take the 2nd dose. The events were considered life threatening. Therapeutic measures were taken as a result of events. Covid was not tested post vaccination. The outcome of events was not recovered.
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| 54 | 2021-03-22 | nausea, vomiting |
Sunday 3/7 at 4 pm began extreme fatigue, nausea & headache. Did not work on 3/8 due to continued na...
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Sunday 3/7 at 4 pm began extreme fatigue, nausea & headache. Did not work on 3/8 due to continued nausea & migraine. Tuesday 3/9 went to ER with same symptoms. Was admitted to hospital on 3/9 with acute kidney injury, nausea & Migraine. Was discharged from hospital on 3/14. Followe up with primary doctor on 3/17. Primary DR requested more bloodwork. Had low potassium. Ended up back in ER 3/17 with nausea and vomiting. They pushed more fluids and sent me home. Will have follow up blood work on 3/26 and next Dr appointment on 4/19. Returned to work for 1/2 day on 3/22. Absent 3/23 for extreme fatigue.
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| 54 | 2021-03-24 | vomiting, abdominal discomfort |
The day after my second dose of the Pfizer vaccine, I experienced chills, severe body aches, stomac...
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The day after my second dose of the Pfizer vaccine, I experienced chills, severe body aches, stomach upset, vomiting. I had loss of sensitivity in my right thigh area that comes and goes. I also have brain fog, joint aches that overwhelming. Subsequently, I had Covid tests through my PCP which were negative but I had symptoms that mimicked Covid symptoms. My PCP recommended I go to the ER and I was admitted for two and a half days. They monitored my heart, did lab work, liver test. I continue with headaches that are more profound. I still have loss of strength in my right thigh, which is intermittent, comes and goes. I still have itchiness on my right thigh and leg with loss of sensation lasting from three to five hours. I will be seeing a neurologist next month.
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| 54 | 2021-03-24 | nausea |
delirous as if I was hungover; delirous as if I was hungover; felt on the brink of fainting; chills;...
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delirous as if I was hungover; delirous as if I was hungover; felt on the brink of fainting; chills; joint pain; pain at the injection site; lethargic; dry cough; severely nauseous; could not eat; serious fogginess; General malaise; fatigued; a debilitating headache; did not feel comfortable driving; weak; hurt in my chest; slept the whole day; This is a spontaneous report from a contactable consumer. A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 13:30 (Batch/Lot Number: EN6202) at 54-years-old as a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccine within four weeks of the suspect vaccine. Medical history included hypertension, and acne from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications included hydrochlorothiazide, olmesartan medoxomil (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; isotretinoin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient previously took (ceftriaxone sodium) ANCEF, start and stop date were not reported, and experienced drug allergy. On 06Mar2021 at 04:00 (as reported), the patient experienced: delirious as if i was hungover (medically significant), felt on the brink of fainting (non-serious), chills (non-serious), joint pain (non-serious), pain at the injection site (non-serious), lethargic (non-serious), dry cough (non-serious), severely nauseous (non-serious), could not eat (non-serious), serious fogginess (non-serious), general malaise (non-serious), fatigued (non-serious), a debilitating headache (non-serious), did not feel comfortable driving (non-serious), weak (non-serious), hurt in my chest (non-serious), slept the whole day (non-serious); with no treatment received. The clinical course was reported as follows: The patient reported that on the first night (as reported) she had chills, joint pain and pain at the injection site. The next day (as reported) she was lethargic and was severely nauseous to the extent she could not eat. The patient also experienced serious fogginess, felt delirious as if she was hungover. The patient felt general malaise and a debilitating headache all day. The patient was fatigued to the extent she did not feel comfortable driving. The patient was so weak, that she felt on the brink of fainting. That evening, the patient slept the whole night through, except when she would awake with a dry cough that hurt in her chest. This cough was not as persistent and intense but was lasting even now. The patient slept the whole day and was just now beginning to feel as if she had recuperated from the vaccine four days later. The clinical outcome of the events was recovered with sequelae on an unspecified date (also reported as "recovered with lasting effects"). The patient was not tested for COVID post vaccination.
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| 54 | 2021-03-25 | nausea |
Dystonia of right foot/dystonia of neck wryneck; left foot and groin flare of patient dermatomyositi...
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Dystonia of right foot/dystonia of neck wryneck; left foot and groin flare of patient dermatomyositis; Nausea; wryneck; flare of the complex regional pain syndrome condition in left arm, left foot & groin flare of dermatomyositis; weakened muscles; Hives on face and neck; intercostal pain; Sternum pain; flare of the patient crps complex regional pain syndrome condition in left arm, left foot; This is a spontaneous report from a contactable Other HCP (patient). A 54-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; E19266), via intramuscularly on 20Feb2021 at 11:30 (at the age of 54-year-old) as a single dose in left arm for COVID-19 immunisation. The patient medical history included Sjogren's, dermatomyositis, crps complex regional pain syndrome, known allergies (unspecified). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication included thyroid (ARMOUR THYROID), pancrelipase (ZENPEP), cynara cardunculus (ARTICHOKE), oenothera biennis oil (PRIMROSE OIL), calendula officinalis, carotenoids nos, crocus sativus, phospholipids, ribes nigrum (MACUGUARD OCULAR SUPPORT), cyanocobalamin (VIT 12), iron, folic acid (FOLATE), retinol acetate (VITAMIN A), ergocalciferol (VITAMIN D), calcium, magnesium and zinc. On 20Feb2021, at 23.30 the patient experienced nausea upon Injection for about an hour and dystonia of neck wryneck and it was reported to vaccine staff, dystonia of right foot, flare of the patient crps complex regional pain syndrome condition in left arm, left foot and groin flare of patient dermatomyositis, weakened muscles, hives on face and neck, after vaccination following morning: intercostal and sternum pain. The patient received zyrtec and azelastine nasal spray as a treatment for the events. The outcome of events was recovered on an unknown date in 2021.; Sender's Comments: Based on vaccine-event chronological connection a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, as appropriate.
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| 54 | 2021-04-02 | abdominal pain |
After the first vaccine on 2/6/2021, I did not have any reaction except a sore arm until 2/10/2021 ...
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After the first vaccine on 2/6/2021, I did not have any reaction except a sore arm until 2/10/2021 when developed a bad headache causing me to leave work. When I awoke on 2/11/21 I felt worse as the day went on until I had complete flu like symptoms. On Friday, 2/12, I went to my primary care doctor and they did a COVID-19 test which was negative. Hence, I just waited for the reaction to go away, I was not better and able to resume normal activity until 2/15/21. I did decide to get the second shot as I was not entirely sure it was a result of the vaccine. On 2/27/2021, I received the second vaccination. Again, the immediate side effect was only a sore arm. On the following Monday (3/1/2021) see cont.I began to have what I thought was muscle aches and pains around the mid section on my body but they were manageable. On Tuesday and Wednesday (3/3/2021) the pain and area of the pain spread and intensified. I was unable to sleep or find a comfortable position and was losing strength and knew I needed medical attention as I was afraid it was a heart issue. My husband took me to the ER (3/4/2021). The ER doctor ran a CT scan with contrast and the result was a blood clot in my right lung and pneumonia in my left lung along with pleurisy. I was then admitted to Clinic on 3/4/2021. I remained in the hospital until 3/7/2021. There I was treated with IV antibiotics, warfarin, Lovenox (80mg), and pain medication for the pleurisy. I was also on a full time heart monitor and my heart was checked several times. Since returning home, I finished a dose of two antibiotics and am using an inhaler to help with breathing. I have also just finished a long dose of steriods. My INR is still not regulated to the therapeutic level. Prior to this reaction, I was in the therapeutic range and had been checked. As of 4/3/2021 I am at 1.8 not in the 2-3 range and have increased my dose from before the reaction at 7.5 mg to 9.0 mg daily.
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| 54 | 2021-04-03 | nausea |
covid test result=Positive; covid test result=Positive; Fever 103; chills; muscle ache; joint pain; ...
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covid test result=Positive; covid test result=Positive; Fever 103; chills; muscle ache; joint pain; nausea; extreme headache; injection site pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 20Jan2021 08:45 (lot number: E18982) as single dose at the age of 54 years old, for COVID-19 immunisation. Medical history included interstitial cystitis, palpitations, high cholesterol and covid-19. The patient was not pregnant at the time of vaccination. Concomitant medications included pentosan polysulfate sodium (ELMIRON), metoprolol, oxybutynin, rosuvastatin and Vit (unspecified); all taken for an unspecified indication, start and stop date were not reported. The patient previously took levaquin and experienced allergies. No other vaccines received four weeks prior to COVID vaccination. On 11Feb2021 02:30, the patient experienced fever 103, chills, muscle ache, joint pain, nausea, extreme headache, injection site pain, and tiredness. No treatment was given for these events. On 18Mar2021, the patient's COVID-19 test (nasal swab) was positive. The patient recovered from fever 103, chills, muscle ache, joint pain, nausea, extreme headache, injection site pain, and tiredness on unspecified date. Outcome of the COVID-19 test positive was unknown.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "covid test result=Positive" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.
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| 54 | 2021-04-11 | vomiting, diarrhea, nausea |
Is a 54-year-old female who presents today with nausea vomiting and diarrhea as well as body aches a...
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Is a 54-year-old female who presents today with nausea vomiting and diarrhea as well as body aches and a fever after taking her first Covid vaccination 2 days ago. She went to urgent care at first and they transfer her to the ER here. She has been out of her insulin for at least 3 weeks. She has had a refill of her glipizide and has not picked up a refill. She denies any chest or abdominal pain. She has had times where she is short of breath. She has had 3 episodes of nausea and vomiting and 3 episodes of diarrhea since midnight or in the last 19 hours.
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| 54 | 2021-04-12 | nausea |
Hallucinations; Fever; Shaking chills; Headache; Bodyaches; Flu-like symptoms; Teeth chattering; Arm...
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Hallucinations; Fever; Shaking chills; Headache; Bodyaches; Flu-like symptoms; Teeth chattering; Arm soreness; Extreme nausea; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm, at age 54 years, on 26Mar2021 09:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Patient's medical history includes multiple sclerosis, hypothyroid, postconcussive syndrome and migraines from unspecified dates. The patient is not pregnant. Patient did not have other vaccine in four weeks. Patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. Patient previously took codeine for unspecified indication and had known allergies on an unspecified date, and other unspecified medications in two weeks. Patient historically took first dose of BNT162B2 (Product=COVID 19, Brand=Pfizer, administration time=05:00 PM, Vaccine location= Left arm) on 03Mar2021 at age 54 years for COVID-19 immunization. On 26Mar2021 20:00, 11 hours after vaccine administration, patient experienced fever, shaking chills, headache, hallucinations, body aches, flu-like symptoms, teeth chattering, arm soreness, extreme nausea. Therapeutic measures were taken as a result of these events which include paracetamol (TYLENOL). COVID was not tested post vaccination. Facility type of vaccine was at a public health clinic/veterans administration facility. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 54 | 2021-04-14 | nausea, abdominal pain, vomiting |
Pfizer-BioNTech COVID-19 Vaccine EUA: three days after vaccination patient reports nausea, vomiting,...
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Pfizer-BioNTech COVID-19 Vaccine EUA: three days after vaccination patient reports nausea, vomiting, and abdominal cramping, Presents to oncology clinic with fever (temp 38.5 Celsius), rigors, and chills. Patient admitted to oncology service for fever and rigors while on immunosuppression.
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| 54 | 2021-04-18 | abdominal pain, nausea, diarrhea |
perforated appendicitis with appendectomy; Abdomen pain; diarrhea; acute gangrenous, perforated appe...
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perforated appendicitis with appendectomy; Abdomen pain; diarrhea; acute gangrenous, perforated appendicitis; minimal nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Mar2021 16:00 (Lot Number: EN6204) (at the age of 54-year-old) as single dose for covid-19 immunisation. Medical history included hypertension. The patient did not have covid prior vaccination. Concomitant medications included ascorbic acid (VIT C); zinc; ergocalciferol (VIT D); vitamin K2 (menaquinone); vitamin b complex (B COMPLEX) and multivitamin, all taken for an unspecified indication, start and stop date were not reported. The patient had known allergies: sulfamethoxazole, trimethoprim (SEPTRA), clindamycin, rabeprazole sodium (ACIPHEX), esomeprazole sodium (NEXIUM). The patient previously took the historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 26Feb2021 14:30 (lot number: EN6200) (at the age of 54-year-old) as single dose for COVID-19 immunisation. The patient experienced abdomen pain, minimal nausea, diarrhea, acute gangrenous, perforated appendicitis with appendectomy on 20Mar2021 14:00. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient hospitalized from an unspecified date in 2021 to an unspecified date in 2021 for 3 days. The patient received treatment included appendectomy. The patient underwent lab tests and procedures which included covid test (blood test) date on 22Mar2021 with result of negative. The outcome of the events was recovering.
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| 54 | 2021-04-24 | abdominal pain |
fast HB; Severe head ache; abdominal cramps; extremely high BP; This is a spontaneous report from a ...
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fast HB; Severe head ache; abdominal cramps; extremely high BP; This is a spontaneous report from a contactable consumer(patient). This 54-year-old female patient (not pregnant) received 2nd doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6204) at single dose via an unwon route in right arm on 26Mar2021 02:15PM for Covid-19 immunization. Medical history included hypothyroidism. Patient had no known allergies. Other medications in two weeks included levothyroxine and meloxicam. Patient did not have COVID prior vaccination. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6198) on 26Feb2021 in right arm for Covid-19 immunization. Patient experienced severe headache, abdominal cramps, extremely high blood pressure (BP) and fast heartbeats (HB), which was ongoing for 3 weeks as of 06Apr2021. The events onset date was 30Mar2021 08:00AM. The events resulted in Emergency room/department or urgent care. Treatment included IV fluids and BP medications. Lab data included CT scans and blood/ urine tests. The events were reported as serious with seriousness criteria of medially significant and life-threatening illness (immediate risk of death from the event). Outcome of the event was not resolved. Patient did not test for COVID post vaccination.
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| 54 | 2021-04-24 | nausea, decreased appetite, vomiting |
passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; so...
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passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; sores in her mouth and nose; sores in her mouth and nose; anal hemorrhoid sores; had difficulty speaking, with her words; has been dropping things, she has broken glass; her eye felt heavy and her eye was drooping; Dizzy; Fall; Slight fever; Fatigue; extreme pain through right side (right side means her shoulders, neck, torso, arm, and entire leg); first dose given 14Jan2021, and second dose given 07Mar2021; first dose given 14Jan2021, and second dose given 07Mar2021; Shortness of breath; severe nerve pain; Vomiting; had a feeling of urination, like she had to urinate when she didn't, that feeling of urination; Disorientated; eye pain like pins and needles; skin is burning and painful to the touch; Headache; joint and muscle pain; joint and muscle pain; Nausea; horrible lack of appetite/couldn't eat anything other than soup; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program called COVAX US Support. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 07Mar2021 (Lot Number: EN6204) as single dose for covid-19 immunization. The patient's medical history included history of three spinal surgeries (takes no pain meds, she is not on pain meds, she has never been on or kept taking them); and has "neuropathy and nerve related issues" that were not this bad since ten years ago in 2011, clarified that what she has is not actually neuropathy, something with the peripheral nerve, she says she doesn't remember actual verbiage), since ten years ago in 2011, and the only difference was this vaccination, it was not this bad until this vaccination. She doesn't react well to pharmaceuticals anyway (unspecified). Her medications are that she takes the minimum amount of medications, very minimal (unspecified). There were no concomitant medications. There was no other products. Also, she has not had any other recent vaccinations or started any new medications. For past drug, she didn't take anything other than 5mg of zolpidem tartrate (AMBIEN) to sleep at night because of her spine. Patient previously also took pregabalin (LYRICA) and was off it, was also on gabapentin or neurontin (patient did not have those medications to provide NDC/LOT/EXP for either of them because she took them back to the pharmacy or turned them in to the police station because she doesn't keep medications in her house if she isn't taking them, and she couldn't take that medication). Historical vaccine included first dose of bnt162b2 on 14Jan2021 (at the age of 54-year-old; Lot Number: EN5318) in Arm Right for covid-19 immunization, and for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. She received both doses of vaccine. Her first dose was LOT: EN5318 and was given 14Jan2021, and her second dose was LOT: EN6204 given 07Mar2021. The patient was reporting for Pfizer COVID-19 vaccine, for she was having a horrible reaction to it "45 days" (as reported) after taking 2nd dose, and had been in the ER, and her temperature still hasn't gone back down to her normal, her oral temp is still raised and her rectal is raised even more. She was not feeling well, she felt very bad, she would never get a vaccine again, that is how bad it was. Since "45 days" later she was still having significant pain and trouble flexing her right hand open and closed. For events treatment, she took over the counter Tylenol for fever and pain, strength unknown. Patient said she had not had this kind of disabling symptoms or anything before this vaccination. She had a slight fever almost the whole "45 days". On 08Mar2021, her oral temp was over 98 degrees Fahrenheit when her norm temp being 97.2 or 97.3degrees Fahrenheit. Her rectal temp stayed at 100 degrees Fahrenheit. The next day, actually on the 09Mar2021 (which was two days after her second dose), she had the slight fever, fatigue, and extreme pain through her right side. She said her right side means her shoulders, neck, torso, arm, and entire leg. She also had shortness of breath, and severe nerve pain. She called her primary care provider who said to wait 5 days to be seen. On day 5, or actually the whole five days (reported as in Mar2021), she was in bed and didn't leave her apartment because she was in bed and she was vomiting. On day 2 or within 6 hours of vaccination, she had a feeling of urination, like she had to urinate when she didn't, that feeling of urination was equivalent of having contrast dye (NDC/LOT/EXP: Unknown) put in her IV which makes her feel like she is peeing her pants but she did not, and that feeling has not gone away. On day 5 (11Mar2021), she was dizzy and fell. In Mar2021, she was disorientated and vomiting, she couldn't eat anything other than soup. On day two (Mar2021) she had some kind of eye pain that is still there "45 days later", it feels like pins and needles. Her skin was burning and painful to the touch, she couldn't keep an IV in her when she was in the ER. She was not admitted to the hospital. She was having headaches, and joint and muscle pain. She had nausea and vomiting at different times. She continued to have shortness of breath. She had a horrible lack of appetite. She had sores in her mouth and nose. She had anal hemorrhoid sores. Last night (05Apr2021 )she had a headache that was severe like someone put a knife behind her right eye, and when she got up (06Apr2021) her eye felt heavy and her eye was drooping. She also had difficulty speaking, with her words. She says she had passed out, and had been dropping things, she had broken glass. She has been to a neurologist and a gastroenterologist. She clarified that all of these events were after her second dose, for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. None of her doctors know what to do, her gastro doctor was giving her an anti inflammatory suppository and was going to do some tests. She had blood done from neurologist and at the ER and no one knows what to do, they keep referring her to other doctors. She wished someone could explain to her, but no one know and they said it was uncharted territory, they didn't know what to do. She is now back on Lyrica which she was off of but the ER prescribed her 300mg three times a day. She wanted to know what the hell is going on with this vaccine, and that she doesn't think having these side effects "45 days" out is normal. She wanted to be transferred to speak with someone about what to do because her doctor's don't know anything. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 54 | 2021-04-24 | nausea |
severe chest pain like severe heart burn attack/the doctors do not think it is heart burn/radiating ...
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severe chest pain like severe heart burn attack/the doctors do not think it is heart burn/radiating pain into the right arm and lymp nodes; blood pressure was through the rood; severe pain; cardiac issues; GI issues/GI malfunction of the pancreas and gallbladder; GI issues/GI malfunction of the pancreas and gallbladder; can not eat, work, or engage in daily activities/She is unable to eat and is very weak; can not eat, work, or engage in daily activities/She is unable to eat and is very weak; can not eat, work, or engage in daily activities; nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 09:45 (Batch/Lot Number: Unknown reported as either EN6205 or EM6205) as SINGLE DOSE for COVID-19 immunization; azithromycin (ZITHROMAX), via an unspecified route of administration from 26Feb2021 until 02Mar2021, at unspecified dose and frequency for dental care; and corticosteroid (CORTICOSTEROID), via an unspecified route of administration from an unspecified date with last dose shot on 23Mar2021 at unknown dose, once or twice a year for a couple of years for knee pain and joint pain . Medical history included dental procedure on an unknown date. Concomitant medications were not reported. On 25Mar2021 (9 days later), she developed severe chest pain like severe heart burn attack radiating pain into the right arm and lymph nodes, blood pressure was through the roof and was in severe pain. She was unable to eat, was very weak and also cannot work or engage in daily activities noted in Mar2021. The patient required emergency room and physician office visit due the events (including cardiac issue and GI issues/malfunction of the pancreas and gallbladder). She was hospitalized on 03Apr2021 and was just released on 04Apr2021. During hospitalization, doctors have ruled out cardiac issue and GI issues/malfunction of the pancreas and gallbladder and they cannot find out the cause. The patient received famotidine (PEPCID), omeprazole (PRILOSEC), pantoprazole (PROTONIX), acetaminophen (TYLENOL) as treatment. While in the hospital they gave her dicycloverine (BENTYL) which she thought was for nausea noted in 2021.She stated a week after she got the vaccine she got a corticosteroid shot which she was wondering if it can impact one's immune system and cause an adverse reaction with the vaccine. She also stated that a month prior to vaccine she took an azithromycin. She also was wondering with the combination of all these three things being close together if it may have caused a disruption in her body organic system. The action taken in response with the adverse event for azithromycin was post therapy while unknown for corticosteroid shot. The patient did not recover from chest pain while outcome of the remaining events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021376222 Pfizer
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| 55 | 2021-01-03 | diarrhea |
Severe chills, fever, headache, diarrhea Starting approx. 8:30 PM on 12/30/2020 until approx. 12:30...
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Severe chills, fever, headache, diarrhea Starting approx. 8:30 PM on 12/30/2020 until approx. 12:30 am 01/01/2021.
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| 55 | 2021-01-04 | nausea, vomiting |
Nausea; Vomiting; Headache; This is a spontaneous report from a contactable consumer (patient). A 5...
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Nausea; Vomiting; Headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 at single dose in right upper arm for COVID-19 immunisation. Medical history was none. There were no concomitant medications. On 29Dec2020 the patient experienced nausea, vomiting and headache: patient worked at the hospital; 30-45 minutes after she received the vaccine, she got really nauseated. She was also vomiting and had a headache. She has stopped vomiting on 29Dec2020 (30 min before the report). Events were all non-serious. Patient recovered from vomiting on 29Dec2020; outcome of nausea and headache was not recovered. Information on the lot/batch number has been requested.
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| 55 | 2021-01-04 | retching, abdominal pain upper, difficulty swallowing |
PATIENT VACCINATED AROUND 9AM. SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ...
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PATIENT VACCINATED AROUND 9AM. SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ABOUT 4-5 MINS. SHE FELT BETTER AND GOT UP TO WALK ABOUT 30 MINS LATER. SYMPTOMS WORSENED AFTER WALKING ~9:45AM: FAINT AGAIN, SEVERE RETCHING, BP196/140 TO 199/164, TROUBLE SWALLOWING, SOB, WHEEZING. AT 9:58AM, EPI PEN 0.3MG ADMINISTERED AND EMS ACTIVATED. SYMPTOMS REPORTED IMPROVED FOLLOWING EPI. EMS ARRIVED 10:05AM. PATIENT REPORTED RECEIVING 2 BAGS OF PEPCID, STEROIDS, AND ZOFRAN AT HOSPITAL. WAS RELEASED BETWEEN 11:30AM-12PM ON 1/4/21, BP 140/90 AND ACUTE SYMPTOMS RESOLVED. FOLLOW UP WITH PATIENT 1/5/21: NO PRIOR HX OF HTN, BP 120/60, NO SOB/ BREATHING DIFFICULTY. C/O SEVERE HEADACHE, LOW TEMP, FATIGUE, MUSCLE ACHES, SORE THROAT.
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| 55 | 2021-01-04 | nausea |
Vertigo/it is now full blown vertigo; Stuffy head; She does not feel safe walking in her home; Nause...
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Vertigo/it is now full blown vertigo; Stuffy head; She does not feel safe walking in her home; Nausea/ Acute nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK3730, expiration date: 20Mar2021), via an unspecified route of administration on 17Dec2020 at left deltoid, at single dose for covid-19 immunization. Medical history included patent foramen ovale in patient's heart from 2013 and ongoing, and the patient used to be 5'4" and noticed the shrinkage before the Covid 19 vaccine and baby aspirin. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) from 2013 and ongoing for patent foramen ovale. The patient got the Pfizer vaccine on 17Dec2020 and on 25Dec2020 had experienced acute nausea and dizziness that persisted during weekend. Stated that it is now full blown vertigo. Stated that her doctor and pharmacist stated that people reported symptoms but did not know if these were symptoms of the vaccine because it is not listed. The patient experienced stuff head on 28Dec2020. Stated that the nausea comes and goes. Stated that she got physical therapy treatment Epley for vertigo on 28Dec2020 and it did some good but she woke it with it again this morning on 29Dec2020. Stated that the therapy lessened her nausea as well. Stated vertigo was manageable 25-26 and then did not feel safe walking in her home on 26Dec2020. Stated that she had no symptoms after she received it up until 25Dec2020. Stated that she will get the second dose 07Jan2021. The outcome of the events was not recovered.
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| 55 | 2021-01-05 | nausea |
Nausea; Fatigued; chilled; Massive headache; Muscle and joint pain; Muscle and joint pain; This is a...
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Nausea; Fatigued; chilled; Massive headache; Muscle and joint pain; Muscle and joint pain; This is a spontaneous report from a contactable other HCP (patient). A 55-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in left arm on 29Dec2020 10:30 at first single dose for COVID-19 immunization. Medical history included COVID-19. Concomitant medication received within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient started with muscle and joint pain, within an hour had a massive headache (took ibuprofen). The next day patient began to feel fatigued, chilled, still massive headache, muscle and joint pain and nausea set in the second evening. On 31Dec2020 still had a massive headache but all other symptoms began to fade as the day went on. Currently the evening of the 31Dec2020 still a massive headache. Adverse event start date reported as 29Dec2020 01:15 AM. Events were considered as non-serious. No other treatment received for the adverse events (except ibuprofen). Since the vaccination, the patient had not been tested for COVID-19. Outcome of event headache was not recovered, of other events was recovering. Information about lot/batch number requested
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| 55 | 2021-01-05 | nausea | Queasy No taste headache tight neck- stiff |
| 55 | 2021-01-05 | difficulty swallowing | Rash, chest pain, tachycardia, numb tongue, hard to swallow |
| 55 | 2021-01-05 | decreased appetite, appendicitis |
Severe right lower quadrant pain, anorexia over 12 hours. Went to the emergency department. Lab resu...
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Severe right lower quadrant pain, anorexia over 12 hours. Went to the emergency department. Lab results showed elevated WBC and CT scan showed acute appendicitis. Admitted for urgent surgery: laparoscopic appendectomy. Was hospitalized from 12/26/20-12/28/20.
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| 55 | 2021-01-06 | diarrhea, vomiting, nausea |
12 hours after injection I had chills, body aches, fever, headache, nausea, vomited, diarrhea. Tempe...
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12 hours after injection I had chills, body aches, fever, headache, nausea, vomited, diarrhea. Temperature was in the 101.5 range for more than 24 hours, About 30 hours with a fever.
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| 55 | 2021-01-06 | vomiting, nausea |
Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall ...
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Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall weakness Narrative: Employee was unable to work second to symptoms, missing >1 days of work at time of this report.
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| 55 | 2021-01-06 | nausea, vomiting | Headache, NauseaVomiting, Fatigue |
| 55 | 2021-01-06 | nausea | Migraine sore arm nausea body aches stiff elbows |
| 55 | 2021-01-07 | nausea |
Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit o...
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Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit of nausea; Ear ringing; Left eye was twitching a lot; At 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on her arm on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included neuropathy in feet and thyroid condition. The patient's concomitant medications were not reported. Patient reported she was having some of the symptoms like the body ache and just the normal and not the really difficult symptoms or whatever just the tiredness, headache, muscle pain and chills, and pain and a little bit of nausea but last night her ears were ringing and her left eye was twitching a lot and she hadn't taken her temperature because she really didn't think she had a temperature. Then she decided to go ahead and take it and at 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101 and the information in the packet doesn't say like if she can take Tylenol or Motrin trying to get this headache to go away. The patient did not receive any treatment for the events. Outcome of the event headache was not recovered, ear ringing was recovering, left eye was twitching a lot was recovered, while the other events was unknown. No follow-up activities are needed. No further information is expected.
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| 55 | 2021-01-07 | nausea | By the evening pounding headache not relieved by Tylenol. Body hurts nausea still dizziness restless |
| 55 | 2021-01-07 | abdominal discomfort | Chil,bodyache, headache upset stomach |
| 55 | 2021-01-07 | nausea |
Dose 1 site soreness Dose 2 severe muscle and bone pain, chills, night sweats, fever, axillary lymph...
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Dose 1 site soreness Dose 2 severe muscle and bone pain, chills, night sweats, fever, axillary lymphadenopathy, fatigue, nausea-evaluation for symptoms- no prescribed treatment
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| 55 | 2021-01-07 | diarrhea, abdominal pain |
HA starting for 1 hour after injection, lasted for 24-26 hours despite Advil, Excedrine and Fiorocet...
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HA starting for 1 hour after injection, lasted for 24-26 hours despite Advil, Excedrine and Fiorocet Abdominal cramps with diarrhea starting 4 hours later, lasted another 4 hours (I get diarrhea very rarely)
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| 55 | 2021-01-07 | abdominal discomfort |
High fever 101degF for 36 hrs, headache, muscle pain, joints pain, stomach discomfort. Took Tylenol...
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High fever 101degF for 36 hrs, headache, muscle pain, joints pain, stomach discomfort. Took Tylenol every 6 hrs.
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| 55 | 2021-01-07 | nausea |
VERY sore joint (couldn?t walk using my knees). Very exhausted, migraine headache and slight nausea...
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VERY sore joint (couldn?t walk using my knees). Very exhausted, migraine headache and slight nausea.
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| 55 | 2021-01-07 | nausea |
left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection si...
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left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection site (4 cm in circumference); Nearly debilitating joint, muscle and body aches and pain; Nearly debilitating joint, muscle and body aches and pain; severe headache; chills; night sweats; weakness; dizziness; lethargy; fever; body aches; nausea; Muscle soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscularly in the left arm, on 23Dec2020 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, depression, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), and simvastatin (MANUFACTURER UNKNOWN). The patient previously took bupropion hydrochloride (WELLBUTRIN) and experienced allergy. The patient did not receive other vaccines within four weeks prior to vaccination. The patient experienced fever, body aches, nausea, and muscle soreness at injection site on 24Dec2020 at 16:00; generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches, severe headache, chills, night sweats, weakness, dizziness, and lethargy on 26Dec2020; and left arm and shoulder pain persisted on 03Jan2021. All of the events were reported as non-serious. The events were described as: Within 24 hours (as reported), fever, body aches, nausea, and muscle soreness at injection site occurred. Then within 72 hours (as reported), generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches and pain for three days with onset of severe headache, fever, chills, night sweats, weakness, dizziness, and lethargy. On Day 11 (as reported), left arm and shoulder joint pain persisted. The patient underwent lab tests and procedures which included nasal swab: negative on 31Dec2020. The patient did not receive any treatment for any of the events. The clinical outcome of all of the events was recovering.
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| 55 | 2021-01-08 | nausea, diarrhea | 1/08 12pm- Diarrhea 11pm- Nausea throughout the night 1/09 6am- Vertigo |
| 55 | 2021-01-08 | nausea, vomiting, diarrhea | Diarrhea & NauseaVomiting Narrative: jaw pain, metallic taste, cramps |
| 55 | 2021-01-08 | nausea |
Headache started 12/30/2020. Nauseous and dizzy off and on. Arm pain at injection site for 3 days. ...
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Headache started 12/30/2020. Nauseous and dizzy off and on. Arm pain at injection site for 3 days. Headache unresolved even after taking headache med, ibuprofen, oxycodone. Nausea and dizziness is intermittent.
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| 55 | 2021-01-08 | nausea |
fever, chills, body aches, nausea, headache, cough-over the counter meds symptoms lasted about 2-3 d...
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fever, chills, body aches, nausea, headache, cough-over the counter meds symptoms lasted about 2-3 days
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| 55 | 2021-01-09 | nausea, vomiting |
Pfizer-BioNTech COVID-19 Vaccine EUA~ 8 hrs after receiving second vaccine, developed severe nausea...
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Pfizer-BioNTech COVID-19 Vaccine EUA~ 8 hrs after receiving second vaccine, developed severe nausea & intense vomiting for several hours associated with severe chills and severe myalgia and severe arm pain (though no redness) at vaccine injection site. Vomiting/nausea continued despite Zofran x 2 and lasted ~ 8 hrs. The intense chills and myalgia lasted ~ 48 hrs- symptoms severe enough to keep me in bed for that time. Other than soreness at injection site and mild headache the next day, I had no adverse reaction after first vaccine dosage that was given on 12/21/20
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| 55 | 2021-01-10 | nausea | Fever, chills, headache, body aches, nausea |
| 55 | 2021-01-10 | nausea |
Fever, chills, nausea, achiness, fatigue started at 1:00am in 1/11. Now at 6:08 pm on 1/11, headache...
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Fever, chills, nausea, achiness, fatigue started at 1:00am in 1/11. Now at 6:08 pm on 1/11, headache and fatigue are persisting.
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| 55 | 2021-01-10 | nausea | Tiredness, queasy stomach, low energy, lethargic, headache, swelling and pain at injection site |
| 55 | 2021-01-10 | diarrhea, vomiting | fever, vomiting, diarrhea. called in sick to work. |
| 55 | 2021-01-11 | nausea | Headache, nausea, chills, Body aches |
| 55 | 2021-01-11 | abdominal pain upper, abdominal discomfort |
Stomach issues. Cramping in lower stomach. Tired. My GERD started to bother me and still not feeling...
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Stomach issues. Cramping in lower stomach. Tired. My GERD started to bother me and still not feeling well.
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| 55 | 2021-01-11 | diarrhea, nausea |
headache; chills; nauseous; did not feel very well at all; diarrhea; hemorrhoid; This is a spontaneo...
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headache; chills; nauseous; did not feel very well at all; diarrhea; hemorrhoid; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (medical assistant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on 02Jan2021 15:00 (3:00pm) at a single dose on the left deltoid as vaccination. The patient had no medical history. There were no concomitant medications. The patient reported having side effects from her first dose of Pfizer Coronavirus Vaccine administered on 02Jan2021. She tried reporting this information online but has been unsuccessful. Starting the evening of 04Jan2021, she had a headache, chills, felt nauseous, did not feel very well at all, diarrhea, and got a hemorrhoid. She still has a slight headache today; and when she woke up this morning, she felt a little nauseous but that went away; other side effects have improved at this time. Her doctor made her go get a Coronavirus test today in order to go back to work; because he said that the diarrhea and something else of the side effects, she did not remember were not a symptom of the Pfizer Coronavirus Vaccine. She had the Coronavirus test this morning on 06Jan2021 (unknown result); but would not get the results of that test until 48-72 hours after being tested. They would email her those results. Second dose was scheduled for 23Jan2021 at 3:45pm; she still plans to get the second dose. The outcome of the event nauseous was recovered on 06Jan2021 as it already went away while of the remaining events was recovering.
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| 55 | 2021-01-11 | abdominal pain |
headache; dizziness; fatigue; couldn't sleep; severe abdominal pain; This is a spontaneous report fr...
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headache; dizziness; fatigue; couldn't sleep; severe abdominal pain; This is a spontaneous report from a contactable healthcare professional (patient herself). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration on the left arm on 29Dec2020 11:30 at single dose for COVID-19 immunisation. Medical history included Addison's disease, papaya allergy, and gluten intolerance. Concomitant medications included hydrocortisone and fludrocortisone acetate (FLORINEF ACETATE). The patient verbalized, "At first, on 29Dec2020, I experienced only mild side effects such as headache, dizziness and fatigue. Later, I woke up in the middle of the night with severe abdominal pain and couldn't sleep the pain was so bad. I had to take the following day off due to abdominal pain and fatigue." No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
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| 55 | 2021-01-12 | vomiting, abdominal pain upper, decreased appetite |
12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck....
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12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck. 12/24/20 @ 0600 vomited x 2. Headache, runny nose, fatigue, general achiness---became worse as the day progress to include both hips and knees becoming painful. Shortness of breath with pulse ox levels of 91-97% on room air. Heart rate 104-124 bpm for 9 hours, Chest discomfort, cough, achy fingers, mild hand tremors, flushed face, nausea, decreased appetite, fatigue, chills . 12/25/20 @ 0120--severe muscle and joint pain---self medicated with 1000mg acetaminophen, stomach pain---used digestzen. tossed and turned until after 0428. 0920--increased area of painful lymph nodes: left arm axilla, breast and back of neck. Fatigue continues---although less than the day before 12/26/20 through 12/28/20 symptoms continue to decrease. 12/29/20----woke up feeling great. Took the stairs at work---no shortness of breath. At work received the mail out Covid test-----results were positive ( no symptoms of covid)
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| 55 | 2021-01-12 | abdominal pain | Chills, fatigue,full body aches, abdominal pains |
| 55 | 2021-01-12 | diarrhea | Mouth sores, diarrhea, joint pain |
| 55 | 2021-01-12 | nausea | chest tightness with shortness of breath; nausea for 10 minutes. Pain radiating to jaw |
| 55 | 2021-01-12 | vomiting | migraine with mild vomiting resolved by morning with medications |
| 55 | 2021-01-12 | vomiting, nausea |
vomiting; tiredness; severe headache; nausea; This is a spontaneous report from a contactable other ...
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vomiting; tiredness; severe headache; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm from at 00:00 on 06Jan2021 at single dose for COVID-19 immunization. Medical history included depression and anxiety. Concomitant medication included bupropion, vortioxetine hydrobromide (TRINTELLIX). The patient experienced tiredness, severe headache, nausea, vomiting at 08:00 AM on 06Jan2021. It lasted about 36 hours total. The events were reported as non-serious. The patient did not receive any treatment from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on 07Jan2021. Information on the Lot/batch number has been requested.
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| 55 | 2021-01-13 | nausea, vomiting | Awakened severe shortness of breath, chills, muscle shakiness and pain, nausea, vomiting |
| 55 | 2021-01-13 | abdominal pain upper, vomiting, nausea, retching, abdominal distension |
During the early morning following my second Covid vaccination, I started having fever and chills, m...
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During the early morning following my second Covid vaccination, I started having fever and chills, muscle aches, and a headache. I woke up about 230 am and my stomach was hurting. I thought I would have to have a bm in a little while but was able to go back to sleep. About an hour and a half later, I again woke up with stomach pain, maybe some bloating. I decided to go into the bathroom and I sat on the floor beside the toilet and began vomiting. I vomited 5 times and had one dry heave. The vomitus was clear in color, thin with some small pieces of food. I had felt very hot before vomiting, but was unable to check my temperature due tp nausea and vomiting. I checked my temperature a little while later and it was 100.2 F. I was able to go back to sleep for a while and kept checking temperature during the day. It was between 99.1 and 99.8 for most of the day.
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| 55 | 2021-01-13 | nausea, retching |
chills; body aches; headache; nausea; dry heaves; fatigue; This is a spontaneous report from a conta...
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chills; body aches; headache; nausea; dry heaves; fatigue; This is a spontaneous report from a contactable Nurse. This Nurse reported for self that the 55-year-old female patient received second dose of bnt162b2 (BNT162B2, brand:ELI,, Batch/lot number: 283), via Intramuscular on Left arm on 06Jan2021 03:30 PM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Known allergies to medications, food, or other products: Penicillin, sulfa drugs and Hypothyroid, genital herpes. Concomitant medications included the patient received within 2 weeks of vaccination: levothyroxine, Valacyclovir. The patient previously took first dose of bnt162b2 (BNT162B2, brand: EK, Batch/lot number: 5730), by injection via Intramuscular on Arm Right on 16Dec2020 03:30 PM at single dose for covid-19 immunisation. Facility type vaccine was Hospital. No other vaccine in fourweeks. At approximately 12 hours post injection chills, body aches, headache, nausea, dry heaves, fatigue from 07Jan2021 03:30 AM. No covid prior vaccination. No covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-13 | nausea | fatigue, nausea, generalized feeling "junk" |
| 55 | 2021-01-14 | nausea, vomiting |
Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am ...
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Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am 1/14, lasted until appx 12noon. On 1/15, appx 8am I awoke with nausea. Began to vomit and all my extremities began to tingle. At that point, my hands and feet became rigid. This spread throughout entire body, including my head. I was unable to move my hands or feet. My fingers were frozen so hard that my husband could not even close my hand for me. My tongue felt thick and I was having difficulty speaking. Husband picked me up off the floor and carried me to our bed. We were getting ready to call 911 when my feet began to wake up and the rigidity subsided for all areas. Epidsode lasted appx 15 mins.
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| 55 | 2021-01-14 | diarrhea, nausea |
Within 1 and 1/2 hours headache, nausea, diarrhea, cold sweats. Lasted for about another hour and 1...
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Within 1 and 1/2 hours headache, nausea, diarrhea, cold sweats. Lasted for about another hour and 1/2. Now feel weak. All other symptoms are gone.
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| 55 | 2021-01-14 | abdominal pain, vomiting |
fatigue the next day; sudden onset of chills/shaking; severe abdominal cramping and vomiting; severe...
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fatigue the next day; sudden onset of chills/shaking; severe abdominal cramping and vomiting; severe abdominal cramping and vomiting; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL3246), via an unspecified route of administration on the left arm on 07Jan2021 13:30 at SINGLE DOSE for COVID-19 immunization at the hospital. The patient had allergies with penicillin and sulfa drugs. The patient's concomitant medications were not reported. On 07Jan2021 22:30 (9 hours after vaccine), the patient had sudden onset of chills/shaking , severe abdominal cramping and vomiting which lasted about 1 hr 15 min and then resolved on 07Jan2021 23:45. It was reported that the patient had no other effects than fatigue the next day (08Jan2021). Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events. Outcome of the event of fatigue was unknown while remaining events recovered on 07Jan2021 23:45.
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| 55 | 2021-01-14 | vomiting, nausea |
nausea; vomiting; chills; headache; This is a spontaneous report from a non-contactable nurse (patie...
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nausea; vomiting; chills; headache; This is a spontaneous report from a non-contactable nurse (patient). A 55-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot no: EL1283), via an unspecified route of administration on 07Jan2021 at 10:30 AM on the left arm at a single dose for COVID-19 immunization. Medical history included allergies to sulfa. The patient's concomitant medications were not reported. The patient previously received the first dose of (Pfizer-BioNTech COVID-19 mRNA vaccine, lot no: EJ1685) on 21Dec2020 at 10:00 AM on the left arm for COVID-19 immunization. The vaccine was administered in the hospital. The patient was not administered any other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient experienced nausea, vomiting, chills and headache on 07Jan2021 at 11:45 PM. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported to be non-serious. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-15 | nausea |
Fever up to 102 degrees pain at site headache chills muscle pain nausea felt unwell Took Tylenol fo...
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Fever up to 102 degrees pain at site headache chills muscle pain nausea felt unwell Took Tylenol for fever and aches
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| 55 | 2021-01-15 | decreased appetite, nausea |
Sever body aches, chills, migraine headache, fever of 100,8, nausea, loss of appetite, extreme fatig...
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Sever body aches, chills, migraine headache, fever of 100,8, nausea, loss of appetite, extreme fatigue, pain a swelling a injection site.
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| 55 | 2021-01-16 | abdominal pain |
I received the first COVID vaccine from Pfizer. At first I experienced only mild side effects such a...
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I received the first COVID vaccine from Pfizer. At first I experienced only mild side effects such as headache and fatigue and dizziness. That night I awake with severe stabbing abdominal pain. I couldn't sleep much of the night due to pain. The pain continued until the following day. I had to take the day off work due to fatigue and pan. I have a couple of autoimmune diseases and I surmised this is why the vaccine affected me in this way
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| 55 | 2021-01-17 | nausea, vomiting |
12/27/20 - Presented to urgent care with Nausea, swelling on face and hands, SOB. Was given dose of...
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12/27/20 - Presented to urgent care with Nausea, swelling on face and hands, SOB. Was given dose of SoluMedrol 125mg and sent to the emergency room. 12/27/20 Presents feeling sick, body aches, chills, nausea, rash and vomiting. SOB better. Given Zofran and IV fluids in ER. D/C home with prednisone and Zofran. D/C dx: Acute allergic reaction, Nausea and vomiting
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| 55 | 2021-01-17 | nausea |
I had the vaccine on 12/20 and I started feeling cold couple of hours after the vaccine and chills o...
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I had the vaccine on 12/20 and I started feeling cold couple of hours after the vaccine and chills on 12/21/20. Mild body aches and soreness at site of injection and just feeling weird. This continued off and on 12/22, 12, 23 and etc. I thought it wasn?t a big deal as I had no respiratory symptoms and no fever. However, I just haven?t been well since then. I have ongoing nausea, head fog, severe weakness, very tired and just feeling unwell
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| 55 | 2021-01-17 | nausea, vomiting |
Received vaccine at 1600 on 1/14/2021. Woke up on 1/15/21 with nausea, vomiting, and headache. These...
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Received vaccine at 1600 on 1/14/2021. Woke up on 1/15/21 with nausea, vomiting, and headache. These symptoms improved by 1/16/2021 but continued to have HA all day on 1/16. Symptoms resolved on 1/17/2021.
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| 55 | 2021-01-17 | nausea |
Severe headache, nausea, extreme fatigue, body aches. Developed a temperature of 100.4 on Monday, 1...
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Severe headache, nausea, extreme fatigue, body aches. Developed a temperature of 100.4 on Monday, 1/14/21 at 2:40ish pm
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| 55 | 2021-01-17 | vomiting, nausea | only had fatigue, nausea and vomiting on day 3 after vaccination. no other symptoms. now resolved. |
| 55 | 2021-01-17 | nausea |
woke up the next day feeling nauseous, by 12 noon I had a fever 100.4 feeling very tired malaise and...
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woke up the next day feeling nauseous, by 12 noon I had a fever 100.4 feeling very tired malaise and headache. This feeling lasted for 24 hours. By Friday afternoon I was feeling better and by Saturday no reactions. Arm was sore for 24 hours
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| 55 | 2021-01-18 | nausea | Fever , joint pain, headache, weakness, nausea since 5 pm last night. |
| 55 | 2021-01-18 | nausea | Flush. SOB. Extremely nauseous. Rapid onset of fatigue |
| 55 | 2021-01-18 | abdominal discomfort, nausea, diarrhea |
Headache Injection site pain Feverish Chills Nausea Dizziness Feelin Unwell Tiredness Stomach Upset ...
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Headache Injection site pain Feverish Chills Nausea Dizziness Feelin Unwell Tiredness Stomach Upset Diarrhea
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| 55 | 2021-01-18 | abdominal discomfort | Light headed, mild stomach upset |
| 55 | 2021-01-19 | nausea |
Chills and headache beginning approximately 2 hours after injection. Proceeding to full body aches,...
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Chills and headache beginning approximately 2 hours after injection. Proceeding to full body aches, fever to 103, sweats and mild nausea over next 24 hours. Symptoms mitigated by use of Ibuprofen. 48 hours post vaccine, symptoms are resolving - minor headache and sweats remain. Afebrile.
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| 55 | 2021-01-19 | vomiting, nausea, diarrhea | nausea vomiting diarrhea |
| 55 | 2021-01-20 | nausea, abdominal pain |
About 13 hours after vaccine, fever to 100.4 F, shivering, chills, muscle aches, headache, nausea, f...
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About 13 hours after vaccine, fever to 100.4 F, shivering, chills, muscle aches, headache, nausea, fatigue, slight abdominal cramping. Throughout the day, fever continued despite Aleve and aspirin, but muscle aches began to subside with aspirin. Abdominal cramps lasted about an hour, and nausea went away after chicken soup and sleep. 24 hours after vaccine, fever coming down to 99.2F, muscle aches diminished, no nausea or fatigue, or abdominal cramping. The next morning, only a slight headache remained, no other symptoms.
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| 55 | 2021-01-20 | abdominal pain upper | BODY ACHES, COLD CHILLS, STOMACH PAIN, BAD FATIGUE |
| 55 | 2021-01-20 | nausea | Fatigue, nausea, headache, right axillary lymphadenopathy |
| 55 | 2021-01-20 | nausea |
Nausea; Vertigo; Dizzy; This is a spontaneous report from a contactable Nurse (patient). A 55-year-o...
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Nausea; Vertigo; Dizzy; This is a spontaneous report from a contactable Nurse (patient). A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot#: EJ1685, Expiry Date: Mar2021), via an unspecified route of administration on 07Jan2021 04:30 at single dose for COVID-19 immunization. Medical history included GERD (Gastrooesophageal reflux disease). Concomitant medication included montelukast sodium (SINGULAIR), pantoprazole sodium sesquihydrate (PROTONIX) for GERD, omeprazole for GERD. The patient experienced nausea on 08Jan2021, vertigo and dizzy in Jan2021. Investigation Assessment: No. The patient received the second dose of Pfizer COVID Vaccine (later confirmed) on 07Jan2021 around 4:30. And since 08Jan2021 night till now, the patient was feeling, it started out with nausea and now it's just vertigo. The patient had been in bed since 08Jan2021 night, pretty much except to get something to eat or drink. The patient just very dizzy. When probed if the product was prescribed by a doctor, consumer stated, "The hospital, the patient worked there." Treatment: the patient had some Meclizine, took it once it didn't do anything, 12.5 mg. The outcome of all the events was unknown. Causality: the patient thought yes.
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| 55 | 2021-01-20 | nausea |
Patient experience nausea same day as injection as well as numbness of tongue and pain when swallowi...
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Patient experience nausea same day as injection as well as numbness of tongue and pain when swallowing.
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| 55 | 2021-01-20 | vomiting |
several fainting spells because of everything going on; elevated HR in the 130's; Uncontrollable chi...
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several fainting spells because of everything going on; elevated HR in the 130's; Uncontrollable chills; fever of 102.8; pain all over my body; intractable vomiting; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EL0140, via an unspecified route of administration in left arm on 07Jan2021 10:45 at single dose for covid-19 immunisation. Medical history included covid-19 on an unknown date prior vaccination. There were not known allergies. Covid was not tested post vaccination. Concomitant medication included vitamin D; vitamin E. On 08Jan2021 at 02:00 the patient experienced several fainting spells because of everything going on, uncontrollable chills, fever of 102.8, pain all over the body, elevated heart rate in the 130's, and intractable vomiting. The patient was not treated for the events. The outcome of the events was resolved in Jan2021.; Sender's Comments: Based on the time association, all events are reasonably related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 55 | 2021-01-20 | nausea, diarrhea |
severe muscle pain; joint pain; temperature 102.3; headache; nausea; fatigue; generalized body aches...
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severe muscle pain; joint pain; temperature 102.3; headache; nausea; fatigue; generalized body aches; diarrhea; This is a spontaneous report from a contactable physician (patient). A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (left arm) on 07Jan2021 (17:45) at single dose for Covid-19 immunization. The patient previously received the first dose of BNT162B2 (lot number: EL1283) on 19Dec2020 (01:15 PM) via an unspecified route (left arm). Medical history included asthma and "known allergies: yes". Concomitant medications included fish oil (OMEGA 3), colecalciferol (VITAMIN D), ascorbic acid (VITAMIN C), and meloxicam. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe muscle pain, joint pain (fingers, skin!-pending clarification), temperature 102.3, headache, nausea lasting 24hours, followed by persistent fatigue and generalized body aches and diarrhea for the next 24hours. The patient was treated with acetaminophen. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
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| 55 | 2021-01-21 | nausea |
1/19/2021 2nd vaccine Pfizer. background headache post vaccine, still present 1/22/2021. 1/21/202...
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1/19/2021 2nd vaccine Pfizer. background headache post vaccine, still present 1/22/2021. 1/21/2021 cold, low temp 93F, then registering "Low" on hand help Temp unit. Temp unit did register normal temp for other people so not a issue with unit. naseaous, very tired. resolved by 1/22/2021
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| 55 | 2021-01-21 | abdominal pain |
Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspot...
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Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspots: @ 12hrs temp 102.6 F: @ 15hrs Oxygen desaturation 89-90%, weakness, extreme fatigue Seen at ED aprox 6PM on 1/9/21: CBC, chem panel, CT abd, CXR Continued to have low sats and was admitted to hospital on 1/10/21 adverse reaction to vaccine, Reactive airway, asthma excerbation discharged on 1/12/21
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| 55 | 2021-01-21 | vomiting | FEVER 101 FOR 24 HRS/ BODY ACHES/ VOMITING/ TOOK ACETAMINOPHEN. |
| 55 | 2021-01-21 | nausea |
Mild headache , mild nausea . 3 separate events the next day 1/21 /2021 where I had sudden , no war...
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Mild headache , mild nausea . 3 separate events the next day 1/21 /2021 where I had sudden , no warning , fall to floor . Possible loss of consciousness. Today 1/22 no events of sudden falls or hitting floor
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| 55 | 2021-01-22 | difficulty swallowing |
After waiting the 15min post vaccine, went to my car, I took 1 Tylenol 500mg pill and ate a banana, ...
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After waiting the 15min post vaccine, went to my car, I took 1 Tylenol 500mg pill and ate a banana, noticed trouble swallowing, coughed up some banana , took a drink of water. I then felt my lymph nodes in my neck were swollen. Waited another 15 min in the parking lot, went back into the to use the bathroom and to make sure symptoms were not progressing. At this point it had been approx 45min post vaccine and no other symptoms. 24 hrs later symptom had resolved.
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| 55 | 2021-01-22 | vomiting |
Early in the evening I began to feel abnormally tired. After going to bed, I woke up at midnight fr...
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Early in the evening I began to feel abnormally tired. After going to bed, I woke up at midnight freezing with the same type of body chills I had during COVID. At 4:00 a.m. I woke up drenched in sweat from head to toe. I got up to change my cloths and felt dizzy. I then began vomiting. I returned to bed and basically slept all day. Through out the day I had body aches and pretty severe aches in my joints and hips. I did take some tylenol around 1:00 p.m. I began to feel less achy around 4:00 p.m. Today is the second day and I feel better but still tired and somewhat achy. I just took additional tylenol.
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| 55 | 2021-01-23 | diarrhea |
1/11/21 6:00 pm low grade fever 99.5, body aches 1/12/21 same 1/13/21 morning, no fever, felt better...
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1/11/21 6:00 pm low grade fever 99.5, body aches 1/12/21 same 1/13/21 morning, no fever, felt better, went to work 1/13/21 12 noon started feeling poorly, headache, body aches 1/13/21 5 pm severe headache, 100.5 fever, chills, severe muscle and joint pain 1/13/21 5:15 began rotation of 800 mg Ibuprofen, 500 mg Tylenol every 2 hours, bed ridden 1/14/21 1:00 am fever of 101.5 on medication, severe aches and chills 1/14/21 2 pm no fever, severe headache and body aches, bed ridden 1/15/21 6 am severe headache , no fever mild body aches, started gastrointestinal symptoms diarrhea 1/16 & 1/17/21 severe headache and diarrhea 1/18/21 felt better, returned to work
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| 55 | 2021-01-24 | abdominal pain upper, nausea |
I had serve tenderness and redness at the site I had dizziness, headache, feeling, tired, I felt lik...
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I had serve tenderness and redness at the site I had dizziness, headache, feeling, tired, I felt like I had flu, chills, nausea, stomach cramps, muscle pain, joint pain. I had some insomnia. I had this for about 3-4 days after. I started feeling better on Saturday and got the vaccine on a Tuesday. I spoke to my Dr. about it and we decided to take Tylenol and a lot of baths.
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| 55 | 2021-01-24 | nausea |
I had vaccine at 8:30 and 11 i started having palpitations and chest pressure and light headed and d...
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I had vaccine at 8:30 and 11 i started having palpitations and chest pressure and light headed and diaphoretic while i was at work. i continued to work and didn't go home until close to 4pm, i thought it would go away like the first time but it didn't, i went home and laid down and took a zanax and it didn't go away. the next morning i went to the ER and they put me on a telemetry monitor and i was having bigeminy and palpitations and i thought my heart was going to come out of my chest and was hurting they gave me 4mg of morphine, 2 hrs they gave me more morphine, i was nauseated they gave me Zofran then it finally subsided later but till had bigeminy and chest pressure, they admitted me and i stayed overnight. i had the PVC and bigeminy slowed down i had an echo and it was normal the potassium was low and they gave me kedar, i was still ight headed and nauseated they gave me Zofran prn it was 4-5 doses they gave me IV fluid, my fever with up to 100.4, i was not really eating that 24 hrs because i was afraid to throw up. the doctor gave me meds to take home to manage light symptoms . i went home and felt tired and had more palpitations when i move around too much and I'm still having issues today. i have not gone back to work since the vaccination and have an appointment with cardiologist 2:pm tomorrow and today I will see my PCP at 1pm. I have not recovered and still having issues and very tired.
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| 55 | 2021-01-24 | nausea |
Intense throbbing and pain at injection site, severe nausea, got up to vomit in bathroom, fainted an...
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Intense throbbing and pain at injection site, severe nausea, got up to vomit in bathroom, fainted and hit my head, was unconscious a couple of minutes.
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| 55 | 2021-01-24 | decreased appetite, nausea |
On 1/20/21 awaken at 1 am with excruciating pain right arm, shoulder, neck, head and right axilla. S...
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On 1/20/21 awaken at 1 am with excruciating pain right arm, shoulder, neck, head and right axilla. Sever shivers, sweating, whole body aches, lethargic, nausea, loss of appetite, low grade fever, developed golf tennis ball size lump right axilla.
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| 55 | 2021-01-25 | decreased appetite |
When i first got the shot I didn't think it was bad at all I actually hardly felt the needle. aroun...
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When i first got the shot I didn't think it was bad at all I actually hardly felt the needle. around 5 o'clock I started feeling ill and then i started about quarter to 6 I started getting cold and shaking bad but it wasn't like a seizure. So really severe chills. When i got home i got under heated blanket then I started getting itchy and noticed hives all over body. then I started getting blisters on palms of my hands and they were like water blisters. I was uncontrollably itchy. I started looking up online what to do and asked friends and family and started taking Benadryl. I had to take it for 4-4.5 days so then the hives finally went away but I was still itchy. I've just been very very exhausted and been having to push myself to get up. I had anxiety about getting the vaccine but I decided to get it. I still don't feel like myself, I don't have much of an appetite but not losing weight because I've been forcing myself to eat. I'm taking vitamins and praying I feel better but I just don't feel like myself. I don't have as much energy and exhaustion is the big thing. My joints started hurting really bad.
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| 55 | 2021-01-26 | nausea |
Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a sp...
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Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3248), via an unspecified route of administration on 08Jan2021 14:30 (reported as 02:30 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history included Attack cardia, reflux and arthritis. Concomitant medications (other medications in two weeks) included amoxicillin, verapamil, omeprazole, estradiol (ESTROGEN) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No other vaccine in four weeks. The patient previously took morphine, Remeron, azithromycin and digoxin and experienced allergies. No COVID prior vaccination. The patient experienced soreness in neck, headache, nausea, joint ache, jaws hurting, rapid heartbeat and fatigue on 09Jan2021 8:00 AM. No treatment received for the events. Outcome of the events was recovering. Patient was not tested for COVID post vaccination.
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| 55 | 2021-01-26 | nausea, vomiting |
dizzy; cold chills/chills; a little headache; nausea/nauseated/nauseous; vomiting/ vomited; This is ...
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dizzy; cold chills/chills; a little headache; nausea/nauseated/nauseous; vomiting/ vomited; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: Apr2021) via an unspecified route of administration on left deltoid on 12Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient stated she had a shingles vaccine, got dizzy and nauseous, thought this was about 3 years prior to the report. The patient received the first dose of the vaccine after working a night shift. She went home, went to bed and then woke up very dizzy, nauseated, vomited and experienced cold chills on and off. She also stated that about 10 hours after she got the shot, she got dizzy, nauseous, threw up a couple of times, got chills, and had a little headache on 12Jan2021. She stated she was a little nervous about getting the second vaccine. She also worked nights and that she got off her night shift and got the vaccine on 12Jan2021, didn't know if maybe she was a little dehydrated possibly. The events are reported as serious due to medically significant. The outcome of the events nausea/nauseated/nauseous and vomiting/ vomited was recovered on 13Jan2021, for the events dizzy, cold chills/chills and a little headache were recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-01-26 | decreased appetite |
frequent urination; sudden extreme fatigue; headache/headache began receding from the front to back ...
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frequent urination; sudden extreme fatigue; headache/headache began receding from the front to back of head and down back of neck; sore injection site; heavy metallic taste; no appetite; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 11Jan2021 08:30 at single dose in right arm for COVID-19 immunization. The patient medical history included obesity and known allergies to sulfa and penicillin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 21Dec2020 11:30 at single dose in left arm for COVID-19 immunization and experienced mild metallic taste and arm soreness (including extreme burning for 10 min following vaccination, the patient believe this was poor administration tech), slight metallic taste 24 hrs post vaccination, lasted a few hours. Concomitant medications in two weeks included metoprolol, colecalciferol (VIT D3), Calcium, ascorbic acid (C) and probiotic. The patient had no covid prior vaccination. It was reported that after the second vaccination, the patient had no burning at site, on 11Jan2021 09:30 the patient had heavy metallic taste approximate 40 mins post vaccine and lasted approximate 12 hrs, at 12 hrs post vaccine (on 11Jan2021 20:30) sudden extreme fatigue, 15 hrs post vaccine (on 11Jan2021 23:30) frequent urination began and lasted approximate 18 hrs. The patient woke up with headache 6/10 that medication would not touch, no appetite but ate and drank anyway hoping would help with headache (it didn't) (reported on 11Jan2021 09:30), approximate 32 hrs post vax headache began receding from the front to back of head and down back of neck. Slept well and woke up 48 hrs post vax feeling normal but with sore injection site (reported as on 11Jan2021 09:30). The patient underwent lab tests and procedures related to covid included nasal swab and PCR with negative result on 04Jan2021. No treatment was received for the events. The outcome of the events was recovered in Jan2021.
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| 55 | 2021-01-27 | nausea |
Moderately uncomfortable headache non-stop for 2 1/2 days so far, during waking and sleeping hours. ...
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Moderately uncomfortable headache non-stop for 2 1/2 days so far, during waking and sleeping hours. Nausea at waking up, for several hours, all three mornings. Occasional nausea in afternoons/evenings. Feeling in throat like I have a cold or flu.
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| 55 | 2021-01-28 | nausea | Soreness in left arm, fever, severe headache, nausea, weakness. |
| 55 | 2021-01-28 | nausea |
Woke up 11 hours after vaccinated with chills and weakness/tiredness. Felt like sandbags were weighi...
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Woke up 11 hours after vaccinated with chills and weakness/tiredness. Felt like sandbags were weighing me down. I also had a migraine, nausea, joint discomfort mostly in my shoulders hips, lower back and base of head. I slept most of the day into the next day and felt better approximately 46-48 hours after the vaccine administration. Slight headache continued and swollen lymph nodes in the armpit noticed day 2 and continue to this day. Alternated Tylenol 1000mg PO w/ Advil 400ng PO.
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| 55 | 2021-01-29 | abdominal pain upper, vomiting |
Felt flushed and tired by 8pm that night of injection,Jan 12. Woke the next morning with worst heada...
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Felt flushed and tired by 8pm that night of injection,Jan 12. Woke the next morning with worst headache I've ever had, in addition to horrible neck stiffness. Slept most of the day. Felt awful. 28 hours after vaccine started vomiting. Vomited for almost 24 hours. Had stomach pain the night of the 15th. Had a low grade temp the next day 16th and on the 17th my heart rate was elevated as high as the 150's. The whole time I was tired. I was Covid tested the 14th because symptoms were so severe but it was negative. I was abnormally tired but finally felt normal by January 19th.
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| 55 | 2021-01-31 | diarrhea |
Immediately after receiving the 2nd dose of the Pfizer vaccine, I had muscle pain at the injection s...
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Immediately after receiving the 2nd dose of the Pfizer vaccine, I had muscle pain at the injection site and difficulty lifting that arm the next day (similar reaction as after the 1st dose). I received the vaccine Wednesday evening (6 p.m.) on 1/13/21. Around 2 p.m. the next day, I started having a fever (over 101 degrees); chills; body aches; and fatigue. These symptoms lasted for three days but the fever was slowly going down with Advil. By Saturday evening, my symptoms changed to headaches and diarrhea, which lasted for an additional three days after that. My nose suddenly started running the following afternoon (Wednesday, 1/20/21) for about an hour and then that stopped and did not recur. All symptoms were gone by Thursday, 1/21/21 and I had none of these symptoms prior to taking the second dose of the vaccine (other than the arm pain for 1-2 days following the 1st dose of the vaccine).
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| 55 | 2021-01-31 | nausea |
Severe Dizziness; nausea; body pain; It felt heavy and temporary unable to raise; Severe chills (fel...
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Severe Dizziness; nausea; body pain; It felt heavy and temporary unable to raise; Severe chills (felt like all my internal organs are frozen cold); heartbeat sounded strong beats (can feel the pump); Body weakness; muscle weakness; It felt heavy and temporary unable to raise; This is a spontaneous report from a contactable consumer reported for herself. This 55-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at left arm on 14Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced severe dizziness (BP normal at 120/80), nausea, body pain, while sideways lying down: unable to raise right foot or raise her foot. It felt heavy and temporary unable to raise for two days, severe chills (felt like all my internal organs are frozen cold), heartbeat sounded strong beats (can feel the pump) for at least 2 days, body weakness or muscle weakness.Start date for all events were 14Jan2021. Meclizine 25mg was received as treatment. The patient had no Covid tested post vaccination. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient had no known allergies. The patient had all normal from blood glucose of 109 and bp 120/80 on 14Jan2021, day of vaccine was a perfect day. Outcome of all events was recovering. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-31 | diarrhea |
Stiff neck/ muscles , daily headache, cough, fatigue and diarrhea Shingles on face resultant after ...
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Stiff neck/ muscles , daily headache, cough, fatigue and diarrhea Shingles on face resultant after 4 days. Oral medication/ valacyclovir 1 G tab every 8 hrs. For 7 days.
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| 55 | 2021-01-31 | nausea |
The day after the vaccination I had redness around my whole shoulder and arm. On the third day I dev...
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The day after the vaccination I had redness around my whole shoulder and arm. On the third day I developed swelling of my shoulder and neck with horrible pain when I breathe. I went to urgent care and had an x-ray which was clear and they were treating me for myalgia with Motrin. I refused any narcotic pain medication or a Toradol shot. The pain never stopped on the 19th I went to Work Force Safety and reported it and I was examined by the nurse practitioner who saw all the swelling and the pain that I was in. That nurse practitioner told me if it wasn?t better in a few days to go to the emergency room to be examined. On January 23 , I developed swelling and pain went underneath my armpit it?s a burning pain that?s constant since the third day after my injection. My blood pressure was 153/104 and I was having nausea and not feeling well at all. On January 25 the pain and swelling were still there I went to work for a few hours and I went to the emergency room. They gave me lidocaine patch and Zofran for the nausea my blood pressure was 159/103 and I had an ultrasound to rule out a blood clot there was no blood clot but there was lymphadenopathy under my arm hurt and swelling and inflammation around the shoulder. The chest x-ray showed left pleural effusion / Pneumonia. My oxygen saturation was 93 and they wanted to admit me but I am a single mom with a new diabetic 14-year-old at home so they let me go home with a pulse oximeter and a prescription for doxycycline For 10 days. They called me the next day from the emergency room to follow up with a pulmonologist and cardiologist. On January 28 I saw the pulmonologist who did an ultrasound in his office and saw the fluid on my left lung. He said that most likely because the technique of the injection was so high in my shoulder that they probably had a nerve and I did have the swelling in the lymphadenopathy and all the pain and it hurt when I breathe so I wasn?t breathing correctly and I was splitting my arm against me and that?s how I probably developed plural effusion and pneumonia. I am following up with him on February 4. I still have shortness of breath and my oxygen saturation is 93. I am also on two inhalers that the pulmonologist ordered.
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| 55 | 2021-01-31 | nausea | edema lymph node left axilla , nausea, |
| 55 | 2021-01-31 | abdominal pain upper |
severe chills extreme body aches arms and legs can hardly walk low grade fever fever 101. stomach pa...
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severe chills extreme body aches arms and legs can hardly walk low grade fever fever 101. stomach pain sharp pain in stomach headache
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| 55 | 2021-02-03 | diarrhea |
Headache; Body aches; Diarrhea; This is a spontaneous report from a contactable nurse. A 55-year-old...
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Headache; Body aches; Diarrhea; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received bnt162b2 (brand: Pfizer), lot/batch no. and expiration date not provided, intramuscular on 20Jan2021 at a single dose for COVID-19 immunization. Medical history included diagnosed with COVID-19 prior to vaccination. Concomitant medications included unspecified vaccine/s. The patient received other vaccines within 4 weeks prior to the COVID vaccine. The COVID-19 vaccine was administered at a nursing home/senior living facility. The patient was not pregnant at the time of vaccination. The patient experienced headache, body aches, diarrhea on 20Jan2021. No treatment received for the adverse events. All events were assessed as non-serious (did not result to death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, and no congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 55 | 2021-02-03 | diarrhea |
I got my first Covid19 shot (Pfizer) at noontime on Wednesday January 27, 2021 12 hours later, abou...
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I got my first Covid19 shot (Pfizer) at noontime on Wednesday January 27, 2021 12 hours later, about 12pm I start having side effect: Left Arm sore, hurt to lift (arm that was injected) Farting up a storm in my sleep Wednesday night, waking me up constantly, horrible weird smell, my poor husband, I moved to the couch and stunk up the first floor. Then diarrhea few hours later, about 4am, slight intestinal cramps, not bad. I was able to get ready and go to work for 6am. On Thursday January 28 Farting was over, thank goodness. As the morning went on I felt like I did when I originally had the Covid19 in May. I had to leave work at 10:30am due to: aches every where in body Especially neck hurt My left arm hard to lift or use (injection was in left arm), hard to think and concentrate (brain fog), chills Able to eat some soup Slept several hours at home, felt slightly better, than slept nine hours that night On Friday January 29th felt much better and arm hurt less to lift it. On Saturday January 30th Under my arm, glands are swollen and hurt to touch. All other symptoms have subsided Sunday January 31, glands under arm are better, much less sore Monday February 1st glands under arm, back to normal
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| 55 | 2021-02-03 | abdominal pain upper | Lump with chronic mild pain at base of lower rt lobe/ upper rt quad abd. Just below ribs |
| 55 | 2021-02-03 | abdominal pain |
Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Pati...
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Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Patient states she is not anxious. She then started feeling like her throat and chest were getting itchy. Continued monitoring and she felt she needed to be evaluated in ER. Taken to ER. ED notes as follows: 55 y.o. female who arrived by to the emergency department for Throat and chest discomfort associated with voice change and pruritic rash. Past medical history of food and environmental allergies, Addison's disease, thyroid disease, primary immune deficiency disorder. Half an hour ago, the patient received her first injection the Covid vaccine. Seconds later, the patient started having a pruriti rash where the site of the injection was. She then noticed her chest getting red and warm. About 15 minutes later, the patient noticed her voice becoming hoarse her and associated with throat and chest discomfort. Reports that she is unable to take a deep breath. Denies any noisy breathing, nausea, vomiting, abdominal pain, shortness of breath, difficulty swallowing, drooling. She has never been hospitalized for anaphylaxis. She denies any past medical history of asthma or COPD Vital signs demonstrate hypertension with systolic blood pressures into the 180-190s. No oropharyngeal swelling. Hoarse voice. Scleral injection present bilaterally. Chest wall nontender. Mild, blanching, erythematous, pruritic rash on anterior chest. Shallow breathing when asked to take a deep breath. Injection site covered with bandaid with no other obvious rashes or swelling patient arrived to the ED in no acute distress and in stable condition. She was complaining of throat discomfort with voice changes. She has never had an anaphylaxis reaction before. She was given benadryl, famotidine, and methylprednisolone initially for her reaction. With her hypertension and reported chest discomfort, epinephrine was not given initially.  Her symptoms mildly improved with the initial treatment.  Patient complained of chest discomfort and EKG showing T wave inverted in leads V4-5. She was given aspirin. Initial troponin negative and repeat was ordered.  After four hours of observation, the patient reports her voice change has resolved but continued to have pruritis in different, migrating areas of the body such as ears, neck, and arms.  1330: patient complaining of increasing chest and abdominal pain. Described as a cramping chest pain that radiated to her abdominal. Denies nausea, vomiting or diaphoresis. Continues to deny shortness of breath. Given morphine for her pain and aspirin for her nonspecific EKG changes.  Internal Medicine consulted for admission due to allergic reaction. Patient is agreeable to this plan. Patient was transferred under stable condition to the IM service. Initial Vital Signs [02/03/21 1159] Blood Pressure 168/101 Heart Rate 73 Respiratory Rate 15 Temp 36.8 °C (98.3 °F) Temp src Oral SpO2 96 % Following one day admission she was discharged to home with Zio patch monitoring while on new beta-blocker therapy for symptomatic PVCs with plan for PCP follow-up. Regarding adverse drug reaction, she was advised to follow-up with PCP and immunologist for further discussion on benefits:risk of subsequent vaccine in series.
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| 55 | 2021-02-03 | diarrhea |
Projectile vomiting for 2 hours. Extreme diareah for 8 hours. Fever and chills over a duration of ...
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Projectile vomiting for 2 hours. Extreme diareah for 8 hours. Fever and chills over a duration of 24 hours.
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| 55 | 2021-02-04 | nausea | Nausea, lightheadedness, diaphoresis, bruising, and radiating pain from injection site. |
| 55 | 2021-02-04 | difficulty swallowing | Pt stated she could not swallow as well as she normally does. Pt did not complain of SOB. |
| 55 | 2021-02-04 | nausea |
nausea; body aches; headache; fatigue; tingling in both hands (and fingers); crushing depression; Th...
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nausea; body aches; headache; fatigue; tingling in both hands (and fingers); crushing depression; This is a spontaneous report from a contactable healthcare professional. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the left arm on 19Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included osteoarthritis, restless legs syndrome, rubber sensitivity (latex allergies), and COVID-19. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included ropinirole. On 19Jan2021 14:15, the patient experienced nausea, body aches, headache, fatigue, tingling in both hands (and fingers) and crushing depression. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 55 | 2021-02-05 | nausea | Fatigue, muscle aches, nausea, chills |
| 55 | 2021-02-06 | nausea |
Chills, Fever, muscle pain, spasm, headache, stuffiness, dizziness, weakness, nausea, cramps, fatigu...
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Chills, Fever, muscle pain, spasm, headache, stuffiness, dizziness, weakness, nausea, cramps, fatigue, heaviness in legs, needle sticking sensation on hands and feet, sore left arm (limited mobility)
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| 55 | 2021-02-07 | nausea | H/A, nausea, chills |
| 55 | 2021-02-07 | difficulty swallowing |
Heart rate went from normal (53-60) to 100 bpm; Felt flushing feeling; blood pressure went up to 127...
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Heart rate went from normal (53-60) to 100 bpm; Felt flushing feeling; blood pressure went up to 127/90 (usually 90/60); Had difficulty swallowing; Fingers started tingling; Chills (lasted 15-20 minutes); This is a spontaneous report from a contactable consumer. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant. Patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. On 15Jan2021, after 2 minutes of the vaccine, patient heart rate went from normal (53-60) to 100 bpm; the patient felt flushing feeling and blood pressure went up to 127/90 (usually 90/60); patient had difficulty swallowing and fingers started tingling, followed by chills (lasted 15-20 minutes, as reported). The patient was ok 90 minutes after the shot. No treatment given. The final outcome of all the events was recovered in Jan2021.Information on the batch/lot number has been requested.
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| 55 | 2021-02-07 | nausea |
Night chills/sweating; HR of 130/HR was 120; soreness and bumps to anus; soreness and bumps to anus;...
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Night chills/sweating; HR of 130/HR was 120; soreness and bumps to anus; soreness and bumps to anus; Bodyaches; fever; chills/Night chills; nausea; headache/mild headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 07Jan2021 at a SINGLE DOSE for COVID-19 immunization. Medical history included palpitations. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 on 18Dec2020 at 17:00 via intramuscular route of administration in the left arm for COVID-19 immunization. Concomitant medication included atenolol, vitamin b complex, colecalciferol (VITAMIN D), vitamins (MV), esomeprazole magnesium (NEXIUM), omeprazole (PROTON) and fish oil. The patient previously took morphine and experienced allergies. On 08Jan2021, 1 day post-vaccination after the second dose of vaccine, the patient experienced body aches, fever, chills, nausea, headache and muscle weakness. Then on 18Jan2021, she had night chills and sweating, HR (heart rate) of 130, and mild headache. She also noticed soreness and bumps to anus on 18Jan2021. On 19Jan2021, patient still had chills, HR was 120 and continue to feel muscle weakness Took 100mg atenolol to decrease HR. Usually prn 25 mg atenolol. The soreness and bump increase and was growing. Patient will consult with cardiologist regarding HR. The outcome of events body aches, fever, nausea, headache and was recovered on 13Jan2021. The outcome of event chills, muscle weakness, soreness and bumps to anus was not recovered. The outcome of the other events was unknown. Patient did not receive any treatment for the events body aches, fever, nausea, headache and muscle weakness. Whereas therapeutic measure was taken as a result of "HR of 130/HR was 120". No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 55 | 2021-02-07 | nausea, vomiting |
Patient experienced nausea, vomiting and lightheadedness after receiving the Pfizer COVID vaccine on...
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Patient experienced nausea, vomiting and lightheadedness after receiving the Pfizer COVID vaccine on 2/6/21. She brought to the ED and given 4mg of Zofran and felt better after observation.
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| 55 | 2021-02-07 | indigestion, abdominal distension, diarrhea |
symptoms of COVID/ believes it could be COVID; symptoms of COVID/ believes it could be COVID; terrib...
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symptoms of COVID/ believes it could be COVID; symptoms of COVID/ believes it could be COVID; terrible diarrhea; constant headache; Gas; Bloating; Her arm was sore for 24 hours; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL8982, unknown expiration), via injection once to right arm on 14Jan2021 at a single dose as she is eligible with first tier for vaccination. Medical history and concomitant medications reported as none. The patient reported that she received the first dose of COVID vaccine on 14Jan2021 (Thursday). The next day (15Jan2021), her arm was sore for 24 hours after the shot, and she didn't have any side effects over the weekend. On 19Jan2021, Tuesday, she started having constant headache, and was experiencing problems with gas and bloating, it is very rare for her to have this issue, and it was building the last of couple days, she was uncomfortable and was taking over the counter medication for relief. She was keeping the headaches at bay with generic ibuprofen (lot: S200378, expiry: Mar2023), but if she missed a dose or is feeling better and doesn't take, it is coming back, it is consistent. Gas and bloating are primarily after eating, on Wednesday, after 24 hours it was ridiculous. She got some generic Extra Strength Gas Relief one tablet after eating (lot: 75257, expiry: Jun2022), and it was giving her some relief until early this morning. Tuesday, Wednesday, and Thursday, the gas and bloating was worse. Last night, her entire chest, she wanted to burp so bad, but couldn't because it really hurt, and it took a while for the next tablet to kick in and give relief, she was like where is this coming from, she didn't know it could build up so much. On 22Jan2021, she had a terrible diarrhea. Diarrhea was painful and intense, she took generic Pepto Bismol 1-2 tablets, and she took 4, The first time she woke up at 04:30 AM and at 7 another wave hit her, so she took another two tablets. Right now, she is feeling okay, but the gas is building up, her chest is filling, she is uncomfortable. The patient asked if these are reported side effects. She works in a dental office, and the doctor is knowledgeable and sensitive to COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, are these side effects or may she have COVID, though she doesn't know who she could have gotten COVID from. Out of protection for patients at dental clinic, the HCP at clinic wants her to get the COVID test as he believes it could be COVID and not side effect of the vaccine. She doesn't want to quarantine for nothing if it is just side effects of the vaccine. She will be getting rapid diagnostic for COVID and not the antibody test. She thinks she should get tested, but there is no testing appointment available until tomorrow, and she does not want to self-quarantine needlessly, she will live through it, she is happy to get the test, but she doesn't want to lose 2 weeks of pay if others are reporting the same side effects. She was happy to get the vaccine. The patient recovered from the event arm sore on 16Jan2021; not yet recovered from events constant headache, gas, and bloating; while unknown outcome for the remaining events.
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| 55 | 2021-02-09 | vomiting, nausea |
Bad headache; Nausea; Chills; Vomiting; This is a spontaneous report from a contactable consumer (pa...
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Bad headache; Nausea; Chills; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EL0140) at single dose on 16Jan2021 07:00 for Covid-19 immunisation, at healthcare facility where she worked (she worked in a kitchen, the hospital gave her the shot). The patient medical history and concomitant medications were not reported. The patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EK and maybe A or O, 231) at single dose 23Dec2020 5 o'clock for Covid-19 immunisation. On 21Jan2021 morning the patient woke up with really bad headache, vomiting and chills. She had first the major headache and then nausea, chills and then vomited. She thought side effects happen right away. No treatment in response to event received. On 21Jan2021 she went to work. She got the vaccine at work and then they tested her for COVID not positive in Jan2021. She also reported that on 21Jan2021 she took the COVID test and the results was unknown. The outcome of events was unknown. Information on Lot/batch number has been requested.
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| 55 | 2021-02-09 | vomiting, nausea |
Lot of tightness under my breast; Heart rate is elevated; Felt I wanted to vomit and then I vomited;...
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Lot of tightness under my breast; Heart rate is elevated; Felt I wanted to vomit and then I vomited; Felt I wanted to vomit and then I vomited; Chills; Had a bowel movement, it felt soft; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: not reported), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes, and acid reflux from an unknown date. Concomitant medication included hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) for hypertension, labetalol for hypertension, metformin for type 2 diabetes, and pantoprazole for acid reflux. It was reported that the patient took the shot on Friday, 22Jan2021 and everything was fine, felt fine. Today, 24Jan2021 the patient was requested to call because on Saturday, 23Jan2021, the patient woke up, and got herself something to eat. The patient took her medication as normal and may be about, after she ate a meal, took the medicine (unspecified medication), the patient felt she wanted to vomit and then she vomited, she felt chills. She immediately had a bowel movement, it was like soft. She just wanted to just lay down and she went on and she just went to work because she was thinking it is just a shot and it will subside but she did want to get to work and felt she cannot do it. She came home and this morning (24Jan2021) and just felt a lot of tightness under her breast. She did not know if it had anything to do with it? Her heart rate is elevated a little it is like 104 because she is hypertensive. The patient reported that she did not have treatment and was going to go and get an X-ray as to why she is feeling this tightness under her breast. The patient underwent lab tests and procedures which included heart rate: 104 (elevated) on 24Jan2021. The outcome of the events was unknown. Information on Lot/batch number has been requested.
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| 55 | 2021-02-16 | abdominal pain upper, nausea, abdominal discomfort |
Body aches, severe nausea, GI upset on 2-13-21 Next day still had severe nausea, GI issues, stomach ...
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Body aches, severe nausea, GI upset on 2-13-21 Next day still had severe nausea, GI issues, stomach pain 3rd day, still severely nauseated, frequent stools, pains in stomach even with sips of water. My stomach is still very sore, headache and nauseated, but getting better.
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| 55 | 2021-02-21 | vomiting, nausea |
Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm. Lasting a little...
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Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm. Lasting a little over 48 hours. Lymph nodes under left arm are still slightly swollen.
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| 55 | 2021-02-23 | vomiting, diarrhea |
At 10hrs I started having severe chills. 30 min-1hr later I had severe diarrhea and vomiting 1 time....
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At 10hrs I started having severe chills. 30 min-1hr later I had severe diarrhea and vomiting 1 time. Joint pain followed in ankles, knees, hips, elbows. Next day I had a severe headache with neck and mouth pain. Next day I was terribly weak.
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| 55 | 2021-02-23 | abdominal pain, nausea |
Near syncopal episode Diaphoretic, lightheaded, pale, nausea, abdominal pain Onset approx 09:45 am ,...
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Near syncopal episode Diaphoretic, lightheaded, pale, nausea, abdominal pain Onset approx 09:45 am , IV fluids administered, IV Ephedrine administered, EKG, telemetry monitor Taken to ER ,
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| 55 | 2021-02-24 | difficulty swallowing |
Five minutes after the vaccine was administered, my throat tightened and I was having difficulty swa...
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Five minutes after the vaccine was administered, my throat tightened and I was having difficulty swallowing. I took Benadryl and the symptoms minimized.
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| 55 | 2021-02-25 | difficulty swallowing |
Patient at 15 minutes post vaccination stated her heart was racing and had trouble swallowing. Patie...
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Patient at 15 minutes post vaccination stated her heart was racing and had trouble swallowing. Patient given Epinephrine 0.3 IM, Benadryl 50 MG IM, and Solumedrol 62.5 mg IM and then sent to ER.
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| 55 | 2021-02-26 | nausea |
The very next day and for the next three days I had over 103 fever bodyaches nauseous fatigue for ov...
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The very next day and for the next three days I had over 103 fever bodyaches nauseous fatigue for over a week and the arm I get the shot and did not feel better until a week later.
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| 55 | 2021-02-28 | vomiting, abdominal discomfort |
Headache Throwing up Stomach upset, only ate toast Sore arm Overall feeling lousy Could not go to...
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Headache Throwing up Stomach upset, only ate toast Sore arm Overall feeling lousy Could not go to work
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| 55 | 2021-02-28 | diarrhea, nausea |
Widespread body aches (especially in the injection arm and various joints), diarrhea, tiredness, nau...
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Widespread body aches (especially in the injection arm and various joints), diarrhea, tiredness, nausea, dizziness, shortness of breath, all starting on the evening of 2/27/21 and worsening 2/28 - 3/1 (at the submission of this report). Slight fever of 98.9 on 2/27 and 99.8 2/28 - 3/1.
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| 55 | 2021-03-02 | nausea |
Headaches; Chills/shivering; Nauseated; Body aches; This is a spontaneous report from a contactable ...
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Headaches; Chills/shivering; Nauseated; Body aches; This is a spontaneous report from a contactable consumer (patient) reported that a 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 11:00 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After dinner of 30Jan2021, the patient started having symptoms listed as headaches, chills, nauseated, and body aches. She described her chills as being so bad that she woke up last night shivering. She said the nausea and body aches come and go. She asked how long will her symptoms last. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 55 | 2021-03-03 | nausea, abdominal pain upper | Headache, stomachache, nausea. |
| 55 | 2021-03-04 | diarrhea, nausea |
March 2, 2021 (3days after injection) 12:30pm sudden onset of severe (incapacitating) dizziness, na...
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March 2, 2021 (3days after injection) 12:30pm sudden onset of severe (incapacitating) dizziness, nausea and headache. Loose stool. Fatigue. Muscle pain. Joint pain. Dry eyes. March 3 same as previous day with the addition of moderate kidney pain and extreme thirst. March 4:same as previous day with addition of severe migraine
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| 55 | 2021-03-04 | nausea | Nasusa, 100.4 fever, chills, body aches, fatigue |
| 55 | 2021-03-08 | nausea |
dizzy/Dizziness; nausea; This is a spontaneous report from a contactable Other Health Care Professio...
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dizzy/Dizziness; nausea; This is a spontaneous report from a contactable Other Health Care Professional, the patient. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), via an unspecified route of administration on 02Feb2021 at 07:00 (at the age of 55-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included COVID-19 infection on an unspecified date. The patient was not pregnant at the time of vaccination. Concomitant medications were reported as "No." The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021 at 06:00, the patient experienced dizziness and nausea. The reporter commented that she did not think these were side effects from the vaccine because she got it on Tuesday but her husband pointed out that she normally does not have these side effects, so it has to be from the vaccine. The clinical outcomes of the events dizziness and nausea were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 55 | 2021-03-10 | vomiting, diarrhea |
extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chil...
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extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chills; 1 hr later explosive diarrhea; vomiting; severe joint pain in ankles, knees, hips, elbows; severe headache; This is a spontaneous report from a contactable nurse report for self. A 55-year-old female (not pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular in left arm on 21Feb2021 10:45 AM at single dose for covid-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination. Concomitant medications in two weeks included atorvastatin, aspirin [acetylsalicylic acid], ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. Patient was allergy to morphine. Patient received first dose of bnt162b2 (lot number=EL9263) intramuscular in left arm on 30Jan2021 09:30 AM. On 21Feb2021, 1 hr later patient experienced explosive diarrhea and vomiting 1 time, severe joint pain in ankles, knees, hips, elbows, severe headache. 10 hrs after shot patient had severe chills. Next day joint pain in neck and mouth pain along with severe heart attack. On 23Feb2021 had extreme weakness. No treatment received. Patient was recovered from the events. Nasal Swab Covid test post vaccination on 22Feb2021 was Negative.; Sender's Comments: Based on the limited information provided it is unlikely that heart attack was related to suspect product in this patient on atorvastatin and aspirin. Case will be reassessed when additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-03-14 | nausea, abdominal discomfort |
diagnosed with COVID-19 disease/testing positive/sick/all the nightmares of COVID /felt very ill/COV...
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diagnosed with COVID-19 disease/testing positive/sick/all the nightmares of COVID /felt very ill/COVID took the 3 pounds off/fevers my eyes/body temperature kept dropping; diagnosed with COVID-19 disease/testing positive/sick/all the nightmares of COVID /felt very ill/COVID took the 3 pounds off/fevers my eyes/body temperature kept dropping; some fatigue/tired; stomach upset/stomach was really feeling weak; not feeling real well; nauseous; This is a spontaneous report from a contactable consumer reporting for self. This 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunisation. Medical history included menopause hormone replacement therapy. Concomitant medication included progesterone (PROGESTERONE), estradiol (MINIVELLE) for menopause hormone replacement therapy. The patient received her first injection of the Pfizer-BioNTech vaccine on 23Jan2021. She reported experiencing symptoms of COVID-19 on 09Feb2021 and was diagnosed with COVID-19 disease on 11Feb2021 after testing positive. After the first injection, and prior to getting COVID-19 disease, she did experience some fatigue, stomach upset, and not feeling real well. It was reported that when she had the first dose the only symptoms was stomach was really feeling weak, just felt extremely tired and nauseous so that was the first and then fine, by the third day she was feeling okay but then unfortunately, on 09Feb2021 and she began getting sick and went for a COVID test and tested positive on 11Feb2021. She had experienced multiple symptoms due to her COVID-19 disease and had to go to the ER for treatment after they appeared (she went to the emergency room so they didn't keep her there, she was there for maybe 6 hours). She felt very ill with this COVID, she had been in the hospital twice, she did not, she was not left in ICU that was good for her, but reported that "between the fevers my eyes, I don't know what happened to my eyes but ophthalmologist will be checking it seems to be same and it's been everything that you can ever think as 'hard' and I just want to know if tomorrow I can have the second boost." It was reported that when she was in the hospital because of the, body temperature kept dropping so the doctor send her to the hospital and they did blood test. Patient weight was 135 at that time, now she was 131. She thought COVID took the 3 pounds off. Her second dose of the Pfizer-BioNTech vaccine was cancelled due to her illness and now her second dose is scheduled for tomorrow (25Feb2021). The patient reported she is only now starting to feel a lot better, that she was really sick for 15 days. Today (24Feb2021) was the first day that she was feeling a little bit better from all the symptoms and all the nightmares of the COVID illness. The outcome of events was recovering.
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| 55 | 2021-03-17 | nausea |
Allergic reaction; injection site became swollen and indurated, excessive sweating in hands, red ras...
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Allergic reaction; injection site became swollen and indurated, excessive sweating in hands, red rash spots on both arms, dizziness, nausea, breathing difficulty. Result: Mild relieve of symptoms.
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| 55 | 2021-03-22 | nausea |
- Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors ...
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- Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors and ID team discussed risks of COVID vaccine and determined low risk due to no similar components between flu vaccine and COVID vaccine - Pt received first dose of COVID vaccine today (3/22/21) around 1230 - Within 10 minutes of injection, pt felt nauseous and was flush. She was given a drink and snack, monitored for 30 minutes, and felt better ? went back to work upstairs - 4 hours post injection (~1630) pt came to ED - itchy throat, hoarseness, urge to clear her throat, chest heaviness - In ED, pt has received methylprednisolone 125 mg, famotidine 20 mg, diphenhydramine 25 mg, duonebs, epinephrine 0.3 mg IM, and fluids with improvement. - Pt is being admitted for further monitoring
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| 55 | 2021-03-23 | nausea |
Day of shot developed pain in entire right side(chest area), also acid reflux and nausea. That went ...
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Day of shot developed pain in entire right side(chest area), also acid reflux and nausea. That went away about 12 hours after the vaccine. Ten days after I developed a slight pain in right lateral side that progresses to constant pain in 2 places on right side including under right clavicle. I had pain upon taking in a deep breath. Saw MD after 4 days of these SXS. Performed labs, Chest x-ray and EKG. All were essentially normal except elevated WBC count. Have 2 COVID test which were both normal. Md said possibly some sort of inflammation and suggested taking anti-inflammatories which did not help much at all with SXS. After a few more days the SXS changed to constant chest pain(pressure), SOB upon exertion and pain behind knee. F/U with MD again and it was decided to wait a few more days. Upon suggestion from friend asked MD to perform D-Dimer lab test. The result was 4,400. My normal value should have been 550. Sent to ER. CT of chest, EKG and more labs performed. CT revealed large bilateral pulmonary embolisms in pulmonary arteries. Started on blood thinners. Ultrasound of left leg revealed large DVT. Sent home after 2 days on blood thinners. SXS stopped after a few days.
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| 55 | 2021-03-25 | vomiting, abdominal discomfort |
Having all kinds of trouble in walking; sick on my stomach and was throwing up; sick on my stomach a...
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Having all kinds of trouble in walking; sick on my stomach and was throwing up; sick on my stomach and was throwing up; Pain; sick on my stomach and was throwing up; Headache; Hips, legs and neck is a little swelled; my hip down were pain; arm was very sore; could not move arm; arm was very sore; could not move arm; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received second dose of BNT162B2 (pfizer-biontech covid-19 vaccine, Formulation: solution for injection, lot number: EL3246; Expiration Date: 30Apr2021) via intramuscularly on right arm as single dose on 14Jan2021 for covid-19 immunisation. The patient received first dose on 24Dec2020 and she didn't have any reaction, no nothing. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient work at the hospital in the kitchen and don't have any health issues before, none. Laboratory data included, Multiple blood work, 3 MRIs, Chest X-ray, EKG, EMG. On 15Jan2021, after receiving second dose patient stated, it's been almost a month, she had all kinds of trouble, in walking, hips, legs and neck is a little swelled. she had a major headache the last four days, her arm was very sore, she was sick on her stomach, she was throwing up. The next day she could hardly walk. She used a walker. She was out of work and did physical therapy, from her hip down were pain and was hard to walk and it spend like that for a month now and it's now 17Feb2021. Patient hospitalized cause she couldn't walk. She spent six days in a hospital (28Jan2021 to 3Feb2021), they are not sure if it is related to that. They are not even sure what's going on. They can't tell what's wrong. Patient started the treatment with "Gabapentin-300 mg, twice a day, still taking, start date: Consumer stated, " she don't remember. Acetaminophen-codeine 3-1 tab every 6 hours as needed, still taking, start date: Consumer stated, "Last week, I don't know." She was just wondering why she had all these side effects. The outcome of the event she was sick on her stomach was unknown and all of the event was not recovered.
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| 55 | 2021-03-30 | diarrhea |
Patient received first dose of Pfizer COVID-19 vaccine on 3/22/21, the next day the patient reported...
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Patient received first dose of Pfizer COVID-19 vaccine on 3/22/21, the next day the patient reported feeling myalgia, diarrhea, and body aches and chills. The patient presented to the ED and was admitted with myocarditis and NSTEMI. Left heart cath did not show evidence of epicardial coronary artery disease. The patient was discharged from the hospital after receiving fluid resuscitation and supportive care. The patient returned to the ED with worsening myocarditis and was found to be in cardiogenic shock requiring vasopressor support. The patient developed VT storm and was intubated and sedated. The patient is currently in the ICU and remains intubated and sedated
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| 55 | 2021-04-01 | abdominal discomfort |
her stomach was bothering her; her daughter told her the right side of her tongue looked swollen; al...
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her stomach was bothering her; her daughter told her the right side of her tongue looked swollen; allergic reaction to the COVID-19 Vaccine; heaviness with her headache; stroke; Facial droop; Numbness / left half of her face was numb /numbness in her left hand/numbness and tingling all over her body; Tingling; Tiredness; Pain; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old adult female received the first dose of BNT162b2 (solution for injection; Lot EN6202 and expiry information not provided) via unspecified route in the left arm on 03Mar2021 between 17:10 and 17:30 (at 55-years-old) for COVID-19 immunisation. Relevant medical history included Frozen shoulder (2020-2020), and severe migraines (especially in the past ten years). The patient further stated that she has always had migraines. She said sometimes when her migraines escalate, her blood pressure goes up, and her left side tingles. She said several times in the past, she thought her migraine symptoms may have been a stroke. She said she her doctor is checking her for any kind of things like rheumatoid arthritis, mast cells, constant (chronic) fatigue, and fibromyalgia. She said right before the COVID-19 Virus pandemic she had passed out unexpectedly. She said she doesn't know what caused her to pass out. She said she needs another neurological test done. She said she had a neurological test that maybe showed that veins were dying in her brain, but she wasn't sure. She said her doctor had been doing heart tests too, but because of the pandemic, it was taking longer to have the tests done. The patient also mentioned that her last blood work was probably in/around Nov2020. There were no concomitant medications or past drug history reported. The patient denied receiving any other vaccination within the four weeks prior to the vaccination. The patient also denied receiving any other vaccination on the same date as the vaccination. The patient reported that on 04Mar2021, approximately seventeen hours after she received the COVID-19 vaccine, she had what she thought was a kind of severe reaction. She said she had an inside numbness and tingling all over her body. She said the left side of her body, especially, had a very strong numbness and tingling, like a stroke. She said the numbness was in her left hand, and outside left shoulder. She said the left half of her face was numb. She said at the time she felt weird. She said she was speaking to her friend on a video call and did not want her friend to think she was a cry baby. She said then her friend told her there was something happening with her face. She said the right side of her face had dropped. She said her right eye and the right side of her mouth were drooping. She said she told her friend she thought she had an allergic reaction to the COVID-19 Vaccine. She said it took about three hours for her symptoms to pass. She said afterward she was so tired, had pain, and a headache. She said it was strange for her to have a headache because she was used to migraines. She said she still had a headache today (08Mar2021). She said she had a heaviness with her headache. She said if she had a migraine, she would not be able to do anything, but with the headache she had, she was able to go about her everyday things. She said her stomach was bothering her too, but she was not worried about how her stomach felt. The events did not require any visits to a physician's office nor the emergency room. Treatment for the events included drinking a lot of water and moving around. The outcome of the events, inside numbness and tingling all over her body, very strong numbness and tingling, like a stroke¸ numbness was in her left hand, and outside left shoulder, half of her face was numb, right side of her face had dropped, and tongue looked swollen, and allergic reaction to the COVID-19 Vaccine was recovered on 04Mar2021 after about three hours duration. The outcome of the events so tired, and pain was recovered on an unspecified date in Mar2021. The outcome of the events, headache, and heaviness with her headache was not recovered.
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| 55 | 2021-04-03 | vomiting |
Right Ear fullness, constant ringing or noise. Hearing impaired in right ear, sounds muffled or som...
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Right Ear fullness, constant ringing or noise. Hearing impaired in right ear, sounds muffled or some noise is painful. This has been nonstop since 2-3 days after 1st vaccine. Have taken Claritin, pseudoephedrine as well as Benadryl to relieve the ear fullness, no relief.
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| 55 | 2021-04-06 | abdominal discomfort |
felt like there was a lot of pressure on her chest/heaviness in chest; congestion; Lip swelling; Ups...
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felt like there was a lot of pressure on her chest/heaviness in chest; congestion; Lip swelling; Upset stomach; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 13:00 (Lot Number: ER2613) as SINGLE DOSE for COVID-19 immunisation. Medical history included thyroid from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (TIROSINT) taken for thyroid, start and stop date were not reported. The patient previously took thiomersal and experienced allergy to thiomersal. On 22Mar2021, the patient had some reactions to BNT162B2, the patient was curious if she should take the second one, knowing how the patient's body. The patient waited for 30 minutes after the vaccine to make sure something didn't happen. The patient started to have lip swelling so she went back into the facility and waited a little longer, the swelling subsided on their own but then she started having shortness of breath through the evening, but not to the point to go to the emergency room. The patient felt like there was a lot of pressure on her chest, congestion and upset stomach. The main symptom was the heaviness in the chest. The outcome of congestion, lip swelling and upset stomach was recovering and the outcome of the rest of the events was unknown.
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| 55 | 2021-04-07 | vomiting |
Patient received vaccine on 3/29/21. Patient described rigors, fevers, and vommiting that started a...
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Patient received vaccine on 3/29/21. Patient described rigors, fevers, and vommiting that started about 24 hours after receiving the vaccine. These symptoms resolved by day three. However, she started developing parasthesias in her feet and pain in left hip. Patient came to hospital on 4/5 after symptoms worsened. In hospital, patient received an LP and GBS was ruled out and was discharged with patient still complaining of burning of her feet and hands.
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| 55 | 2021-04-09 | nausea |
must have fainted; severe nausea; This is a spontaneous report from a contactable consumer. A 55-ye...
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must have fainted; severe nausea; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered on right arm on 25Mar2021 14:00 (Batch/Lot Number: EW6204) at single dose (at the age of 55 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included estradiol, progesterone, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) and spironolactone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, on 04Mar2021 (Lot number: EN6198), 02:00 PM on the right arm. The patient stated on 26Mar2021, "woke up with severe nausea, went to restroom, must have fainted, because I came to with my face on the register vent". The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-04-15 | nausea |
fatigue from waist to feet posteriorly and bilaterally; gfr 47; headache; nausea; dizziness; facial ...
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fatigue from waist to feet posteriorly and bilaterally; gfr 47; headache; nausea; dizziness; facial tingling/bilateral hand and foot tingling; double vision; disorientation; joint pain; orthostatic hypotension; chills; photophobic/photophobia; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left deltoid on 26Jan2021 15:00 (Batch/Lot Number: EL1283) as single dose for covid-19 immunisation. The first dose was received on 05Jan2021 15:00 (lot number: EL1284) on the left arm. Medical history included herpes simplex virus (HSV), Superior Oblique Myokymia, and Lyme Disease; from an unspecified date and unknown if ongoing. Patient was not pregnant. Concomitant medications included calcium citrate, magnesium citrate (CAL/MAG CITRATE), ergocalciferol (VIT D), fish oil (OMEGA 3), and paracetamol (TYLENOL). The patient previously took VICODIN and flu vaccine as a child, and experienced allergies. The patient experienced headache, nausea, dizziness, facial tingling, double vision, disorientation, joint pain, orthostatic hypotension, chills, photophobic from 27Jan2021 05:00. On 02Feb2021, she experienced dizziness, headache, nausea, photophobia, facial tingling, bilateral hand and foot tingling, GFR 47 all other CBC, cmp normal. There was headache, nausea, photophobia, facial tingling on 07Feb2021 and on 10Feb2021, tingling and fatigue from waist to feet posteriorly and bilaterally. She had lab test drawn and blood work done when she was sick and her GFR came back as 47, so everything else was normal, and her GFR was 47 which was out of range. On 03Feb2021 was the first test and it was 2 weeks that she had to repeat test just to make sure it was back in normal range which it was. Thee patient was still experiencing the events but 'not as bad', and stated she can still function. Her side effects were improving but she still have a daily headache and paresthesia. The events resulted in physician/ healthcare professional visit. Patient was recovering from the events. ZOFRAN was given as treatment for the events. Patient stated she takes Tylenol but her doctor want her not to take medication for a while but she had to take Tylenol. Patient had no covid prior to vaccination and has been tested (nasal swab) post vaccination on 29Jan2021 with negative results.
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| 55 | 2021-04-18 | decreased appetite |
I then felt very fatigued & came down with w/a fever that night.; the headache was improved; I felt ...
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I then felt very fatigued & came down with w/a fever that night.; the headache was improved; I felt a lot of fatigue; a lot of arm pain; I felt some mild dizziness later in the day; irritable bowels throughout the day as well as a loss of appetite./My appetite is very much diminished; irritable bowels throughout the day as well as a loss of appetite.; I also started experiencing an odd ribcage/breast pain on the side of the injection (left side).; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (Patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EW0150), via an unspecified route of administration in the left arm on 02Apr2021 (age at time of vaccination: 55-years-old) at a single dose for COVID-19 immunization. Medical history included asthma, allergies to medications, food, or other products as Tree Nuts and NSAIDS. Concomitant medication patient received within 2 weeks of vaccination included zyrtec, vitamins C, Vitamin D, Vitamin E, Probiotic and Tylenol. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient experienced about 90 mins after 1 vaccine dose on 02Apr2021 at 04:00 PM, she developed a strong headache. The patient then felt very fatigued and came down with fever that night. The next day (yesterday), the headache was improved still present but she felt a lot of fatigue and a lot of arm pain. She felt some mild dizziness later in the day and irritable bowels throughout the day as well as a loss of appetite. On 02Apr2021, a day after 2 vaccine dose, she again felt fatigued with mild headache. her appetite was very much diminished with still irritable bowels. She also started experiencing an odd ribcage or breast pain on the side of the injection, it was felt like deep shooting pains. There was no pain or redness or swelling. she not breast issues to date (last mammography was clear-Fall 2018). Facility where the most recent COVID-19 vaccine was administered was Clinic. The event was considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal swab was unknown on 02Apr2021. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
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| 55 | 2021-04-21 | nausea |
Client states that 5 minutes post vaccination he began to feel swelling of the throat, dizziness and...
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Client states that 5 minutes post vaccination he began to feel swelling of the throat, dizziness and nausea. Observation area leads alerted by nurse and MD notified. Client evaluated by observation leads and given Benadryl 50 mg/1ml. Symptoms improved and client released by Dr.
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| 55 | 2021-04-24 | nausea |
minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips)...
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minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips); light headed/dizzy on day 2; exhaustion for four days; intense arm pain at injection site (pain began when shot was being given); slight nausea; This is spontaneous report from consumer (Patient) via (Pfizer/Bio-Tech). A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 03Mar2021 at 15:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation at hospital. Medical history included restless legs syndrome. The patient was not pregnant at the time of vaccination. Patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included carbidopa, levodopa (SINEMET), levothyroxine sodium (LEVOTHYROXIN). On an unspecified date in Mar2021, patient experienced minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips), exhaustion for four days, intense arm pain at injection site (pain began when shot was being given), slight nausea, lightheaded/dizzy on day 2. It was unknown whether patient treatment for the adverse events. Outcome for the events were unknown. Information for lot/batch number has been requested
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| 55 | 2021-04-28 | abdominal pain |
rectal bleeding; colitis; abdominal pain; UTI; This is a spontaneous report from a contactable consu...
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rectal bleeding; colitis; abdominal pain; UTI; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 10:30 at the age of 55-years-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included known allergies. There were concomitant medications in two weeks. The historical vaccine included 1st of BNT162B2 on 10Mar2021 09:30 am at left arm for COVID-19 Immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe abdominal pain and rectal bleeding 4 days after the shot (05Apr2021 00:30) and on the 4th day went to emergency room had multiple tests done including but not limited to bloodwork and urine work up and CT scan, finding colitis, rectal bleeding and urinary tract infection (UTI). Therapeutic measures were taken as a result of events. The events outcome was unknown. No COVID 19 diagnosed prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. Information about the Lot/batch number has been requested.
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| 56 | 2020-12-31 | nausea |
Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then m...
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Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then mild headache for 24 hrs. No symptoms after 24 hrs except sore arm for 2 days.
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| 56 | 2020-12-31 | nausea |
patient had dizziness, headache and nausea. bp was 127/89 HR 87. Patient was evaluated by a doctor t...
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patient had dizziness, headache and nausea. bp was 127/89 HR 87. Patient was evaluated by a doctor that was working vaccination clinic. instructed to take tylenol. No further intervention required.
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| 56 | 2020-12-31 | diarrhea, abdominal discomfort |
upset stomach , diarrhea , muscle pain, soreness & stiffness at site of injection in left arm upset...
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upset stomach , diarrhea , muscle pain, soreness & stiffness at site of injection in left arm upset stomach started around 11:00am & went away after having bowel movement, it returned again around 2:00pm & again went away after bowel movement, it returned for a third time around 3:00pm & that is when the diarrhea occurred. That was the last time of any signs or symptoms. I drank 2 cups of ginger tea afterwards which seem to help settle my stomach. The muscle pain, soreness & stiffness in left arm at injection site started at bedtime around 9:00pm on the day of receiving vaccine & still continues today but is improving
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| 56 | 2021-01-03 | decreased appetite |
Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appe...
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Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appetite I had a hard time sleeping. I just took Tylenol.
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| 56 | 2021-01-03 | diarrhea |
Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. ...
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Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. On day 2, patient experienced shills, diarrhea, headache, weakness that lasted 3.5 days. Reports follow-up with primary physician.
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| 56 | 2021-01-03 | abdominal pain |
They have my injection listed as Moderna which is a mistake. The Manufacturer is Pfizer. On the 23rd...
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They have my injection listed as Moderna which is a mistake. The Manufacturer is Pfizer. On the 23rd. I went into anaphalactic shock admitted to the ER, given an epinephrine drip, I was given iv bolises, chest xray, vitals were taken and blood was drawn. ABGs and chest xray and lactic acid tests were administered. I have to carry a epi pen and need to see a pulmonologist, I have triggers now where I need an emergency inhalor and was put on a course of steroids and my heartbeat is 20 beats higher than usual. I was really tired and having abdominal pain .
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| 56 | 2021-01-04 | nausea, vomiting |
Nausea; Dizziness; vomited once; Chills/her left hand, where she got the shot, it does not feel righ...
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Nausea; Dizziness; vomited once; Chills/her left hand, where she got the shot, it does not feel right. It feels chilled.; soreness and pain at the vaccine site; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via intramuscular on left top upper arm where the muscles are below shoulder on 24Dec2020 at single dose for prevention because she works in hospital (COVID-19 immunisation). The patient medical history included high blood pressure. Concomitant medication included Hydrochlorothiazide started a year ago in 2019 at 12.5mg, once daily for High blood pressure. A later response of symptoms including nausea, dizziness, and vomited once. The patient got the COVID vaccine last Thursday, 24Dec2020. That day she had chills on 25Dec2020 06:00. (PENDING CLARIFICATION) She did not have any more problems with that. The second day, 25Dec2020 00:00 she had soreness and pain at the vaccine site. Then, it was ok but sore that day and then this morning. She is having dizziness, nausea and vomited one time at 07:30 on 29Dec2020. Started on 10:00 25Dec2020, her left hand, where she got the shot, it does not feel right. It feels chilled. On Monday, she was completely fine. She did not leave. At work on Sunday. No discomfort. Today morning, she has chills and started getting all the symptoms. Her left hand is not normal. She cannot say it is weak though. The left hand is chilled. She would like to know if Pfizer has reports of others with similar issues. She also would like to know if she should get the second dose and if she should see a physician about any of these. She works at the hospital and they were giving out to employees. There was no prescriber. It was not mandatory. Her daughter got it on 20Dec2020. She is a doctor and did not have any issues. Lots of people in her family got the vaccine. No further details provided. Regarding the first day she got chills, it was like an all over body chill. The chill described on her left hand went away on 25Dec2020, and today is feeling it again. Left hand is not bad cold, just chilly. She was still tired. She is not dizzy but didn't feel all that good. Outcome was provided as persisting but improved. She was tired the day she got the vaccine at night time on 24Dec2020, she went to bed early, slept all night and Friday morning she was also tired. By Friday afternoon, she felt better and was doing better until this morning and it started again. She did not feel this bad when she got the vaccine. Today, it is worse. She is nauseated, dizzy and tired. She never had a flu vaccine. This is the first time in her life getting a vaccine. The outcome of the events chills and left arm sore and painful was recovering and the outcome of the other events was unknown.
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| 56 | 2021-01-04 | nausea |
Pfizer-BioNTech COVID-19 Vaccine Patient received COVID-19 vaccine on 12/30/2020 at 7:21am and abou...
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Pfizer-BioNTech COVID-19 Vaccine Patient received COVID-19 vaccine on 12/30/2020 at 7:21am and about 3 minutes later, experienced nausea, dizziness and weakness. Patient was brought to ED to be evaluated @ 07:35 am. Ondansetron 4mg inj was given at 8:29am and NS 1000 mL was given over 2 hrs at 8:30am. Patient felt better and tolerating oral at 09:19 am and discharged at 9:25am.
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| 56 | 2021-01-04 | vomiting, nausea | Vertigo, nausea, vomiting |
| 56 | 2021-01-05 | nausea, abdominal pain upper | Extreme vertigo, stomach pain then nausea |
| 56 | 2021-01-05 | nausea |
Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade ...
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Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; This is a spontaneous report from a contactable nurse. A 56-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKS730), intramuscularly on 20Dec2020 08:45AM at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Patient was diagnosed with COVID-19 prior to vaccination. Known allergies included Penicillin. Concomitant medication included levothyroxine, pravastatin, buspirone, zinc, ascorbic acid (VITAMIN C), tocopherol (VITAMIN E), vitamin d3, vitamin b complex (B COMPLEX), calcium citrate, chondroitin sulfate, glucosamine sulfate, methylsulfonylmethane (GLUCOSAMINE CHONDROITIN & MSM). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash on 20Dec2020. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The patient underwent Covid test type post vaccination - Nasal Swab: Negative on 23Dec2020.
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| 56 | 2021-01-05 | abdominal pain |
started spotting this morning; low back pain mild; breast tenderness; abdominal pain mild; The initi...
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started spotting this morning; low back pain mild; breast tenderness; abdominal pain mild; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 30Dec2020 this case now contains all required information to be considered valid. A contactable nurse (patient) reported a 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EH9899), intramuscular on the left deltoid on 17Dec2020 at SINGLE DOSE for COVID-19 vaccination at the hospital, estradiol (ESTRADIOL gel), oral from May2020 and ongoing at 1 mg, 1x/day for menopause and progesterone (PROGESTERONE tablet), oral from May2020 and ongoing at 100 mg, 1x/day for menopausal symptoms. Medical history included blood pressure issues since 2000 and ongoing. The patient was also menopausal (ongoing). Concomitant medication included losartan (LOSARTAN) for blood pressure issues. On 28Dec2020, the patient experienced abdominal pain mild. She also had low back pain mild and breast tenderness noted on 29Dec2020. The patient also stated that she felt like she was going to have a period even she has not had a period in 3 years as she was on progesterone and estradiol. The patient will see doctor to make sure that it was not anything. On 30Dec2020, the patient reported that she started spotting this morning. The patient did not receive any treatments for the events. The action taken in response for progesterone and estradiol as dose not change. The patient recovered from abdominal pain mild on 28Dec2020; low back pain mild and breast tenderness on 29Dec2020. Stated that the spotting resolved at noon on 30Dec2020. The reporter considered the events as non-serious. The reporter also considered that the events were related to Pfizer BioNTech Vaccine while unrelated to estradiol and progesterone.
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| 56 | 2021-01-06 | nausea |
2 hours, after receiving injection, started feeling nausea, slight headache, very slight sore arm; ...
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2 hours, after receiving injection, started feeling nausea, slight headache, very slight sore arm; 3-4 hours later took 3 ibuprofen due to the headache. Feeling light headedness. Next morning, sore arm was heavy, headache, body aches, temp 99, and nausea; felt unwell; took 3 ibuprofen. Time off from work to just lay flat and rest for the day.
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| 56 | 2021-01-06 | nausea |
C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported "chest tw...
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C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported "chest twinge". Radial pulse measured 88- pulse felt weak. Brought over to EMS for evaluation, monitor shows HR 87, BP 185/98 (160/88 manual), O2 99% on RA. HR came down to 79, BP 142/80. Around 0910 c/o nausea and dizziness. 0915 called daughter to drive her home, refused to transfer with EMT to hospital.
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| 56 | 2021-01-06 | diarrhea, vomiting, nausea | Diarrhea & NauseaVomiting Narrative: |
| 56 | 2021-01-06 | nausea |
Patient complained of dizziness, wheezing, cough, and nausea. BP 180/110, P 72, O2 saturation 99% R...
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Patient complained of dizziness, wheezing, cough, and nausea. BP 180/110, P 72, O2 saturation 99% RA; 3:23PM BP 180-110, P 84, O2 sat 99% RA; 3:35PM BP 210/100 P88, O2 sat 98% -- > called emergency services; 4:25PM BP 140/92. Paramedics administered 1 dose 25mg diphenhydramine.
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| 56 | 2021-01-06 | nausea |
Patient was feeling nauseous after the vaccination. Went and ate lunch. When she came back from lunc...
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Patient was feeling nauseous after the vaccination. Went and ate lunch. When she came back from lunch, she passed out and a code blue was called. She never lost a pulse, but when in the ER she could not speak. She responded to commands without speaking. About 30 minutes later, she finally spoke.
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| 56 | 2021-01-07 | diarrhea, nausea, vomiting | Chills, fever, nausea, vomitting, diarrhea, and body aches |
| 56 | 2021-01-07 | nausea | Fever 102.9, chills, body aches, pain at injection site, nausea, cough |
| 56 | 2021-01-07 | nausea |
I became ache all over, fever of 100.7. Severe headache and nausea. That has past and now, can not t...
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I became ache all over, fever of 100.7. Severe headache and nausea. That has past and now, can not taste and smell and congested.
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| 56 | 2021-01-07 | nausea |
Patient C/O palpations, hot, dizzy, slightly nauseated. No SOB Patient observed x 40 minutes B/...
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Patient C/O palpations, hot, dizzy, slightly nauseated. No SOB Patient observed x 40 minutes B/P 126/86 HR 76 Sat 96% Patient did elect to call her husband to pick her up
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| 56 | 2021-01-07 | nausea, vomiting |
upon presentation for second dose, patient informed us that last time she was dizzy and we had her s...
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upon presentation for second dose, patient informed us that last time she was dizzy and we had her sit for 30 minutes . Upon further conversation she mentioned that she was dizzy when walking to her car the first time (12/17/2021) . She said the first time she felt dizzy walking to her car and vomited, then laid in her car for an hour before being able to drive home. Didn't eat much that night. Received second dose today 1/8/2021. She was feeling dizzy and nauseated less than 10 minutes from injection. at 11;05 a.m. blood pressure was 139/66; 11:15 a.m. 126/71 at approximately 11:35 a.m. 139/73. MOved her with wheelchair from vaccination room to patient room on a bed. Applied 92 per nasal canula. Physician in room (not privy to exam) Zofran 4mg Sublingual given and transported via wheel chair to other side side of hospital to ER
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| 56 | 2021-01-08 | nausea |
Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, l...
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Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, left arm weakness/numbness, skin itching. BP checked and was 190/110, then 180/110. Hx HTN and BP meds taken today. Hx of allergies -- took loratadine and hydroxyzine this AM. Due to the dizziness and skin itching, feeling unwell/woozy with history of anaphylaxis, given epipen and called 911. EMS arrived and taken to ER.
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| 56 | 2021-01-08 | diarrhea, abdominal pain |
Lower abdominal cramping followed by diarrhea lasting for 2 days; then lower abdominal cramping foll...
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Lower abdominal cramping followed by diarrhea lasting for 2 days; then lower abdominal cramping followed by loose non-watery stools lasting for an additional 5 days.
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| 56 | 2021-01-08 | nausea |
Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later ...
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Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later Tylenol taken Next day painful injection site, body aches chills fatigue Tylenol Advil taken with some relief
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| 56 | 2021-01-08 | vomiting | Severe vertigo, vomiting for 12 hours. Vertigo for 5 days. Out of work for 5 days. |
| 56 | 2021-01-09 | nausea |
1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, ...
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1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, total body/muscle/joint aches, migraine headache, nausea, heart palpitations, as well as very sore, swollen arm. Had to spend the day in bed. Most symptoms relieved by the next 24 hours except arm pain and fatigue. 2nd vaccine: Similar, but worse symptoms developed approximately 12 hours after vaccine. All of the aforementioned symptoms, but fever of 101.4 and arm wasn't quite as sore. As above, had to spend a day in bed.
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| 56 | 2021-01-09 | nausea |
Mild pain/soreness at injection site starting later the day of injection and next day. Approximately...
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Mild pain/soreness at injection site starting later the day of injection and next day. Approximately 2 pm the day after injection, began feeling overly hot and nauseated. That was followed by pressure type headache, muscle/bodyaches, and overall feeling of no energy progressing as the afternoon and evening continued. Spent that evening sleeping on/off. The following day spent in bed with continued headache, body/muscle aches, feeling overall drained/ no energy. Nausea improved some; was able to stomach some soup later in the day. So far today, feeling some improvement with bodyaches, but overall drained of energy. Headache has lightened some as well.
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| 56 | 2021-01-09 | nausea, vomiting | Very fatigues, headache, nausea, intermittent chills, vomited once. |
| 56 | 2021-01-10 | nausea |
3 hours post vaccine- severe nausea. Lasted for 29 hours 3 hours post vaccine. Left arm pain-mild, l...
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3 hours post vaccine- severe nausea. Lasted for 29 hours 3 hours post vaccine. Left arm pain-mild, less than flu shot pain. lasted 3 days. 6 hours post vaccine- bad headace-lasted 29 hours 8 hours post vaccine-mild chills. Lasted 5 minutes 10 hours post vaccine- another episode of chills-lasted 10 minutes 12 hours post vaccine-moderate tiredness. Lasted 24 hours 12 hours post vaccine-generalized achiness-lasted 24 hours
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| 56 | 2021-01-10 | abdominal pain upper | Extreme Fatigue and a few days after the shot, stomach pain (cramplike but not cramps) |
| 56 | 2021-01-10 | vomiting, nausea | Pfizer Bio NTech COVID 19 vaccine EUA- symptoms began 01/06/21 chills, fever, HA, body aches, N&V |
| 56 | 2021-01-10 | nausea |
Pt to report to the RN on the morning of 01/11/2021 that since she received the second dose of the P...
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Pt to report to the RN on the morning of 01/11/2021 that since she received the second dose of the Pfizer vaccine (COVID-10) that she had had disturbing nightmares. Pt reports that she had two night-mares after the 1st dose, but said the second dose she started having nightmares this morning. Pt declined evaluation at the clinic after reporting of the events. Other S/S she had experienced are headache, nausea, chills, weakness, feeling tired but symptoms have improved.
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| 56 | 2021-01-10 | nausea |
Pt with complaints of disturbing nightmares since administration of the COVID-19 vaccine. Pt reports...
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Pt with complaints of disturbing nightmares since administration of the COVID-19 vaccine. Pt reports on 01/11/2021 to this RN that she had a couple nightmares after the first injection. Pt reports that she had two nightmares after the first dose. Since her second dose was received on January 8, 2021 she reports having disturbing night mares and requested reporting of the events. Pt declined evaluation at the clinic after notification of the event. Pt voiced she will follow-up with her PCP if the nightmares continue. Other side effects she reported with the second dose is nausea, tiredness, fatigue, headache, chills and some weakness. Those symptoms have since improved.
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| 56 | 2021-01-10 | nausea |
Severe headache, Fever 100.9F, Dizzy, Nausea, Heart Palpitations, Head congestion, severe fatigue. A...
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Severe headache, Fever 100.9F, Dizzy, Nausea, Heart Palpitations, Head congestion, severe fatigue. All lasting approximately 12 hours.
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| 56 | 2021-01-10 | nausea |
feeling flushed elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta ...
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feeling flushed elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta at 5:36 patient reported to be feeling better - drank water - declined transport to ER - felt able/safe to drive home
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| 56 | 2021-01-11 | nausea |
Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hou...
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Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hours after injection. 5 days after injection; chills and major lower back pain.
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| 56 | 2021-01-11 | nausea |
Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling wit...
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Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling within 10 hours after injection. 5 days after injection resulted in massive lower back pain and chills.
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| 56 | 2021-01-11 | nausea, vomiting |
Receive first dose vaccine 12/18/20. On 12/24/20 awakened with vertigo/nausea/vomitting. Self treat...
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Receive first dose vaccine 12/18/20. On 12/24/20 awakened with vertigo/nausea/vomitting. Self treated (as had similar 4 years earlier) with Epley maneuver, rest. Symptoms gradually improved over 2 dayes. Received 2nd dose 1/8/21. Awakened early 1/12/21 with vertigo, nausea, vomitting. Again it is improving with self treatment but contacted UConn vaccine call center who suggested I file this.
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| 56 | 2021-01-11 | nausea | sudden onset nausea, malaise, fatigue, later that day developed eye swelling |
| 56 | 2021-01-12 | nausea |
1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain towar...
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1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain toward the kidney, stomach area. Felt like she would pass out. Dizzy, nausea. Seeing a patient she had to leave the room and go sit on the floor. Blood pressure was very low, couldn't stand up. Painful to have clothes touching the skin all over. Felt like she need more air, panting. Didn't sleep 8-10 hours. Started with sever H/A and muscle pain. Sensitive to light and sound. Fatigue. Out of work 1/12-1/13. Skin sensitivity is gone. Talk big dose of ibuprofen. Still fatigue. H/A is better.
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| 56 | 2021-01-12 | nausea, diarrhea, diarrhea, nausea |
16 hrs post 2nd COVID vaccination injection I experienced the following symptoms: severe aches and p...
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16 hrs post 2nd COVID vaccination injection I experienced the following symptoms: severe aches and pains in joints, chills-cold hands,feet, lethargy, slight nausea, diarrhea. Symptoms subsided over the following 24 hours. Joint aches continue
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| 56 | 2021-01-12 | nausea | Body aches, fever, chills, headache, nausea, sore throat, left ear pain, COVID exposure w/in 14 days |
| 56 | 2021-01-12 | diarrhea | Congestion, loss of taste/smell, diarrhea, ear pain, eye irritation |
| 56 | 2021-01-12 | nausea |
Fever; Chills; Fatigue; Body Aches; Headache; Nausea; Other vaccine same date; Other vaccine same da...
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Fever; Chills; Fatigue; Body Aches; Headache; Nausea; Other vaccine same date; Other vaccine same date; This is a spontaneous report from a contactable other health professional (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 12:00 PM at single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were none. On the 06Jan2021, other vaccine was vaccinated on the same date at left arm. On 07Jan2021 09:00, patient experienced fever, chills, fatigue, body aches, headache, nausea. Treatment of events "fever, chills, fatigue, body aches, headache, nausea" was unknown. Outcome of "Other vaccine same date" was unknown, while outcome of other events was recovering. Information on the lot/batch number has been requested.
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| 56 | 2021-01-12 | nausea |
Mild arm soreness started within 6 hrs of administration of vaccine. Within 12-16 hours of adminis...
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Mild arm soreness started within 6 hrs of administration of vaccine. Within 12-16 hours of administration patient developed intermittent chills, fever 101.4 to 102.2 F , moderate to severe tension headache, mild muscle ache/joint pain, insomnia, severe fatigue, and mild nauseau. Fever lasted for approximately 48 hours. Other signs and symptoms resolved by 72 hours following vaccination. Patient also noticed mild fatigue as well as slight disorientation and slight loss of balance until 1/11/21. Patient was normal by 1/12/21. No specific treatments administered.
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| 56 | 2021-01-12 | retching, nausea |
Received the vaccine at 330p. Began to have mild upper eyelid itching around 11:59p. Eyes felt sw...
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Received the vaccine at 330p. Began to have mild upper eyelid itching around 11:59p. Eyes felt swollen then began to feel nauseous (tried to vomit, but no food came up) and then a runny nose (clear fluid). I took another Claritin 10mg and also Zofran 8mg ODT which resolved the nausea. Had to blow my nose 2 times. Went to sleep with my Epipen at bedside but didnt have to use it. Woke up at 815am and only symptom remaining was arm soreness. Felt like my normal self and played 3 hrs of tennis. Arm soreness at injection site worsened during the day. By 72 hrs post-injection, arm soreness resolved.
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| 56 | 2021-01-13 | abdominal pain upper, nausea | Nausea stomach cramping |
| 56 | 2021-01-13 | nausea, nausea | Systemic: Nausea |
| 56 | 2021-01-13 | nausea |
Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck ...
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Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck and arm
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| 56 | 2021-01-13 | nausea |
patient was extremely dizzy and nauseous after receiving vaccine. stated room was spinning. after 15...
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patient was extremely dizzy and nauseous after receiving vaccine. stated room was spinning. after 15 minutes and having a glass of water she felt better
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| 56 | 2021-01-14 | diarrhea, abdominal pain |
Abdominal cramping; watery diarrhea; loose stools; This is a spontaneous report from a contactable n...
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Abdominal cramping; watery diarrhea; loose stools; This is a spontaneous report from a contactable nurse reporting for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK5730/expiration date: not provided), via intramuscular route of administration, on 21Dec2020 01:30 PM (at the age of 56 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history included rosacea. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not provided. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Dec2020, the patient experienced abdominal cramping followed by watery diarrhea for 2-3 days. Then on an unspecified date in Dec2020, the patient experienced abdominal cramping followed by non-watery loose stools for 4-5 days. The patient did not receive any treatment for these events. The outcome of the events abdominal cramping, watery diarrhea and non-watery loose stools was recovered on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19.
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| 56 | 2021-01-14 | abdominal discomfort | Fever chills fatigue arm pain upset stomach bradycardia |
| 56 | 2021-01-14 | nausea |
Vaccine received on 1/7/21. Joint pain, nausea, gastric reflux started on 1/9/21. Generalized hives ...
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Vaccine received on 1/7/21. Joint pain, nausea, gastric reflux started on 1/9/21. Generalized hives started on 1/11/21. Symptoms improved with Zofran, Pepcid and Benadryl. Symptoms resolved on 1/15/21. Patient had a history of COVID 19 virus infection in October 2020.
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| 56 | 2021-01-14 | nausea | dizziness, headache, nausea, "puffy thoat", BP 123/59, O2 sat 100%, HR 70 |
| 56 | 2021-01-15 | nausea |
vertigo-type dizziness, especially severe in the morning; queasiness (may be related to the dizzines...
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vertigo-type dizziness, especially severe in the morning; queasiness (may be related to the dizziness); a heightened sense of taste, sensitivity to light, and increased startle reaction to sudden sounds
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| 56 | 2021-01-16 | nausea |
12/16/2020 First vaccination. 12/17/2020 rash began. Nausea. 12/18/2020 rash over all extremities....
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12/16/2020 First vaccination. 12/17/2020 rash began. Nausea. 12/18/2020 rash over all extremities. Lasted until 12/22/2020. Nausea. called clinic on 12/21/2020 to report the rash. I tend to get rashes with different aspirin, cough medication, etc. PCP advised to take benadryl if happens again to control rash if occurs. I did take as the rash came back, took for one day, and the rash was gone the next day. 2nd vaccine EL3246
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| 56 | 2021-01-16 | nausea |
12/16/2020 vaccine 12/17/2020 rash began, Nausea 12/18/2020 Rash covered all extremities; called cli...
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12/16/2020 vaccine 12/17/2020 rash began, Nausea 12/18/2020 Rash covered all extremities; called clinic that tuesday to report. Advised to take benadryl 2nd shot for rash. EL3246. Rash did occur. Went away after one day.
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| 56 | 2021-01-16 | vomiting, nausea |
I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lighthead...
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I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lightheadedness and nausea upon awakening Saturday morning. Saturday night was having increased nausea and lightheadedness. Got up to use the bathroom at 1 AM Sunday morning was very dizzy and nauseous and passed out on my hallway floor. I woke choking on vomit, crawled to the bathroom, continued to vomit. Sustained bruised lump to forehead, bruised nose, split lips. Went back to bed. Later Sunday felt better.
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| 56 | 2021-01-17 | abdominal discomfort |
Symptoms began approximately 7 hours after receiving the vaccine and continued throughout the follow...
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Symptoms began approximately 7 hours after receiving the vaccine and continued throughout the following day. The first symptoms were ear and sinus pressure. Then malaise/fatigue, headache, mild stomach upset. Fever occurred in the middle of the night and got up to 101.1. Also developed shakes/tremors and severe back and body aches. My arm was sore at site of injection.
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| 56 | 2021-01-18 | nausea | Jan. 6, 7, & 8 - Had chills, fever, nausea, dizziness, headache, sore throat, ear pain, & fatigue |
| 56 | 2021-01-19 | nausea |
At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling naus...
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At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling nauseated almost threw up, also felt drunk (balance, lack of clear thinking, a little weak, etc). That lasted from about 8 hours after the shot (when it started) to 20 hours after the shot was administered.
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| 56 | 2021-01-19 | nausea |
From the evening of the day I have received the vaccination, my left arm started to feel dull contin...
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From the evening of the day I have received the vaccination, my left arm started to feel dull continuous pressure pain, progressed stronger and stronger as the time goes. No treatment given. Following day, the pain was worse and stayed same. The IM insertion site was also painful to touch or pressure. Then afternoon of the same day, I started nausea, light headache, dizziness, and occasionally chills as well as occasional dry cough accompanied by itchy throat or without itchy throat. At this point, I took Advil 200mg 1 tab around 3pm. The muscle pain on my left arm and headache is eased but other symptoms stayed same at this time, 4:30pm.
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| 56 | 2021-01-19 | nausea | PATIENT REPORTS TINGLING IN HANDS, NAUSEA, AND SWEATING WITH THE FIRST DOSE |
| 56 | 2021-01-19 | nausea | Patient reports tingling in hands, nausea, and sweating with the first dose. |
| 56 | 2021-01-19 | abdominal pain |
Severe, painful abdominal cramping, sweating, and pooping. Felt like childbirth. So painful it was d...
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Severe, painful abdominal cramping, sweating, and pooping. Felt like childbirth. So painful it was difficult to hold back tears or regulated my breathing. A lot like a severe "spastic colon attack". 2 1/2 hrs later, a dozen or so toilet flushed and it's not over with yet!
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| 56 | 2021-01-19 | decreased appetite | fever extensive muscle and bone pains headache soreness at injection site lack of appetite chills |
| 56 | 2021-01-19 | abdominal discomfort | sore arm, gastric upset, tirednessn/a |
| 56 | 2021-01-20 | vomiting, nausea | 1/7/21 cough, fever, N/V, HA, congestion |
| 56 | 2021-01-20 | nausea, vomiting | Severe fatigue, fever, chills, nausea, vomiting one time, head ache, eyes burning |
| 56 | 2021-01-20 | decreased appetite | chills, sore arm, heart racing loss of appetite |
| 56 | 2021-01-20 | nausea |
moderate tiredness; generalized achiness; mild chills/another episode of chills; Bad headache; sever...
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moderate tiredness; generalized achiness; mild chills/another episode of chills; Bad headache; severe nausea; Left arm pain-mild, less than flu shot pain; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received bnt162b2 (COVID 19, Pfizer, lot number: EL3246), via an unspecified route of administration on the left arm on 08Jan2021 16:45 at a single dose for an COVID-19 immunisation. Medical history included impaired gastroparesis, pancreatitis, hashimoto's thyroiditis, allergies: sulfa and adhesives. The patient's concomitant medications were not reported. The patient has known allergies with pethidine hydrochloride (DEMEROL). The patient is not pregnant. The patient has no COVID prior vaccination and was not COVID tested post vaccination. On 08Jan2021 at 19:45 (3 hours post vaccine), the patient experienced severe nausea that lasted for 29 hours; and left arm pain-mild, less than flu shot pain that lasted 3 days. At 22:45 (6 hours post vaccine), the patient had a bad headache that lasted 29 hours. On 09Jan2021 at 00:45 (8 hours post vaccine), the patient experienced mild chills that lasted 5 minutes, then 02:45 (10 hours post vaccine) another episode of chills that lasted 10 minutes. On 09Jan2021 at 04:45 (12 hours post vaccine), the patient experienced moderate tiredness and generalized achiness that lasted 24 hours. The patient recovered from severe nausea on 10Jan2021 00:45 and bad headache on 10Jan2021 03:45, recovered from left arm pain-mild, less than flu shot pain on 11Jan2021, recovered from chills on 09Jan2021 00:50, and recovered from moderate tiredness and generalized achiness on 10Jan2021 04:45.
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| 56 | 2021-01-21 | vomiting | Chills, couldn?t get warm! Whole body couldn?t stop shaking, Pounding headache, Fever, & Vomiting. |
| 56 | 2021-01-21 | difficulty swallowing | Flushing, dizziness, throat tightening, difficulty swallowing |
| 56 | 2021-01-21 | nausea |
Received 1st Covid vaccine on 12/30/2020 and did not have any problems. Received 2nd Covid vaccine ...
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Received 1st Covid vaccine on 12/30/2020 and did not have any problems. Received 2nd Covid vaccine at 08:30 about 22:00 that night, started getting moderate headache, moderate nausea, mild joint pain, gassy and moderate reflux. 5 days later, I still have mild -moderate headache and mild-moderate nausea.
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| 56 | 2021-01-21 | nausea |
Shortly after received her vaccine she had developed a fever, dry cough, sore throat, body aches, ea...
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Shortly after received her vaccine she had developed a fever, dry cough, sore throat, body aches, ear ache, nausea for one day, headache, and shortness of breath with coughing and stairs. She had a telemedicine appointment with her MD office and they recommended her not to work and to use her inhaler and some cough medicine.
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| 56 | 2021-01-24 | decreased appetite |
2 hrs after vaccine began to feel chills, did not have good appetite and didn't eat lunch. Started f...
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2 hrs after vaccine began to feel chills, did not have good appetite and didn't eat lunch. Started feeling lightheaded 3 hrs post vaccine. Able to stay at work until 4pm, went home, felt lightheaded, ate a meal and felt somewhat better. Got up around 9:30pm, was on feet for a couple of minutes, went to kitchen and reached for a plate on top of the refrigerator. Had presyncopal aura, then fainted. Apparently fell on buttocks, which are sore. No other symptoms. Constitutional symptoms have resolved. Evaluated in ED today.
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| 56 | 2021-01-24 | nausea |
significant dissociation; developed hot flashes in sternum; anxiety; dizziness and light headedness;...
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significant dissociation; developed hot flashes in sternum; anxiety; dizziness and light headedness; muscle weakness/lower leg feel shaky and weak and tingly; depersonalization; shakey/lower leg feel shaky and weak and tingly; mild nausea; arm pain; The caller would touch her hand but couldn't feel her hands, it was like they weren't hers; lower leg feel shaky and weak and tingly; hand on that same side was painful, but not unbearable, just uncomfortable; emotional; tearful; felt completely overwhelmed; This is a spontaneous report from a contactable consumer. A 56-Year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route at left upper arm on 12Jan2021 about 9:15am at single dose for COVID-19 immunization. Vaccination facility type was hospital. Medical history and concomitant drugs were not reported. Weight: 175-180 lbs. No additional vaccines administered on same date of the Pfizer suspect vaccine. No prior vaccinations within 4 weeks. Past drug included rivaroxaban (XARELTO) been using the product more than 10 years and never had a problem with it, she didn't think that was related to her experience. Patient received first vaccine yesterday 12Jan2021. 45 minutes after receiving vaccine (12Jan2021 10 AM), she developed hot flashes in sternum (flushing sensation in her sternum or upper chest area. It was like when she had a dye injected), anxiety, dizziness/ light headedness, muscle weakness, significant dissociation, depersonalization, shakey, mild nausea, arm pain. The patient explained that this was why she was in the MRI scanner (Jan2021). This came a couple of times yesterday and had not been experienced this today (13Jan2021). It (dizziness) was ongoing and sporadic and had happened couple times yesterday and today. There were a few hours yesterday 12Jan2021 where she felt like herself but then it all started again last night. The patient reported feeling disassociated from her body, this was within about 20 minutes of the flushing and went in and out of being more or less alarming. She stated she felt disconnecting from where she was and space she was in, mentally. She knew where she was but could feel no connection to where she was or her body. The patient would touch her hand but couldn't feel her hands, it was like they weren't hers. This was during the half hour of the events occurring. She had mild nausea, this started not long after the flushing and it came and went a little bit but it was not too troublesome. The patient felt disconnect from her body and had shakiness like her lower leg feel shaky and weak and tingly. This happened on and off since the episodes started. The patient reported she slept great and had a few hours yesterday where she felt good. Her arm was tender, this might have been yesterday but she thought it was this morning and was only tender to touch. The hand on that same side was painful, but not unbearable, just uncomfortable. The patient apologized for being emotional and tearful. She felt completely overwhelmed. She couldn't believe that she put herself in this position and she was perfectly fine before the shot. She did contact her doctor. No AE required a visit to emergency room/ physician office. There had been no treatment, she didn't know what to do. She remarked she was not going back for the second dose. Outcome of event dizziness was not recovered, and the rest of events was unknown.
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| 56 | 2021-01-25 | abdominal pain, nausea |
Dizziness; nausea; headache; abdominal pain; body aches; This is a spontaneous report from a contact...
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Dizziness; nausea; headache; abdominal pain; body aches; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BEL-3246), intramuscular in left arm on 10Jan2021 11:00 at SINGLE DOSE for COVID-19 immunization. Medical history included allergies to blue dye from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Versed, Parafon Forte and experienced allergies. On 10Jan2021 11:30 AM, the patient experienced dizziness, nausea, headache almost immediately followed by abdominal pain and body aches within 6 hours. No treatment given for the events. The patient recovered from the events on unspecified date. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19.
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| 56 | 2021-01-25 | nausea |
Runny nose; Left arm is hurting; Severe headache; Nausea; Pain all over, can hardly move; Pain all o...
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Runny nose; Left arm is hurting; Severe headache; Nausea; Pain all over, can hardly move; Pain all over, can hardly move; This is a spontaneous report from a contactable consumer reported for self. This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via unspecified route of administration on 12Jan2021 between 13:30 and 14:00 at single dose in left arm for COVID-19 immunization. Patient worked in EVS. The patient medical history included rheumatoid, asthma, artery disease, gastroparesis. There is no family medical history. The patient concomitant mediations not provided. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 22Dec2020 at single dose in left arm for COVID-19 immunization. The patient had a headache with the first dose of bnt162b2 and a little bit of chest pain (stated she had heart troubles) (AER 2021050910). The patient experienced severe headache, nausea, and pain all over, can hardly move from 12Jan2021. Pain all over, can hardly move started at the night of 12Jan2021. It hurts so bad. The patient also experienced runny nose and left arm is hurting from unspecified date. There is no relevant tests. The outcome of events severe headache, nausea, and pain all over, can hardly move was not resolved. Nausea and pain all over, can hardly move was reported as worsened. The outcome of others event was not reported. Information about lot/batch number has been requested.
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| 56 | 2021-01-25 | nausea |
little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense ...
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little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense of smell; decreased sense of taste; everything she eat or drinks has a metallic taste to it; muscle stiffness; Fatigue; arm soreness/right arm was still tender to touch/The first shot hurt way more and hurt all over the whole arm, it was throbbing; sinus pressure and congestion; sinus pressure and congestion; felt really lightheaded; low grade headache; chest feeling tight/chest tightness; she is not feeling good; wheeze; cough; This is a spontaneous report from a contactable nurse (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular (IM) in right deltoid on 07Jan2021 15:30 at second single dose for preventative. The patient medical history was not reported. There were no concomitant medications. The patient previously took H1N1 flut shot in 2015 or 2016 for immunisation and experienced muscle stiffness and fatigue, first dose bnt162b2, via IM in left deltoid for preventative on 18Dec2020 at 18:00 and patient was tender in her left arm, the first shot hurt way more and hurt all over the whole arm, it was throbbing. No additional vaccines administered on same date of the pfizer suspect. No prior other vaccinations administered within 4 weeks. The patient took the second dose of the Pfizer Covid vaccine on Thursday 07Jan2021 at 15:30. She called employee health and was advised to call Pfizer to report side effects since she is not feeling good. She had never had the covid diagnosis. On Friday (08Jan2021) she worked all day and felt arm soreness and sinus congestion but nothing out of the ordinary. The patient reported her right arm was still tender to touch, if she rotated her arm she can feel that she had the shot and she was still tender in her left arm from the first shot. The first shot hurt way more and hurt all over the whole arm, it was throbbing. On 08Jan2021 evening she felt really lightheaded, she thought maybe it was her sinuses since it is dry due to winter. She felt like a truck hit her. She had a low grade headache. On 09Jan2021, she felt a little nauseous, queasy, no vomiting. On Saturday (09Jan2021) she had a low grade temp of 100.3 degrees F. She had the chills and shakes on Saturday and most of yesterday. She got up today (reported on 12Jan2020) at 5:30 am, she checked her temperature and it was 97.2 after the shower, an hour later it was 98 degrees F. She felt like she had to keep clearing her throat, her chest felt a bit tight which started Friday evening, the chest tightness was not terrible but it was there. She was not wheezing but when she took a deep breath she felt a little like a wheeze and she had to cough, she had a scratchy throat on 09Jan2020. She stayed home from work yesterday. The patient did not feel lightheaded today, felt it yesterday and did not notice it at all this morning, reported it has resolved. The sinus pressure and congestion started Friday night, she felt stuffy. She had a decreased sense of smell and taste on 09Jan2021. Unless something is right in front of her, she could not smell anything. She felt quite nauseous this morning but at the moment her nausea is under control. She had a decreased sense of taste, everything she ate or drunk had a metallic taste to it, on 09Jan2021. She felt that all the side effects mentioned were related to getting the vaccine. On 08Jan2021, she also experienced muscle stiffness and fatigue which had improved after a hot shower, that helped. She felt like she had a bad flu shot. The only time she ever felt similar to this was when she received the H1N1 flut shot in 2015 or 2016. She did not have lot number, NDC, or expiration date to provide. Treatment included: took Tylenol on Saturday. The events did not require a visit to emergency room and physician office (she is trying to get an appointment to see the doctor). Outcome of the event lightheaded was recovered on 12Jan2021, of events low grade headache, chest tightness, scratchy throat, sinus pressure and congestion, decreased sense of smell, decreased sense of taste, everything she eat or drinks has a metallic taste to it, arm soreness was not recovered, of events chills and shakes, muscle stiffness, fatigue was recovering, of other events was unknown. Information about Lot/Batch has been requested.
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| 56 | 2021-01-26 | vomiting, nausea | Aches, nausea vomiting and Fever |
| 56 | 2021-01-27 | nausea, diarrhea, abdominal pain |
1/26/2021 to 1/27/2021 Body aches, nausea, diarrhea, abdominal cramping, 1/28/2021 mild facial ed...
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1/26/2021 to 1/27/2021 Body aches, nausea, diarrhea, abdominal cramping, 1/28/2021 mild facial edema/periorbital & upper lip
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| 56 | 2021-01-27 | decreased appetite |
Body aches, slight fever, no appetite, very fatigued from 6 am to 8 pm , 16 hours after receiving my...
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Body aches, slight fever, no appetite, very fatigued from 6 am to 8 pm , 16 hours after receiving my 2nd dose of the Pfizer vaccine. Took Advil every 4 hours. All symptoms gone next morning.
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| 56 | 2021-01-27 | diarrhea |
Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female ...
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Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number EJ1686) , via an unspecified route of administration on 13Jan2021 09:30 at single dose on left arm for covid-19 immunization . Medical history included breast cancer (hence tamoxifen) , prediabetic. Concomitant medication included tamoxifen for breast cancer, calcium, vitamin d nos. The patient experienced diarrhea on 13Jan2021 11:30. The patient stated that, "started diarrhea within 2 hours after the vaccination, stopped 10 hrs later. I had a toast with peanut butter and hot water 1 hr before the shot (which is something I eat every morning) I skipped lunch and dinner. Just drank water until the diarrhea stopped around 10pm. I had the same thing next morning without issue." No treatment was received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Case assessed as non-serious. The outcome of the event was resolved on 13Jan2021 22:00.
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| 56 | 2021-01-27 | nausea |
Face, neck, arms turned bright red; Face extremely swollen; Nausea; This is a spontaneous report fro...
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Face, neck, arms turned bright red; Face extremely swollen; Nausea; This is a spontaneous report from a contactable healthcare professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), intramuscular (left arm) on 12Jan2021 10:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included lamotrigine. The patient experienced Face, neck, arms turned bright red, Face extremely swollen, Nausea; all on 12Jan2021 10:45 AM. The outcome of the events was recovering.
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| 56 | 2021-01-27 | vomiting, nausea |
On Sunday, 1/17/21, patient was nauseous and vomiting and could not keep anything down at one point ...
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On Sunday, 1/17/21, patient was nauseous and vomiting and could not keep anything down at one point vomit was dark in appearance. Patient receives home dialysis when nurse came to home on Monday, 1/18, saw condition of patient and sent them to the hospital. At the hospital it was noted she had redness throughout body, no hives or blisters. Patient was lethargic, received antiemetic and medication for rash, does not know what medications were. On Tuesday, 1/19, she received 2 liter transfusion, discharged on Thursday, 1/21. Today, Thursday 1/28 patient still feels lethargic and states rash is peeling.
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| 56 | 2021-01-27 | nausea |
metal taste, flushing, palpitations, dizziness, nausea, headache 9pm arm sorness, severe aches, chil...
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metal taste, flushing, palpitations, dizziness, nausea, headache 9pm arm sorness, severe aches, chills weakness, fatigue the next day aches, weakness and fatigue headache continued for 5 days fatigue and headache continues daily
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| 56 | 2021-01-28 | nausea, abdominal pain |
12 hours post vaccine, chills and fever, headache, full body aches, abdominal pain and nausea. Se...
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12 hours post vaccine, chills and fever, headache, full body aches, abdominal pain and nausea. Severe symptoms lasted 36 hours, same symptoms but less severe lasted 72 hours. Now Friday, no fever or body aches, abdomen still sore. But feeling better
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| 56 | 2021-01-28 | nausea |
dizzy; headache; nausea; puffy throat; This is a spontaneous report from a contactable pharmacist. A...
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dizzy; headache; nausea; puffy throat; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3249), intramuscular at Arm Left on 12Jan2021 at the 56 years old at single dose for COVID-19 immunization. The medical history included bronchitis and palpitations. The concomitant medications were not reported. The patient experienced dizzy, headache, nausea, "puffy throat" all on 12Jan2021. There was treatment received for events dizzy, headache, nausea, "puffy throat". The patient underwent lab tests and procedures, which included Blood pressure (BP) 123/59, O2 Saturation 100%, Heart Rate70 all on an unknown date. The outcome of all the events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.
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| 56 | 2021-01-29 | nausea, diarrhea | Headache fatigue chill fever nausea diarrhea lymph node swelling. Pain itchiness |
| 56 | 2021-01-29 | nausea | headache, nausea, fatigue |
| 56 | 2021-01-31 | nausea, decreased appetite |
Shortness of breath,chills,hot sweating. Later that night legs aching like a toothache all night sha...
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Shortness of breath,chills,hot sweating. Later that night legs aching like a toothache all night sharp shooting pain in left shoulder couldn't sleep. Next day chills nausea aching legs migraine. Couldn't eat. Still having problems with legs.
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| 56 | 2021-01-31 | nausea | after second dose feel like mild flu and body aches, light headache and little nusia |
| 56 | 2021-02-01 | nausea, abdominal pain |
sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; se...
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sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; severe abdominal pain; Nausea; Injection site pain; This is a spontaneous report from contactable other hcps (including patient herself). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid19, lot number EL3248) , via an unspecified route of administration 08Jan2021 17:30 at single dose on left deltoid for covid-19 immunisation. Medical history included covid-19 the first time in Oct2020 to an unknown date , then from 16Nov2020 to an unknown date and experienced "every symptom except for vomiting". The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 18Dec2020 for covid-19 immunisation and experienced neck hurting, Shingrix Vaccine on 04Dec2020 for immunization and experienced no adverse effect. The patient experienced severe abdominal pain, nausea, Injection site pain on 12Jan2021, headache, fatigue, feeling of total lack of energy on 13Jan2021, fever on 16Jan2021. She had severe abdominal pain and nausea for three days (as reported). The caller stated she took Zofran for her nausea. The caller stated she had a rapid COVID-19 Virus test that was negative, but continued to feel queasy. She stated she had 100.5-101.8 degree fevers over the weekend, and has been sleeping a lot. Reported she woke at 4:00AM on Tuesday, 12Jan2021, with severe abdominal pain. She said the abdominal pain is better but not completely gone. Abdominal Pain Treatment: Declined any. Reported she hasn't discussed with her doctor the adverse events she has been experiencing since receiving the second COVID-19 Vaccine dose. She stated she had injection site pain for 2-3 days after receiving the second COVID-19 Vaccine dose. She said she didn't have any injection site soreness with the first COVID-19 Vaccine dose. She said she thought she was good after receiving the second COVID-19 Vaccine dose, but then on Tuesday, 12Jan2021, she woke at 4:00AM with severe abdominal pain. She said the abdominal pain came in waves. She described the abdominal pain as an 8 out of 10, clarifying the abdominal pain would be sharp and then fade away, and then the abdominal pain would cycle back around. She said she found herself standing over her toilet a few times because the abdominal pain was so severe, she thought she was going to throw-up. She clarified she had nausea and took and old prescription of Zofran she had received for vertigo years ago. She stated she did not have the Zofran NDC, Lot, and Expiration Date. Reported her abdominal pain and nausea went away by Thursday, 14Jan2021, saying the abdominal pain and nausea was less and less each day. She clarified the abdominal pain and nausea were intermittent, saying all of a sudden she would not feel good. She said her nausea has been better for the past 2-3 days. She clarified she called off work on Tuesday, 12Jan2021, and on Wednesday, 13Jan2021, she had a Rapid COVID-19 Virus Test before she started work that day (13Jan2021) to make sure that she wasn't positive for the COVID-19 Virus. She said she had a headache, no energy, and felt fatigued at work on Wednesday (13Jan2021), and Thursday (14Jan2021), but didn't take her temperature during that time. She said she didn't work on Friday (15Jan2021), but continued to have the headache, fatigue, and feeling like she had no energy. She said she didn't check her temperature until Saturday, 16Jan2021. She said she woke up Saturday (16Jan2021) at 9:40AM and went back to sleep until 11:30AM. She said she woke back up at 1:42PM and her husband told her she felt hot to the touch. She said she checked her temperature and it was 101.8 degrees. She said she checked her temperature first thing this morning (18Jan2021) because she could tell she sweated overnight, and her temperature was 100.3. She said she just checked her temperature again, and her temperature was now 99.3 degrees. She said by this afternoon, her temperature will be in the 101 range. Headache & Fever Treatment: Reported she took Naproxen (clarified as a prescription Naproxen 500mg tablet), and Tylenol (clarified as Equate brand Acetaminophen 500mg tablet) for her headache and fever on Saturday (16Jan2021). She said she took the Naproxen and Acetaminophen 500mg once in the morning, and again at night, before bed. She stated she did not take any Naproxen or Acetaminophen on Sunday, 17Jan2021. Acetaminophen 500mg tablet (Equate Brand): UPC Number: Unknown, Lot Number: 0HV1335, Expiration Date: May2022 Naproxen 500mg tablet (Prescription dispensed in round, pharmacy bottle): No NDC, Lot, or Expiration Date Reported she had another COVID-19 Virus test performed on Sunday, 17Jan2021, at 11:40AM at a drive-thru test site at Pharmacy. She clarified it was a "send-out" PCR COVID-19 Virus test, and she had not received her test results yet. She said her belly doesn't hurt anymore. She said she doesn't have a gallbladder and appendix. She said if she had the flu, the flu lasts for 3-5 days, and she is not coughing. She said she feels like now, what she felt like when she had the COVID-19 Virus the first time in Oct2020. She said she had a 12 days of severe fatigue when she had COVID-19 in Oct2020. She said her COVID-19 Virus symptoms started on 14Oct2020 with nasal congestion, and by 16Oct2020 she couldn't taste her yogurt. She said she got tested later in the day on 16Oct2020 for the COVID-19 Virus. She clarified she definitely had no sense of smell or taste on Friday, 16Oct2020. She said on Thursday, 15Oct2020, she kept falling asleep in the evening, saying that never happens. She said on Friday, 16Oct2020, she had a fever of 100.3, as well. The outcome of the events severe abdominal pain, nausea was resolved on 14Jan2021, of Injection site pain was resolved on an unspecified date, of sleeping a lot and she sweated overnight was unknown, of other events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of abdominal pain, nausea and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-02-03 | diarrhea, vomiting |
In the beginning I didn't have any issues, I was fine. I went to bed and woke up at 2am and started ...
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In the beginning I didn't have any issues, I was fine. I went to bed and woke up at 2am and started vomiting like I never before and had diarrhea , a fever of 101.3. My fever dropped in three hours back to normal which was weird. It was strange. The diarrhea lasted for days, it was uncontrollable . The vomiting lasted for three days, it was non-stop. I had this headache that was unbelievable . Since having Covid I get headaches daily. I had Covid in March 2020. I lost 4lbs in three days and I called my Dr. He said You need to go the ER right now. I went to the ER and had to wait three hours, I had aches and pain like the flu, I was totally out of it. They did a Cat scan, and blood work was normal. They gave me IV fluids, IV Tylenol and Tramadol. They did a Covid and flu test, both were negative. Then they gave me a shot of Fetanal , that took away my headache for 30 minutes. At this point I didn't have any more vomiting or diarrhea . I stayed about 8 hours in the ER and went home. I was told by my Dr. not to get the next shot.
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| 56 | 2021-02-03 | nausea, vomiting | Nausea, vomiting, fever, chills, headache |
| 56 | 2021-02-03 | nausea, abdominal pain upper |
severe stomach pains; bad headache; dizzy; Didn't have any energy and strength; Cold sweats; Nauseou...
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severe stomach pains; bad headache; dizzy; Didn't have any energy and strength; Cold sweats; Nauseous; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 20Jan2021 at 02:45 PM as a single dose for COVID-19 immunisation, lot number: EL3247. Medical history included chronic lyme disease. Concomitant medications were not provided. Patient had no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 23Jan2021 at 12:00 AM patient had severe stomach pains with a bad headache. Shortly after she got dizzy, did not have any energy and strength. She had cold sweats. Patient tried sips of water, but it made her nauseous. This all happened all at once and it hit patient hard in the middle of her work. No treatment received for the events. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events.
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| 56 | 2021-02-05 | nausea |
56-year-old female presents via video visit today for symptoms that started after her second Covid v...
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56-year-old female presents via video visit today for symptoms that started after her second Covid vaccine on January 29. Patient states that she started developing headache 1 week ago now with extreme fatigue, chills, body weakness and nausea. Patient has no congestion, cough, fever, soreness, vomiting or diarrhea. She was doing fine the first few days after the vaccine but today symptoms worsen with new onset of nausea, weakness. She has been drinking turmeric tea. Has not been taking any NSAIDs. She feels "winded" even doing a load of laundry. She also reacted to the first dose of vaccine with a prolonged headache.
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| 56 | 2021-02-07 | vomiting, nausea, abdominal discomfort |
Post vaccine day 1 (after 2nd dose) Was at work, began feeling very poorly in the late afternoon - w...
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Post vaccine day 1 (after 2nd dose) Was at work, began feeling very poorly in the late afternoon - went home & went to bed, slept through night and had sweats on and off. Post vaccine day 2- Fatigue, abdominal discomfort and pressure, constipated. Nausea and vomiting developed, with dehydration. Constipated, symptoms consistent with Crohn's flare. Went to ER but due to long wait was not seen by physician. Gradually improved, saw GI specialist day 4, felt much better by day 6. Bowels not quite back to normal 2 weeks later
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| 56 | 2021-02-07 | nausea, decreased appetite |
Received both vaccines on 1/14/21 and 2/4/21. On 2/4/21 went to ICC with complaints of fatigue, loss...
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Received both vaccines on 1/14/21 and 2/4/21. On 2/4/21 went to ICC with complaints of fatigue, loss of appetite, body aches, chills, nausea, headache, sore throat, and nasal drainage x3 days. Diagnosed with Acute viral syndrome
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| 56 | 2021-02-09 | abdominal pain |
Hot painful red rash on abdominal area; Hot painful red rash on abdominal area; welts; swelling; Thi...
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Hot painful red rash on abdominal area; Hot painful red rash on abdominal area; welts; swelling; This is a spontaneous report from a contactable other hcp. A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration at single dose left arm on 23Jan2021 11:15 for covid-19 immunisation. Medical history included thyroid disorder, breast cancer female, migraine, allergy to sulfonamide and topamax, food allergy. Concomitant medications included levothyroxine, liothyronine (NP THYROID), multivitamin, plant based calci. The patient experienced hot painful red rash on abdominal area on 23Jan2021 18:00, welts on 23Jan2021 18:00, swelling on 23Jan2021 18:00. No treatment received. The outcome was not recovered. Information on the lot/batch number has been requested
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| 56 | 2021-02-09 | diarrhea, nausea |
diarrhea; I still don't feel quite well; i felt almost like a mild fever; light headed; little nause...
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diarrhea; I still don't feel quite well; i felt almost like a mild fever; light headed; little nauseated; quite chilled; had nausea that worsened when lying down and felt like i was drunk (balance/coordination, clarity of thought); had nausea that worsened when lying down and felt like i was drunk (balance/coordination, clarity of thought); This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3246/expiration date: unknown), via unknown route of administration, on 19Jan2021 03:30 PM (at the age of 56 years old) as a single dose on left arm for COVID-19 immunisation for COVID-19 immunisation at a hospital. Relevant medical history included hypothyroid, hypertension, celiac, chronic dermatitis. The patient allergic to statins, gluten-intolerant (celiac). The patient was not pregnant at time of vaccination. Relevant concomitant medications included Levothyroxine, Irbesartin, Vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that on 19Jan2021 10:30 PM, about 7 hours after the shot and for the next 12 hours, she was quite chilled, had nausea that worsened when lying down and felt like she was drunk (balance/coordination, clarity of thought). After 12 hours of those symptoms, the drunk feeling and nausea were gone but she has since then struggled with diarrhea if she eats anything not completely bland, including today (4 days later). She stated "I still don't feel quite well and if I am very active (like she was packing boxes last night), I felt almost like a mild fever, light headed and a little nauseated." The outcome of the events chills, nausea, feeling drunk was recovered after 12 hrs later. The outcome of events diarrhea, don't feel quite well, fever, light headed and nauseated was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.
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| 56 | 2021-02-09 | decreased appetite |
rash on my elbow; loss of appetite; tired; dizzy; This is a spontaneous report from a contactable co...
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rash on my elbow; loss of appetite; tired; dizzy; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021 10:00 on Arm left at single dose (Lot # EL3246) for covid-19 immunisation. No medical history and concomitant therapy. She woke feeling dizzy on 24Jan2021, went to bed feeling dizzy and woke up feeling dizzy and the feeling isn't going away and she has a rash on her elbow on 25Jan2021. She took an antihistamine for it. She took the (Pharmacy name) off brand antihistamine. She does not know the name of it. She doesn't have an appetite on 25Jan2021. She doesn't feel sick but she usually loves her breakfast. She also maybe is a little tired on 25Jan2021. She also reports that her second vaccine dose is due today and feeling like this she doesn't know if she should get it. Outcome of the event dizzy was not recovered. Outcome of other events was unknown.
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| 56 | 2021-02-09 | decreased appetite, nausea |
vertigo/dizziness; vertigo/dizziness; Chills; body aches; extreme tiredness; bilateral ear pain; nau...
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vertigo/dizziness; vertigo/dizziness; Chills; body aches; extreme tiredness; bilateral ear pain; nausea; No appetite; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at let arm on 19Jan2021 17:00 at single dose for covid-19 immunization. The patient was not pregnant. The COVID-19 vaccine was administered at Hospital. The patient medical history reported as none. Concomitant medication included cimicifuga racemosa (BLACK COHOSH), curcuma longa (TURMERIC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 on 29Dec2020 07:00 at left arm for covid-19 immunization. The patient experienced Chills, body aches, extreme tiredness (slept for 30+ hours), bilateral ear pain, nausea - this all started 15 hours after 2nd dose on 20Jan2021 08:00, and then vertigo/dizziness started 4 days after 2nd dose on 23Jan2021, and also experienced no appetite from an unknown date in Jan2021. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 56 | 2021-02-09 | decreased appetite |
within first 24 hours: headache, loss of appetite. within 36 hours: increased headache (moderate-sev...
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within first 24 hours: headache, loss of appetite. within 36 hours: increased headache (moderate-severe), fatigue, loss of appetite. within 72 hours symptoms subsided
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| 56 | 2021-02-20 | vomiting, decreased appetite, nausea |
Fever, Severe chills, Muscle weakness and aches, lethargy, metallic taste, loss of appetite, nausea,...
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Fever, Severe chills, Muscle weakness and aches, lethargy, metallic taste, loss of appetite, nausea, vomiting
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| 56 | 2021-02-21 | nausea |
After first COVID-19 vaccine, patient experiencing prolonged fatigue, joint and muscle pains, headac...
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After first COVID-19 vaccine, patient experiencing prolonged fatigue, joint and muscle pains, headache and nausea. Symptoms have lessened over the course of 3 weeks, but are still present. Patient has about 2/3 the normal physical function, and feels to be working at about 1/2 of their normal working capacity. The patient followed up via phone call the COVID-19 nursing line, COVID test taken, negative, and was advised supportive care and acetaminophen if needed.
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| 56 | 2021-02-21 | nausea |
After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water o...
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After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water only since the night before and no food. I stayed about 1/2 hour, no one could say if this happens, About 12:30 or 1pm I wanted to sleep and slept 4 hours. The next dayi experience sensitivity to light sound headache nausea dizzy and ringing in the ears. I had to take off work at 12:30 and every since then I have had a headache after trying to work only a few hours. I couldn't keep my head set on, cant talk or train because the headaches are too bad. My doctor prescribed Imitrex. The Imitrex didn't even tough the headache, it just made me tired.
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| 56 | 2021-02-21 | retching, nausea |
Pt received injection, first dose. of Pfizer vaccine at 10:27am. Pt was taken to observation stati...
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Pt received injection, first dose. of Pfizer vaccine at 10:27am. Pt was taken to observation station in mall area of hospital for 15 minute observation, by another nurse.. At approx. 10:32, when observing nurse questioned pt about any headache, nausea, vomiting or other reactions, , pt c/o headache, then dizziness, nausea and ultimately started attempting to vomit, having "dry heaves" only. This nurse calls Code RRT to location of event.. Pt was taken to ER via stretcher.
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| 56 | 2021-02-23 | nausea |
severe soreness at the injection site; soreness at the injection site was so severe that she was una...
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severe soreness at the injection site; soreness at the injection site was so severe that she was unable to sleep or lift her arm; soreness at the injection site was so severe that she was unable to sleep or lift her arm; Chills; mild headache; Nausea; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EC324U), via an unspecified route of administration on 11Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included penicillin allergy. Concomitant medications included unspecified daily vitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via intramuscular on an unspecified date at 12:00 pm at 56- years of age on the left arm for COVID-19 immunization and had only mild muscle soreness at injection site. The patient was not diagnosed with COVID-19 prior to vaccination. On 11Jan2021, at eight hours post injection, the patient experienced severe soreness at the injection site. The patient stated that the soreness at the injection site was so severe that she was unable to sleep or lift her arm. On the same day, the patient also had chills, mild headache and nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event mild headache was not recovered while the other events was recovered on an unspecified date in Jan2021.
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| 56 | 2021-02-23 | nausea |
sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft pala...
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sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; scratchy throat on eating red meat, milk, or cheese; muscle and joint pain; earache; pain was all over; muscle and joint pain; headache; exhaustion; pain at injection site; slight fever; mild nausea; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264), on right arm via an unknown route of administration on 03Feb2021 13:45 for COVID-19 immunization. Medical history included VonWillebrand's and history of lyme disease. The patient had allergy to peanut and allergy to latex. Concomitant medications included unspecified vitamin supplements. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302) on Left arm, on 13Jan2021 13:30 for COVID-19 immunization. Patient stated, "After first shot in left arm, only on her left side she had: Muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered. Second shot in right arm: Same as above (muscle and joint pain, earache, headache, exhaustion, and pain at injection site), although no eye drainage and pain was all over with slight fever, mild nausea in Feb2021. Lasted from 12 hours to 36 hours after the test. Arm remained sore longer, but not problematic. Bizarre possible response: 6 days after second shot on 09Feb2021 17:30, the patient experienced sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes, scratchy throat on eating red meat, milk, or cheese. Patient did not need epi-pen but needed double dose of benadryl. Events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Benadryl and epi-pen on hand was received as treatment for events. The events were assessed as non-serious by the reporter. Outcome of events muscle and joint pain, earache, headache, exhaustion, pain at injection site, pain was all over, slight fever, mild nausea was recovered in Feb2021, whereas outcome for other events was reported as unknown. No follow-up attempts are possible. No further information is expected.
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| 56 | 2021-02-24 | nausea, diarrhea, abdominal pain upper | Fatigue, nausea, headache, diarrhea, stomach pain |
| 56 | 2021-02-24 | nausea | Nausea; Headache; low grade fever |
| 56 | 2021-02-26 | nausea |
Motion sickness, mild. Slight headache, slight nausea, increased mucus production while in moving ve...
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Motion sickness, mild. Slight headache, slight nausea, increased mucus production while in moving vehicle. Overall tiredness. Treatment : increased fluid intake, staying home.
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| 56 | 2021-02-28 | nausea |
I started running a fever couple a hours,dizziness, nausea that lasted to around 12:00 pm. I missed ...
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I started running a fever couple a hours,dizziness, nausea that lasted to around 12:00 pm. I missed a day of work dint feel safe driving.
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| 56 | 2021-02-28 | difficulty swallowing |
Pt described a difficulty swallowing, slight swelling, and a brief time of altered mental status abo...
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Pt described a difficulty swallowing, slight swelling, and a brief time of altered mental status about 30 minutes after vaccine administration. Pt was able to calm down and described a slight alleviation in symptoms. Pt denied hx of anaphylaxis. Medics were dispatched to the location to transport. No medications given by health department or EMS on scene.
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| 56 | 2021-02-28 | nausea |
Sinus pain congestion; Sinus pain congestion; coughing; tiredness; headaches; chills; muscle pain; f...
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Sinus pain congestion; Sinus pain congestion; coughing; tiredness; headaches; chills; muscle pain; feeling unwell; back pain; achy all over; very dizzy; nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318 and expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included High BP, diverticulosis, vertigo and blood clot in artery (healing), allergy to red licorice, hayfever dogs and cats. Patient was not pregnant at the time of vaccination. Concomitant medication included doxycycline, aspirin [acetylsalicylic acid], Multi vit, fiber gummy, and BP meds. There was no other vaccine in four weeks. The patient previously took hydrocodone and prednisone, and experienced allergies. The patient experienced sinus pain and congestion, coughing, tiredness, headaches, chills, muscle pain, achy all over, nausea, felling unwell, very dizzy and back pain on 26Jan2021 19:30. No treatment was received for the events. Outcome was unknown. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 56 | 2021-02-28 | abdominal pain upper |
legs cramps; stomachaches; has a history of heart palpitations/she felt her heart started rushing mo...
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legs cramps; stomachaches; has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat; sore arm; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the left arm, on 09Jan2021, at single dose, for COVID Prevention/COVID-19 immunization. Medical history included heart palpitations. Concomitant medication included unspecified medication for heart palpitations. The patient did not receive any other vaccines on the same day as BNT162B2. On 09Jan2021 (the same day as the patient received the vaccine), she developed sore arm which went on about for three days. The patient reported she put rubbing alcohol on it and that helped. On 12Jan2021 (day three after the vaccine), the patient experienced leg cramps and stomachache which went on about for 24 hours. The patient reported that she has a history of heart palpitations, but when she got the vaccine, on 12Jan2021 (day three after the vaccine), she felt her heart started rushing more, she had rapid heartbeat, but then she got it under control. She reported she has some pills for that, so she took an extra dose of her pills and that helped out with the palpitation. The patient recovered from the event sore arm on 12Jan2021; from leg cramps and stomachaches on 13Jan2021; and from "has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat" on an unspecified date.
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| 56 | 2021-03-01 | abdominal pain |
abdominal pain; mild muscle soreness at site; Fatigue; never feels rested or wants/needs to sleep; T...
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abdominal pain; mild muscle soreness at site; Fatigue; never feels rested or wants/needs to sleep; This is a spontaneous report from a contactable Consumer (patient). A 56-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 56-year-old) on 21Jan2021 as a single dose for COVID-19 immunisation, lot number: EL8982. Medical history included gall bladder, liver disease (diagnosed in 2008, 2017 exam fully functional), Umbilical (umb) hernia and ulcer. Patient had allergy-severe hives caused by plasma transfusion. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Other medications within two weeks prior to the vaccination was reported as not applicable (N/A). On 21Jan2021 patient received the first dose, following day (22Jan2021) mild muscle soreness at site, ongoing fatigue, never felt rested or wanted/needed to sleep, a lot. Noticed abdominal pain, did not connect the two. All events considered serious due to disability or permanent damage. No treatments received for the events. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was not tested for Covid post vaccination. Since the vaccination patient had not been tested for COVID-19. Patient had not recovered from the event fatigue and recovered with sequel (recovered with lasting effects) from the other mentioned events.
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| 56 | 2021-03-01 | nausea | nausea, terrible body pain, terrible headaches |
| 56 | 2021-03-02 | nausea |
Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontane...
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Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration at right arm on 11Feb2021 at 4:15 PM at single dose for COVID-19 immunization. Medical history included allergies to penicillin, glaucoma (reported as glaucomo) and high blood pressure. Concomitant medication included metroprolol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 20Jan2021 at single dose for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at a hospital. There was no other vaccine in four weeks. The patient was no COVID prior to vaccination and she was not tested for COVID post vaccination. The patient experienced bleeding upon injection, large bruise, extreme nausea, chills, fatigue, and headache, all on 12Feb2021 at 04:00 AM. She did not receive any treatment in response to the events. The outcome of the events was recovering.
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| 56 | 2021-03-02 | vomiting |
VOMITING for two days after shot and ondansetron prescribed, SWOLLEN GLANDS ON LEFT SIDE NECK AND CL...
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VOMITING for two days after shot and ondansetron prescribed, SWOLLEN GLANDS ON LEFT SIDE NECK AND CLAVICAL AREA, NUMBNESS IN HANDS AND FINGERS, RAISED BLOOD PRESSURE, 103F FEVER on DAY AFTER SHOT
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| 56 | 2021-03-03 | nausea |
Extreme Body aches, extreme headaches, extreme chills, fever 105.2, pain in the arm, dizziness, nau...
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Extreme Body aches, extreme headaches, extreme chills, fever 105.2, pain in the arm, dizziness, nausea, fainted at 6 pm on 02/27/21,, no response or movement. Blood pressure dipped down to 60/42 ...Ambulance came. EMT measured the blood pressure... 60/42 Was taking Tylenol 2 tablets of 500 mg. (max out) Fever will go down for an hour but would be back with extreme chills. Symptoms Fever, chills, body aches persisted for 30+ hours.
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| 56 | 2021-03-03 | nausea |
Lips felt like being shocked - then labored breathing. That resolved. Head felt like exploding with...
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Lips felt like being shocked - then labored breathing. That resolved. Head felt like exploding within minutes of shot. That lasted into 2nd day. Lots of dizziness, nausea & headache into day 2
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| 56 | 2021-03-03 | nausea, indigestion, decreased appetite |
Onset of symptoms was about 15 hrs following injection: Severe reflux and gastric distress (nausea);...
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Onset of symptoms was about 15 hrs following injection: Severe reflux and gastric distress (nausea); chills; fever to 100.8; muscle, bone and joint aches; severe fatigue; weakness; slight headache, no appetite. Alleviated somewhat with naproxyn sodium and benadryl. I also felt like I had cardiac arrhythmias. Slept most of day on 2/27. Felt improved morning of 2/28 and back to "normal" Monday 3/1.
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| 56 | 2021-03-04 | vomiting |
Started feeling dizzy, dizziness progressively worsened to the point were any movement was making me...
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Started feeling dizzy, dizziness progressively worsened to the point were any movement was making me throw up violently. This lasted 2 days, then my husband took me to the emergency room. I could not walk with out help due to the dizziness and being unbalanced. The gave me IV fluids, and medications for vertigo and nausea. The ER doctor recommended physical therapy for vertigo.
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| 56 | 2021-03-09 | vomiting |
Room spinning unable to stand up; when attempting to stand vomitting uncontrollably; lasted 2-days; ...
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Room spinning unable to stand up; when attempting to stand vomitting uncontrollably; lasted 2-days; unable to walk or stand; crawled to make it to the bathroom; - Started Saturday evening, February 6 - Monday, February 8 when I went to urgent care
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| 56 | 2021-03-20 | nausea |
feeling lethargic, tired, like wanting to take a nap very often; feeling lethargic, tired, like want...
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feeling lethargic, tired, like wanting to take a nap very often; feeling lethargic, tired, like wanting to take a nap very often; some nausea; This is a spontaneous report from a contactable other health professional (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261), via an unknown route of administration on Left arm on 03Feb2021 17:00 at single dose for covid-19 immunisation administered by healthcare worker. Medical history was none. Concomitant medications were not reported. The patient stated she received her first dose of Pfizer-BioNTech COVID-19 Vaccine yesterday at 5 o'clock (03Feb2021). She wanted to know if the following two are common side effects: "some nausea" and "feeling lethargic, tired, like wanting to take a nap very often". Has been experiencing nausea this morning before getting out of bed and just a little bit before noon was when she felt it. Had an appointment about 4:45pm and had shot about 5pm. Adverse events reported prior to vaccination was none. Vaccine was not administered at Military Facility. Previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The seriousness was reported as non-serious. The outcome of the event nausea was recovering and for the other events it was unknown. Information on the lot/batch number has been requested.
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| 56 | 2021-03-24 | vomiting, nausea, diarrhea, decreased appetite |
dehydrated; shaking; bowel movement that was loose but not like it was, not diarrhea; she had a litt...
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dehydrated; shaking; bowel movement that was loose but not like it was, not diarrhea; she had a little bit of something in her bladder, in her urine; she had a little bit of something in her bladder, in her urine; woke up completely drenched; Blood pressure dropped; Vomiting; nauseated and couldn't eat; nauseated and couldn't eat; high fever/ It got to over 103; Diarrhea is like a greenish color; diarrhea; Chills; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 56-years-old, administered in Arm Right on 03Mar2021 15:00 (Lot Number: EN6204; Expiration Date: 30Jun2021) as single dose for COVID-19 immunization. Medical history included kidney and pancreas transplant patient since 01Apr2014 (On 01Apr2021, will be seven years since her transplant), Gastroparesis from 2005, Small intestinal bacterial overgrowth from 2019 (hasn't had any issues with that in over a year), Diabetic macular edema (Doesn't think Diabetic macular edema pertains to anything with the COVID Vaccine), pacemaker in her stomach (Procedure for pacemaker for stomach performed first time in 2006. Stomach pacemakers only last eight to ten years. Had the battery replaced in 2017), she had previously had C-Diff, high blood pressure (Doesn't have high blood pressure anymore), immunosuppressed. The patient's concomitant medications were not reported. Patient states about a week ago, she talked to someone at clinic, reporting after she got the first dose of the Pfizer COVID 19 vaccine. She had reported she had diarrhea. Clarifies she got her vaccine on 03Mar2021 at 15:00PM in the right arm. She previously reported she started having diarrhea in the night, Thursday (04Mar2021), and had it for ten days. At that time, when she had reported, she only had diarrhea. Diarrhea is like a greenish color. Has been trying not to eat heavy things, but diarrhea is still a greenish color. She contacted her stomach doctor and he wanted her to do a COVID 19 test, which was negative; and a whole stool work up because she had previously had C-Diff. She did all that and turned it in Friday. Adds she did have the chills a little on the day of the vaccine but they went away. Reporting new events today including on 13Mar2021 she started having a fever. It got to over 103; she was so nauseated she couldn't eat (13Mar2021); with chills (03Mar2021) and shaking (unspecified date). She treated the fever with Tylenol and got some relief but then her fever would go back up. She thinks she was getting dehydrated (Mar2021) from all the diarrhea and then she started to throw up on Tuesday (16Mar2021). That day she was admitted to the hospital, 16Mar2021. At the hospital they did another COVID 19 test that was negative; blood tests; urine test; US kidney; CAT Scan whole stomach; and they could not find anything that could cause her symptoms. Adds they did say she had a little bit of something in her bladder, in her urine (unspecified date). While hospitalized she was treated with IV antibiotics; Phenergan and Zofran which controlled the nausea and vomiting. Her fever went down to 99 by Friday. Adds she did have one episode on Friday of low blood pressure (19Mar2021) and they were watching it. She was discharged on Saturday and has not had a fever since she came home. Adds she did have a bowel movement that was loose but not like it was, not diarrhea (unspecified date). Mentions for the last two nights she woke up completely drenched (20Mar2021) but she did not have a fever. Adds she felt a little chill last night, but she just covered up with her blanket. She feels her dehydration is improving. Therapeutic measures were taken as a result of dehydrated, high fever/ it got to over 103 (pyrexia), vomiting, nauseated and couldn't eat. The outcome of dehydrated was recovering, diarrhea and diarrhea is like a greenish color was recovered on 18Mar2021, high fever/ it got to over 103 was recovered on 19Mar2021, chills was not recovered, vomiting recovered on 17Mar2021, nauseated and couldn't eat recovered on 18Mar2021, blood pressure dropped recovered on 19Mar2021, woke up completely drenched was not recovered, and all other events was unknown. The patient was hospitalized for dehydrated from 16Mar2021 to 20Mar2021.
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| 56 | 2021-04-03 | abdominal discomfort |
Very sore arm for several days after shot. On day 9 I started to get a low grade fever, body aches,...
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Very sore arm for several days after shot. On day 9 I started to get a low grade fever, body aches, headache, upset stomach and extreme fatigue. Day 10 I was having severe memory issues. I struggled with putting words together and forgetting things like passwords and even how to turn off my computer. My husband was very alarmed and thought I was having a stroke. He took me to the ER.
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| 56 | 2021-04-12 | indigestion, difficulty swallowing |
allergic reaction/Allergic anaphylactic reaction; lungs were filling up with fluid; throat was closi...
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allergic reaction/Allergic anaphylactic reaction; lungs were filling up with fluid; throat was closing; Main trouble is breathing and is out of breath; legs sore; Throat sore; Cough; hard for her to walk; tired; trying to swallow a tablet and digest it and it gets stuck; trying to swallow a tablet and digest it and it gets stuck; breathing was heavy; choking; trying to swallow a tablet and digest it and it gets stuck; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 24Mar2021 (Lot Number: ER2613) as a single dose for to prevent COVID (covid-19 immunisation). Medical history included having blood clot from 2019 to Mar2021 which the patient stated a couple of weeks ago (Mar2021), she had an ultrascan in her leg and the blood clot was not there, but she is on medication. The patient has recovered completely from blood clot (not ongoing). Concomitant medication included warfarin (WARFARIN) to prevent from having blood clot ongoing since Jun2019. The patient previously took gabapentin for pain but had throat started closing, allergic reaction, coughing and was intubated until she was released from hospital; and albuterol [salbutamol] for dyspnoea but had nebulizer to open up her airways and prevent closing and did not work (drug ineffective). The reporter mentioned that the patient ended up in the ICU because of the COVID vaccine. As soon as the vaccine was administered within seconds, the patient experienced a reaction and was given an epi pen, another epi pen even an epinephrine drip and was sedated and intubated. The reporter mentioned that they gave the patient the first shot of epi pen and it did not work, and she was given a second one and a third one plus steroids. By the time the ambulance people arrived, they hooked the patient up to an IV and gave her additional epinephrine and administered another epinephrine. The ambulance guy told her; she does not need to keep up with them because they needed to go to the hospital ASAP because the patient is not getting better but getting worse. Once the patient got to hospital, she was intubated because her throat was closing. The reporter stated that the patient has allergies to begin with and this was worse than the first time she had to be intubated. The epi pens did not work, the patient was intubated and then had to be sedated. The patient was on Propofol in order to sedate her and later on in the evening was given Fentanyl to relax her then the epinephrine drip was removed at 6 pm on 24Mar2021. The epinephrine drip was started in the emergency room and the patient could not be moved to the intensive care unit until she was somewhat stable. The patient was moved to the intensive care unit and was there overnight and by the time next morning she was able to be extubated where they removed the tube from her around 9:30 to 10:00 25Mar2021. Of course, the patient was taken off Propofol, but she went through a lot and her legs are sore, throat is sore, and is coughing on 25Mar2021 because of the side effects from being intubated and that she went through a lot. The intensive care unit doctor said that the patient can no longer have the vaccine and she would only be 70% protected till whenever they are not sure how long the vaccine will last. The adverse events almost took the patient's life which made the reporter angry at that. The reporter is not sure what the contents in the vaccine that it in the other drugs and vaccines since there is something that is contained in all of them and the patient was not allowed to have any whether it is the Pfizer or Moderna and it is even up for discussion for even the flu shot because of the reaction and there does not want to be any chances and that everything should be proceeded with caution. The reporter wanted to know what is in the COVID 19 vaccine to see about what could have caused the allergic anaphylactic reaction. The reporter stated and the fact that the epi pen did not work, she was taken aback. The reporter added that the doctor had a hard time intubating because of her throat but they were able to intubate from the second time. The reporter stated that it is taking a while but her wife is recovering and feeling it is taking a while taking a little bit longer. The reporter also stated that they kept the patient in the intensive care unit overnight and after the tube was removed in the morning, by the late afternoon she was moved to a different floor to continue to be observed and the intensive care doctor said 2 days out her wife would be safe to go. The patient stood up but it was hard for her to walk on 25Mar2021 because it could have been from the epi pen, but she is not sure. The patient stated the side effect came out of the allergic reaction and it was on Thursday 25Mar2021. Patient stated the main trouble is her breathing, she is out of breath still and really sore throat on 25Mar2021. The patient stated that the leg sore is still ongoing and is about the same. It was mentioned that the throat sore was still ongoing but some days are worse and some days are better. The patient stated that when she has a problem trying to swallow a tablet and digest it and it gets stuck on Mar2021. It was stated that the cough was not going away. The cough comes and goes away. She will cough for five minutes constantly and then it disappears then she will fall asleep and wake up coughing. It's as if she is choking (Mar2021). When she is talking, she coughs more. With regards to the allergic anaphylactic reaction, the patient stated she is experiencing the aftereffects of the allergic reaction and being intubated like being out of breath. The patient stated that will come in time and that's what happens when she gets intubated. Her breathing was heavy and comes back fully with rest on Mar2021. This has taken a lot out of her. She was feeling tired which was still ongoing it is about the same but comes and goes on 25Mar2021. The patient is experiencing lingering side effects and the patient does not feel as if she has recovered completely. It was also mentioned that the patient was intubated on 24Mar2021 to 25Mar2021. It was reported that treatment of the patient included Epi Pen, Epinephrine Autoinjector USP 0.3 mg (Epinephrine injection manufacturer was Mylan) which the patient was given at least three injections (two in the right leg and 1 on the left) then received another in the ambulance (unknown site). Patient received an Epinephrine drip and it was like 0.1 mg all the way up until 6 pm (only on 24Mar2021). The epinephrine drip was started when patient was intubated at the hospital. It was given for patient's allergic reaction through IV. The patient's lungs were filling up with fluid so her airway was restricting her from breathing and to prevent damage of the lungs that is when the intubation came in. The patient also received Prednisone which the reporter does not recall when this medication was started it may have been after the epinephrine drip was removed but she is not sure if they started the prednisone after or if it was the same evening which the reporter kind of thinks it was. The reporter stated that the patient took Propofol 24Mar2021 to 25Mar2021 which was given through the patient's IV and was given to help her airways being intubated, they sedate their patients. The patient also received fentanyl which must have been added either right before Epinephrine drip was removed or after but reporter does not recall. Patient was given Fentanyl 24Mar2021 to 25Mar2021 through her IV. Patient received this medication to relax because sometimes it is like some patients tend to want to sit up and kind of hear you, hear what people are saying and to relax patient sometimes because they can get scared and not exactly sure what is going on. The events anaphylactic reaction, pulmonary oedema, throat constriction and breathing difficult. The patient underwent lab tests and procedures which included lung was checked from a CT scan was unknown results on 12Jun2019, D dimer test was elevated on an unspecified date, ultrascan in her leg (ultrasound scan) blood clot was not there on Mar2021 and weight was probably weighs 180 or her weight may be a little less like 175 on an unspecified date. The outcome of the events anaphylactic reaction and throat constriction were recovering, as for the events leg pain, throat sore, cough and tiredness were not recovered while the outcome of the other events was unknown.
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| 56 | 2021-04-12 | nausea, abdominal pain upper |
elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; s...
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elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; smell altered on and off; taste altered on and off; muscle pain; headache; all over pain first 36 hours preventing sleep; a little bleeding from bowel at 24 hrs and nose at 36 hrs; Burning like fire at injection site; Hair follicle pain; a little bleeding from bowel at 24 hrs and nose at 36 hrs; extreme armpit pain like torn muscles; no use of arm first two days; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ER 8733) via an unspecified route of administration at left arm on 27Mar2021 15:15 at a single dose for Covid-19 immunization. Medical history of patient was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included multivitamin, calcium and fish oil (other medications the patient received within 2 weeks of vaccination). Patient stated as injected arm went numb within 15 minutes and stayed that way 48 hrs, extreme armpit pain like torn muscles began at 48hrs, bad stomach cramps first 24 hours, a little bleeding from bowel at 24 hrs and nose at 36 hrs, no use of arm first two days could not even put a robe on, fever that climbed to 101.7 until breaking first 48 hrs, smell and taste altered on and off. Burning like fire at injection site 12 hours later that came and went in waves for another 36 hrs. Hair follicle paint at 12 hrs when headache started, headache lasting 72 hours, all over pain first 36 hours preventing sleep, nausea began within first hour lasting about 40 hours, muscle pain first 48 hrs, fatigue begins at 36 hrs and continues, elevated resting heart rate since first night, dizziness and light headedness from 1st hour. The patient underwent lab tests and procedures which included body temperature was 101.7 and heart rate was elevated (elevated resting heart rate since first night) on 27Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The outcome of event was recovering.
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| 56 | 2021-04-13 | abdominal pain, diarrhea |
Received 2nd dose of vaccine on Wednesday. About 5 hours after 2nd dose, chills and fever. Part-way ...
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Received 2nd dose of vaccine on Wednesday. About 5 hours after 2nd dose, chills and fever. Part-way through night (about 12 hours after) started with violent diarrhea and intense abdominal pain. Fever continued for about 65 hours. 2 X 3 inch rash appeared on thigh on Friday, 2 days after receiving vaccine. Liquid diarrhea continued despite fever breaking, as did intense abdominal and back pain. Pain medication helped temporarily with pain. Immodium tried on Saturday but only made things worse. Became dehydrated. Visited emergency department on Sunday morning, 4 days after receiving vaccine. Was diagnosed with infectious colitis and possibly Lyme disease. Treated with doxycycline and metronidazole. Received 2 liters of IV fluid for dehydration.
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| 56 | 2021-04-19 | vomiting, nausea |
Woke up at 2am (approx 14 hrs after vaccine) with bad chills/shaking/sweating, fell asleep for a few...
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Woke up at 2am (approx 14 hrs after vaccine) with bad chills/shaking/sweating, fell asleep for a few hours then woke up feverish, bad headache, major bodyaches, nauseous with throwing up throughout the day, fatigue, weakness and sore arm at injection site so I slept most of the day in general, in between sickness. 2nd day after vaccine, April 15th I woke up with still a bad headache, bodyaches, nauseous, and sore arm. Headache subsided that night. April 16th I still was nauseous most of day and sore arm. Took extra strength tylenol a couple times on April 13th, 14th and 15th.
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| 56 | 2021-04-20 | abdominal pain, diarrhea |
Fever; chills; severe abdominal and back pain; severe abdominal and back pain; severe cramping; unre...
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Fever; chills; severe abdominal and back pain; severe abdominal and back pain; severe cramping; unremitting liquid diarrhea; infectious colitis; rash on leg; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 56-years-old via an unspecified route of administration, administered in Arm Left on 31Mar2021 08:45 AM (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included Coronary artery disease; Acid reflux; possibly Lyme disease (1-4 days prior to vaccine), known allergies was Paradoxical reaction to Benzodiazepines. Concomitant medications included clopidogrel; ezetimibe; evolocumab (REPATHA); rosuvastatin and Ome. No other vaccine in four weeks. The patient received first dose of BNT162b2, at the age of 56-years-old via an unspecified route of administration, administered in Right arm on 10Mar2021 12:00 PM (Lot Number: EN6207) as single dose for covid-19 immunisation. Patient experienced Fever, chills, severe abdominal and back pain, severe cramping and unremitting liquid diarrhea, infectious colitis, rash on leg all on 31Mar2021 with outcome as Recovering. The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment received was IV fluid, antibiotics. No covid-19 prior vaccination. Covid-19 test post vaccination was PCR, covid test type post vaccination was Nasal Swab on 04Apr2021, result was Negative.
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| 56 | 2021-04-22 | abdominal pain |
I have suffered abdominal cramps that began 2 days after injection - this lasted through April 22, 2...
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I have suffered abdominal cramps that began 2 days after injection - this lasted through April 22, 2021. I suffered allergic reaction within an hour of receiving the vaccine and I read that the abdominal cramps are also a sign of an allergic response to the vaccine.
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| 56 | 2021-04-28 | diarrhea, vomiting, abdominal pain upper, abdominal distension |
it was not liquid coming out of my rectum but a grey/taupe very soft stool; gassy; my stomach and ba...
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it was not liquid coming out of my rectum but a grey/taupe very soft stool; gassy; my stomach and back side were very pain full; sour belches; vomited; having dark liquid diarrhea pouring out of my rectum; I could not sleep; my entire stomach area was swollen and in extreme pain just to touch; my entire stomach area was swollen and in extreme pain just to touch; my back side was raw and bleeding; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 08Apr2021 18:45 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included blood pressure (BP), sleeping, cholesterol. Patient had no covid prior vaccination. Concomitant medications included calcium and unspecified Multi Vitamin. No other vaccine in four weeks. The patient previously took erythromycin (EMYCIN) and experienced allergies, hydrocodone bitartrate/paracetamol (VICODIN) and experienced allergies. The patient experienced her back side was raw and bleeding on 12Apr2021, sour belches on 12Apr2021 08:00, vomited on 12Apr2021 08:00, having dark liquid diarrhea pouring out of her rectum on 12Apr2021 08:00, could not sleep on 12Apr2021, her entire stomach area was swollen and in extreme pain just to touch on 12Apr2021, her stomach and back side were very pain full on 13Apr2021, it was not liquid coming out of her rectum but a grey/taupe very soft stool on 14Apr2021, gassy on 14Apr2021. No treatment received. No covid tested post vaccination. Clinical course: She received the first Pfizer vaccine on 08Apr2021 evening, she thought it was easy, no problems. 12Apr2021 morning driving to work she started having sour belches, she got to work and ran to the bathroom, she vomited #6 times while having dark liquid diarrhea pouring out of her rectum, it finally stopped, 3 hours later it started again, she vomited 4 more times with more dark liquid pouring out of her rectum. Her boss sent me home. At home she was running back and forth to the bathroom the rest of the day with dark liquid diarrhea and another vomiting session throwing up #5 more times for a total of #15 Times. She could not sleep as her entire stomach area was swollen and in extreme pain just to touch and her back side was raw and bleeding. 13Apr2021 morning she vomited 3 times along with still having dark liquid diarrhea pouring out of her rectum and her stomach and back side were very pain full. 14Apr2021 she could not go to work again, she had no vomiting but continued with the on going dark liquid until 3:00 PM, she went to the bathroom and it was not liquid coming out of her rectum but a grey/taupe very soft stool. Her stomach area continued to hurt, she was still gassy. She only ate a banana, toast and Gatorade per the Dr. This was such a horrible experience. After the first shot she was praising the Pfizer Shot, now she would not. She did no really want the second shot after this experience. She was a new widow struggling, she had no one to help her, she had no phone as she had thrown up on her new phone and ruined it. This was such a terrible experience. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 57 | 2021-01-01 | nausea | Fever 101.2, body aches, joint pain, nausea |
| 57 | 2021-01-01 | vomiting |
On the evening of Sunday December 27th I became violently ill. I began vomiting and continued all n...
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On the evening of Sunday December 27th I became violently ill. I began vomiting and continued all night long. I had severe body aches and chills. I was unable to find my thermometer so am not sure of tempertature. I had lower back pain so severe I couldn't lie down. I tried to take Tylenol but was unable to keep it down. By morning I got access to Tylenol suppositories, Dramamine, and a thermometer. My temperature before Tylenol was 104.4. These symptoms continued over the next 3 days though vastly improved with Tylenol, Dramamine and IV fluids. I received a negative COVID test on Thursday. I have only been this ill once before in my life. By Thursday I was not longer febrile, only weak and exhausted. I have to now determine whether or not to get the second vaccination. I know this seems to be a somewhat delayed reaction. Any advice would be appreciated.
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| 57 | 2021-01-03 | nausea |
10 minutes after injection, patient reported numbness of bottom of the feet, hands, and is experienc...
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10 minutes after injection, patient reported numbness of bottom of the feet, hands, and is experiencing hot/cold episodes, shaking, and pallor of lips. She also reported intermittent nausea. No changes in mental status. Patient was transferred to the ER. In the ER, she denied shortness of breath, facial swelling, hives, vomiting or diarrhea. No chest pain or voice changes. Her EKG was unremarkable. Her symptoms resolved with time, and was discharged on prednisone 20 mg PO for 4 days
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| 57 | 2021-01-03 | nausea, diarrhea |
Itchiness in scalp, face and both arms that feels like bugs crawling on my skin, since 1/3. Nausea...
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Itchiness in scalp, face and both arms that feels like bugs crawling on my skin, since 1/3. Nausea and diarrhea on 1/4 in the morning, and still have the itching.
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| 57 | 2021-01-04 | vomiting |
48hr Headache which evolved into a migraine with vomiting,lethargy and pain at injection site 1...
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48hr Headache which evolved into a migraine with vomiting,lethargy and pain at injection site 12 hour after the injection, fever 99.1
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| 57 | 2021-01-04 | nausea, diarrhea |
First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I ...
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First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I also experienced headache, nausea, diarrhea and fever. I continue to have tingling in my face. I called employee health, and they told me to isolate. Because they were trying to rule out if it was COVID, but test was negative.
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| 57 | 2021-01-04 | nausea |
Headache; Really really tired; Really really cold; Chills; Nausea; This is a spontaneous report from...
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Headache; Really really tired; Really really cold; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient herself). This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685, Expiration Date Mar2021), via intramuscular, on 28Dec2020 at 13:30 at single dose for COVID-19 immunisation. Vaccine location was left arm. Age at vaccination was 57-year-old. Relevant medical history included anxiety and fibromyalgia. The patient was receiving concomitantly a drug (unspecified) at dose of 60 mg daily from Sep2020. This patient stated that she is not a healthcare professional but works in the diet area/kitchen of which is a hospital. On 29Dec2020 she felt really really tired, got really really cold, had chills, nausea. On 30Dec2020, in the morning, she had onset of headache. She still had a slight headache and a little nausea, but did not have the chills. She did not knowif this has anything to do with the vaccine but wanted to report the information. She did not plan to change her dose; she was scheduled to get the second dose on 15Jan2021 at 1:00pm which she still plans to get. The outcome of 'really really fatigue' and 'really really cold' was unknown; the event 'chills' recovered in Dec2020; the outcome of 'nausea' and 'headache' was recovering.
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| 57 | 2021-01-04 | nausea, vomiting, diarrhea |
Patient received her Vaccine on 12/16/2020. Afterwards she developed symptoms of fever, chills, diar...
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Patient received her Vaccine on 12/16/2020. Afterwards she developed symptoms of fever, chills, diarrhea, nausea, vomiting and headache that became worse over time and on day os presentation to our hospital on 1/2/2021 she was having photophobia. Current headache at time of admission had been persistent for over a week. Patient has no immunocompromising risk factors and was diagnosed with confirmed CMV meningitis. She was also admitted with transaminitis.
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| 57 | 2021-01-04 | nausea, vomiting |
Shortly after vaccination developed dizziness and nausea. Within 30 minutes had low blood pressure a...
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Shortly after vaccination developed dizziness and nausea. Within 30 minutes had low blood pressure and pulse. Taken to ER. Also developed vomiting. Treated with epinephrine. Initially improved, then after 40 minutes heart rate dropped to low 40's and developed chest pain. Treated with 4 mg solumedrol, benadryl and more IV fluids. Slow recovery and observed over 5 hours. Went home.
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| 57 | 2021-01-04 | nausea |
Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swel...
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Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swell and break out in hives. Approx. 45 minutes later she became flushed, felt lightheaded/intoxicated/giddy/silly while driving home. She said she was extremely hungry ("like a big dose of steroids"). She states her ears were ringing and when she laid down at 2130 she could feel her heart beating throughout her body. This AM she reports feeling "hungover/groggy/nauseated". She denied any lip/tongue swelling, any lip or extremity tingling, difficulty breathing, any injection site redness/heat/swollen/painful area, fever, chills, or ever having a vaccine reaction previously. Spoke with individual w/pharmacy. Advised to report to VAERS. Not an expected reaction. Possibly related to aleve vs. covid vaccine.
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| 57 | 2021-01-05 | nausea |
10 minutes after receiving vaccine, developed flushing and tingling of tongue. 45 minutes later, dev...
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10 minutes after receiving vaccine, developed flushing and tingling of tongue. 45 minutes later, developed nausea. 1 hour and 45 minutes after vaccine, developed laryngitis. Sent to ED for evaluation and treatment. Received Solumedrol and Pepsid in ED with improvement. Discharged home by or before 8pm with resolution of laryngitis and other symptoms. Reports "feeling great" this a.m.
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| 57 | 2021-01-05 | nausea |
Feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at les...
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Feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect); Intermittent dizziness after an hour; H/A after an hour; that diminished over the next 12 hours but slightly lingered; Metallic taste in the mouth after an hour; Nausea after 8 hours (diminished by the next morning); This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular on the left arm on 29Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included Hashimoto. Concomitant medication included omeprazole, rosuvastatin calcium (CRESTOR), levothyroxine, magnesium and ascorbic acid, retinol, tocopherol (OCUVITE). The patient previously took zinc and experienced allergies. On 29Dec2020, the patient experienced intermittent dizziness after an hour, metallic taste in the mouth after an hour, H/A (headache) after an hour (that diminished over the next 12 hours but slightly lingered) and feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect), and nausea after 8 hours (diminished by the next morning). No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Outcome of the events was recovered with sequel.
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| 57 | 2021-01-05 | vomiting, decreased appetite |
Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a h...
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Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a headache about one hour after. Took 1000 mg of Tylenol; and I was feeling okay. Just arm was sore. Not extremely sore. 8 pm at night - started shaking; knees were knocking together; severe chills; and it took a few minutes to recognize what was happening - took temp. 99.4; took another 1000mg tylenol; went to bathroom and without notice - puked; woke up an hour after going to bed with worsened chills; 10:30 pm - temp 102.4; too early to take more Tylenol and so took pharmacy's version of Nyquil. Slept through the night after Nyquil but woke up with chills continuing - temp 103. 8 at 4:30 am; and then sat at side of bed and took tylenol 1000 mg and got up to go to bathroom and couldn't walk forward and felt my arm hurt really really bad; couldn't walk forward; I leaned against the wall and bounced against the next wall and kept walking and grabbed a bedroom doorknob and got into the bathroom and fell on toilet and then crawled to couch because I couldn't walk straight. Stayed on a couch for two hours and then it was gone. Fever and chills continued that whole day on 24th. Didn't eat/had no appetite. Christmas day -no fever. Felt shaky though - like I'd been super sick. No appetite still. Felt woozy and shaky inside (felt shaky inside) and that lasted for several days. Appetite still remains poor. 02 stats were low through all of it - four liters (up two liters than normal. Contacted: a pulmonologist - Dr. and she helped with O2 questions.
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| 57 | 2021-01-05 | nausea, vomiting, diarrhea | nausea, diarrhea, vomit x 1, low grade fever 10 days after vaccine given |
| 57 | 2021-01-06 | abdominal discomfort |
I felt achy 24 hours after the exam but after 72 hours started feeling worse and developed a fever w...
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I felt achy 24 hours after the exam but after 72 hours started feeling worse and developed a fever which progressed to a head cold and further progression to full Upper Respiratory infection, viral in nature. 168 hours later, lost sense of taste and smell and had some GI discomfort.
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| 57 | 2021-01-06 | nausea |
ON 12/31/2020 I HAVE A HAD SLIGHT FEVER, HEADACHE , NAUSEA, BODY ACHES, CHILLS, HAND TREMORS, DIZZ...
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ON 12/31/2020 I HAVE A HAD SLIGHT FEVER, HEADACHE , NAUSEA, BODY ACHES, CHILLS, HAND TREMORS, DIZZY AND LIGHTHEADED THAT LASTED FOR 3 DAYS. SINCE THEN I HAVE A BAD HEADACHE, FEELING NAUSEA AND VERY LIGHT HEADED AT TIMES.
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| 57 | 2021-01-06 | nausea |
On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early a...
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On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early am got up at 5 am. Took Tylenol 1000mg. Went to work. Around 9am of 1/6/21 chills more pronounced body aches. Temp 99.3. Continued to feel poorly, rechecked temp 1.00 pm. Now 99.9. Sent home. At 2:15 pm temp 104.00. More severe chills and body pain, nauseous. Toast for dinner, Tylenol again at 6 pm , recheck temp 100.8. Went to bed. 1/7/22 am some body aches, not as severe, nauseous and migrai. Type headache. Did no take temp, because didn't feel one. Call to nurse at covid vaccine holiness. Check temp while on phone 97.4.
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| 57 | 2021-01-06 | vomiting |
Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in...
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Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in her neck; sick; She doesn't know if she had the flu bug or not; She also had very high blood pressure. It was through the roof/Blood pressure was high and she was concerned she would have a stroke; Muscle soreness; Arm soreness; This is a spontaneous report from a contactable healthcare professional (physical therapist). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 21Dec2020 08:15 at a single dose for COVID-19 immunisation; and sumatriptan from 25Dec2020 to an unspecified date at unknown dose and frequency (standard unknown dose/ She only gets 9 pills a month) for migraine. Medical history included ongoing migraine, obesity (She would say she was kind of obese), coeliac disease (She had Celiac disease and cannot eat gluten which was diagnosed since she was 4), chronic back pain (this was diagnosed a couple of years before she took the COVID vaccine), spinal stenosis (this was diagnosed a couple of years before she took the COVID vaccine), and pain (she took hydrocodone for pain but did not take any that day). Concomitant medication included hydrocodone for pain. Prior Vaccinations (within 4 weeks) and events following prior vaccinations were none. The patient had the vaccine on 21Dec2020, and she got sick on Christmas day. She was vomiting at 14:00 and did not know if it was a side effect or not. She did have arm soreness muscle soreness at 15:00, that evening and the next day too. She normally gets a migraine once a month. She does not normally throw up with a headache though. The vomiting started when she threw up twice on 25Dec2020, then once on morning of 26Dec2020. She also had very high blood pressure. It was through the roof. She did not know if that was related to drug for migraine or vaccine. She also had the headache at 14:00 the whole time. She believed she threw up before she took Sumatriptan. The muscles got rigid and tight in her neck and she doesn't think she took it. She threw up and then she took it. She did not have a lot or expiration. There was no ER nor physician's office required. She would have it if her car was not buried in snow. Her blood pressure was high and she was concerned she would have a stroke. It was usually around 110/70 and was always very low usually. She did not know if it was accurate, but it was 165/124 at one point and she did know her pulse was accurate. She did not provide her pulse rate. She did not know if she was throwing up because her blood pressure was high and did not know if blood pressure was high because of Sumatriptan. She only gets 9 pills a month. She did not know if high blood pressure was one of the side effects. It was not a real safe medication to take once a day. She only took it once a month and only once that day. She had never thrown up with migraines before and was just concerned. She doesn't usually take her blood pressure and doesn't know if the Sumatriptan always makes it go up or not. She doesn't know if she had the flu bug or not. The action taken in response to the events for bnt162b2 was not applicable, while for sumatriptan was unknown. Clinical outcome of sickness and influenza was unknown, for headache was recovered on 27Dec2020, while for the other events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the elevated BP and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-06 | nausea |
WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WI...
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WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WIT SCRATCHY THROAT AND RED NCK AND CHIN. THEATED WITH BENADRYL AND DECADRON FROM THE ED.
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| 57 | 2021-01-07 | vomiting, nausea |
Dizziness, Headache, Myalgia, Fever, NauseaVomiting, Intermittent jaw pain and rib pain Narrative: R...
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Dizziness, Headache, Myalgia, Fever, NauseaVomiting, Intermittent jaw pain and rib pain Narrative: Recommended that she seek emergent care
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| 57 | 2021-01-07 | nausea, vomiting | Dizziness, Headache, NauseaVomiting, arm sore at injection site,fatigue Narrative: |
| 57 | 2021-01-07 | nausea |
Headache; Dizzy; Fever; Nausea; This is a spontaneous report from a contactable Other HCP (patient h...
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Headache; Dizzy; Fever; Nausea; This is a spontaneous report from a contactable Other HCP (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unknown route, on 30Dec2020 at 08:45 at single dose for COVID-19 immunisation. Vaccine location was arm right. The patient was not pregnant. Relevant medical history included hypothyroidism, osteoporosis and COVID-19 (prior to vaccination). No known allergies. Relevant concomitant medications included levothyroxine and alendronate sodium (FOSAMAX). The patient was vaccinated at Workplace Clinic, age at vaccination was 57-year-old. No other vaccine was received in four weeks. Since the vaccination, the patient has not been tested for COVID-19. The patient developed nausea 20 minutes after vaccine (on 30Dec2020, at 09:05), then headache, dizzy, fever started about 2 hours after (on 30Dec2020, at 10:45). The patient was not treated for the events. The outcome from the events was unknown.
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| 57 | 2021-01-07 | vomiting, diarrhea, nausea |
Soreness, redness, itching to injection site Severe headache Nausea, vomiting and diarrhea Sym...
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Soreness, redness, itching to injection site Severe headache Nausea, vomiting and diarrhea Symptom last about 24 hours.
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| 57 | 2021-01-07 | diarrhea | arm more sore than first shot; diarrhea- mild |
| 57 | 2021-01-07 | vomiting |
burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swe...
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burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swelling in left arm; tingling swelling in left arm; pain left groin left leg with muscle weakness; pain left groin left leg with muscle weakness; vomiting; tiredness; weak; This is a spontaneous report from a contactable Nurse. This 57-year-old female Nurse (patient) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 29Dec2020 08:00 (at the age of 57-years) as single dose, Intramuscular in left arm for COVID-19 immunization. Medical history included allergies to penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. Concomitant drugs included ASA (ASA), Famotidine (FAMOTIDINE), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc (ZINC), magnesium (MAGNESIUM). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not test for COVID-19 after vaccination. On 29Dec2020 15:00 the patient experienced 'Burning Upper Nose/Throat', 'Heart Racing', 'Headache', 'Numbness', 'Tingling Swelling in Left Arm', 'Pain Left Groin Left Leg with Muscle' 'Weakness', 'Vomiting', 'Weak', and 'Tiredness'. The patient did not received treatment as a result of the event. The outcome of event 'Burning Upper Nose/Throat' was recovered on unspecified date, 'Heart Racing' was recovered on an unspecified date, 'Headache' was recovered on unspecified date, 'Numbness' was recovered on unspecified date, 'Tingling Swelling in Left Arm' was recovered on unspecified date, 'Pain Left Groin Left Leg with Muscle' was recovered on unspecified date, 'Weakness' was recovered on unspecified date, 'Vomiting' was recovered on unspecified date, 'Weak' was recovered on unspecified date, and 'Tiredness' was recovered on unspecified date. Information on the lot/batch number has been requested.
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| 57 | 2021-01-07 | nausea, abdominal pain |
had intermittent abdominal pain that hit at 72 hours (late last night, early this morning); began wi...
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had intermittent abdominal pain that hit at 72 hours (late last night, early this morning); began with nausea and it comes in waves/continues in waves along with the nausea, it comes and goes from moderate severe to low grade; headache; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID 19 vaccine on Wednesday close to noon and reported that, "I didn't notice any symptoms until yesterday morning (02Jan2021), I began with nausea and it comes in waves. I did have headache that began Friday evening (01Jan2021) and continues in waves along with the nausea, it comes and goes from moderate severe to low grade. I then had intermittent abdominal pain that hit at 72 hours (late last night, early this morning, 03Jan2021). No diarrhea associated with it. I can't find abdominal pain on the paperwork that was provided to me. is this also one of the expected or reported side effects?" The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 57 | 2021-01-09 | nausea |
Painful arm 12/27/2020 Headache 12/28/2020 Low grade fever,severe headache, chills,nausea 01/06/202...
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Painful arm 12/27/2020 Headache 12/28/2020 Low grade fever,severe headache, chills,nausea 01/06/2021
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| 57 | 2021-01-09 | nausea, vomiting, diarrhea | Rigors, fever nausea, vomiting. diarrhea Severe muscle spasming/contraction, headache |
| 57 | 2021-01-10 | nausea |
injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, l...
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injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, lymphadenopathy, blurry vision, dizziness; Tylenol 1 tab X 3 times per day during 3 days
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| 57 | 2021-01-10 | nausea |
nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day ...
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nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day the vaccine was given. injection site pain swelling, severe headache, developed chills at night joint pains, rashes on my face, feeling weak as if I dont have energy. At night time i went to the restroom 5 times with an interval of 5-10 minutes and i cannot even control my bladder it comes out continuously. Slow to comphrend or response. I stayed fully awake the whole night on the night when the vaccine was given to me and was able to sleep only the following day (sat) at 5 pm.
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| 57 | 2021-01-11 | diarrhea |
Pain at injection site (two days) Joint pain, predominantly in shoulders and knees (three days) Head...
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Pain at injection site (two days) Joint pain, predominantly in shoulders and knees (three days) Headache (three days) Diarrhea (three days) Extreme fatigue (three days)
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| 57 | 2021-01-11 | nausea |
Patient received vaccine around 10 am. She waited 30 minutes in the clinic with staff due to history...
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Patient received vaccine around 10 am. She waited 30 minutes in the clinic with staff due to history of numerous allergies (zantac, demerol, amoxicillin, paxil, gluten). After patient left the site, she returned around 11:18am reporting she was feeling poorly (specifically with nausea, headache, and itchy/sore throat). No lip swelling , shortness of breath, hives noted. Vital signs were monitored and were stable. Diphenhydramine 50mg given orally and EMS notified as per our company protocol. Patient left via ambulance at 11:32 in stable condition to Hospital .
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| 57 | 2021-01-11 | nausea | nausea, headache, fatigue, low grade temp |
| 57 | 2021-01-12 | abdominal discomfort |
1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red ...
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1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red swollen arms, dizziness, blurred vision, gastrointestinal symptoms, blood sugar 143, blood pressure 86/40, pulse 87, oxygen 88. We gave diphenhydramine 50mg at 2:16 pm. Then at 2:35 pm her symptoms were not improved her blood pressure was 80/40 so we gave one dose of 0.3mg epinephrine by auto-injector and called an ambulance. Post epinephrine her vision improved but her skin was still red and starting to itch. She was talking and said she was feeling a little better. She was taken by ambulance to the hospital for additional treatment. There was not reaction visible at the injection site it appeared to be all systemic.
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| 57 | 2021-01-12 | abdominal discomfort | Chills, fever, headache, body aches, upset stomach, pain in arm of vaccine |
| 57 | 2021-01-12 | nausea |
Patient received shot at 10:18 AM, started experiencing nausea at 11:09 AM, was administered epi-pen...
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Patient received shot at 10:18 AM, started experiencing nausea at 11:09 AM, was administered epi-pen at 11:30 AM followed by 50mg of benadryl. Noted that patient had headache, nausea, high blood pressure, trouble breathing and went by ambulance to ER
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| 57 | 2021-01-12 | diarrhea |
immediately after vaccination had flushed feeling. dizziness, and "jittery. diarrhea started 18 hrs ...
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immediately after vaccination had flushed feeling. dizziness, and "jittery. diarrhea started 18 hrs after
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| 57 | 2021-01-13 | nausea |
Adverse effect from the first shot was extremely tired and fatigued. Second shot migraine headache, ...
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Adverse effect from the first shot was extremely tired and fatigued. Second shot migraine headache, fatigued, body aches, nausea, pain throughout whole body.
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| 57 | 2021-01-13 | nausea |
Injection pain/tenderness at site, tiredness, HEADACHE, muscle pain, chills, joint pain, fever, nau...
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Injection pain/tenderness at site, tiredness, HEADACHE, muscle pain, chills, joint pain, fever, nausea, feeling body aches
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| 57 | 2021-01-13 | vomiting |
Positional vertigo and headache leading to vomiting lasting 9hrs total. I took meclizine, Tylenol, a...
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Positional vertigo and headache leading to vomiting lasting 9hrs total. I took meclizine, Tylenol, and Zofran 4hrs into symptoms which helped stop the progression.
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| 57 | 2021-01-13 | vomiting |
Positional vertigo and headache leading to vomiting. I took Tylenol, meclizine, and Zofran 4hrs i...
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Positional vertigo and headache leading to vomiting. I took Tylenol, meclizine, and Zofran 4hrs into the symptoms. This helped stop progression of the symptoms.
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| 57 | 2021-01-13 | nausea | Swollen injection site, muscle aches, fever (104), fatigue, mild nausea, swollen taste buds |
| 57 | 2021-01-13 | nausea |
exhausted/Exhausted like she could just lay down and go to sleep; Exhausted like she could just lay ...
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exhausted/Exhausted like she could just lay down and go to sleep; Exhausted like she could just lay down and go to sleep; freezing cold; slightly nauseous; not feel as zippy as she normally do; Arm hurting a little; This is a spontaneous report from a contactable consumer (patient herself, a dental hygienist) via Medical Information team. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EK5730, expiration date: Mar2021, NDC number was unknown), via an unspecified route of administration on the right arm (also reported as upper shoulder) on 07Jan2021 at 11:30 30 at a single dose for COVID-19 vaccination. The patient had no medical history. There were no concomitant medications. The patient reported she was feeling exhausted, freezing cold, slightly nauseous, and did "not feel as zippy as she normally do" on 08Jan2021. She wanted these effects recorded, and would like to know if they were normal, and would they happen to the same or higher intensity with the second dose. The patient further reported she had no adverse reaction on 07Jan2021 other than her arm hurting a little. Starting on 08Jan2021, she had felt exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous. She had been reading and was sure or was guessing this was normal, but wanted to verify that. She was not running a fever as of yet. Every time she tried to get up, she just laid back down. She felt fairly decent when she woke up, these events started later at the time of the report on 08Jan2021. She would not say these events were life threatening, but the CDC patient vaccine record card said to call to report any adverse events. She was scheduled for a second dose on 28Jan2021 and at this time did not plan to change dosing unless event worsening would occur. The patient had the vaccination, because she was always coming into contact with people with COVID at work. The patient had no investigation assessment. The reporter assessed the events as non-serious. The patient was recovering from the event "arm hurting a little," she was not recovered from the events "exhausted/exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous," while the outcome of the event "not feel as zippy as she normally do" was unknown.
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| 57 | 2021-01-13 | nausea, diarrhea |
throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Wa...
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throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Was pretty weak; This is a spontaneous report from a contactable nurse(patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration in the right arm on 17Dec2020 at single dose for covid-19 immunization; diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), both via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included high blood pressure from 2008 and ongoing. Concomitant medication included amlodipine from 2017 and ongoing at 5 mg at night for high blood pressure, losartan from 2017 and ongoing at 12mg once in the morning for high blood pressure. Following her 1st dose of the COVID vaccine on 17Dec2020, the patient had throat tightening, metallic taste in her mouth. She was scheduled to have her 2nd dose today (07Jan2021) and would like to know what to do and if she was still covered 80% from the 1st dose of her COVID vaccine shot. When she got her first COVID shot 3 weeks ago she got a metallic taste in her mouth and her throat tightened up a little. Throat tightening happened right after she got the shot and lasted about less than 2 minutes. She also turned red when she got it. Then about 14 hours later, on the same day she got nausea, diarrhea, and was pretty weak. This lasted until about 20Dec2020 as well. She was supposed to get 2nd dose today (07Jan2021). Before her first shot she had taken paracetamol and hydrochloride prior. She also took both of those today (07Jan2021). But then she was reading through the paperwork and it says that a severe reaction includes tightening of the throat. She was not sure if what she had was truly a reaction or not. She did not have other allergies. She had many flu shots and never had any difficulty with those. She was a nurse, she wanted the second dose, but she was concerned about the throat tightening, and it getting worse with the second dose. She was unsure of seriousness. She figured that she would get aches and pains. Everyone else who got it said their arm hurt, but nothing else. She thought it was weird. She was just wired differently she guesses. The action taken in response to the events for paracetamol and hydrochloride was unknown. The outcome of events throat tightening, turned red was recovered on 17Dec2020. The outcome of event metallic taste in her mouth, nausea, diarrhea, and was pretty weak was recovered on 20Dec2020.
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| 57 | 2021-01-14 | nausea |
Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt ...
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Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt swollen, especially the right. Within a few more hours my arm became heavy and I had some general muscular achiness. By approximately 11pm I had intense muscular pain on the back of my legs making it difficult to stand. It felt like I had been hit repeatedly with 2x4s. About that time my posterior ribcage hurt also. I couldn't sleep, turning frequently as my hips hurt. This is what I felt like when I had COVID. Intense pain. At 0630 (1/14) I got out of bed and felt I was going to faint, was extremely nauseous (I did not vomit) and had a very bad, global headache. I had to lay down again. My temp was 100.1 orally. I could not go to work. I was able to take Tylenol. It helped the pain but two hours later my temp was 100.8. I could not get out of bed until 6pm, I felt delirious when I tried. I was able to go to work on 1/15. Of note, following my first dose of COVID vaccine (Pfizer BioNtech Lot #EH9899 on 12/23/20) I had site soreness, heaviness of my left arm, T of 99.5 same day (about 10-12 hours post vaccination), and mild body aches for about a day.
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| 57 | 2021-01-14 | abdominal pain upper |
Headache, slight dizziness and stomach cramping started later that day of vaccination. Stomach cramp...
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Headache, slight dizziness and stomach cramping started later that day of vaccination. Stomach cramping and Headaches continued intermittently. I took Excedrin as needed for symptoms. Itchiness started after a week and rash developed on 1/14/2021. I am waiting for return call from my Primary Doctor. I started taking Benadryl 25mg for rash/itchiness as needed.
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| 57 | 2021-01-14 | nausea, diarrhea |
low grade fever Shakes Cold numb hands fingers blanch white blood pressure drop 70/40 severe body ac...
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low grade fever Shakes Cold numb hands fingers blanch white blood pressure drop 70/40 severe body aches diarrhea nausea
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| 57 | 2021-01-15 | nausea, vomiting, abdominal pain |
Day after 2nd shot fatigue Day 4 after 2nd shot mild and pain Day 5, woke up 3 am, severe abd pain,...
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Day after 2nd shot fatigue Day 4 after 2nd shot mild and pain Day 5, woke up 3 am, severe abd pain, unable to sleep, vomited once, took Tylenol, went to walk in at 7 am, did blood work, urine and Covid screen, all normal and negative, pain improved after about 15 hours Day 6 , today, pain came back, mild at 10 am and then severe at 11, nausea, vomited once, took Tylenol at 11 and feels better but still quite uncomfortable. Able to drink, normal stool, no other symptoms
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| 57 | 2021-01-16 | vomiting, nausea |
injection site (immediate), headache, chills, nausea, slight fever (within 12 hours), vomiting (with...
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injection site (immediate), headache, chills, nausea, slight fever (within 12 hours), vomiting (within 24 hours). All symptoms disappeared within 36 hours.
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| 57 | 2021-01-17 | nausea | 1/10/21 runny nose, congestion, fever, HA, cough, nausea, chills, body aches |
| 57 | 2021-01-18 | nausea, nausea |
Arm soreness Migraine headache Nausea Hot and cold Fatigue Unsure of fever Numbness and tingling in ...
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Arm soreness Migraine headache Nausea Hot and cold Fatigue Unsure of fever Numbness and tingling in both hands
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| 57 | 2021-01-18 | nausea |
Patient experienced hypertension, dizziness, nausea, thick secretions in throat, and itchy throat. W...
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Patient experienced hypertension, dizziness, nausea, thick secretions in throat, and itchy throat. Was treated with a single dose of Dexamethasone 10 mg IV. Symptoms resolved and patient was sent home.
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| 57 | 2021-01-18 | nausea | Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Nausea-Mild |
| 57 | 2021-01-18 | nausea, diarrhea |
slight nausea; dizziness; body weakness; 3 types of diarrhea; I have been sick ever since; I am not ...
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slight nausea; dizziness; body weakness; 3 types of diarrhea; I have been sick ever since; I am not able to work; chills; 102.9 F/low-grade temperature (99.2-99.8 F); This is a spontaneous report from a contactable nurse. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had side effects that are "fluctuated but up until now". She had 1 episode of chills (102.9 F), slight nausea, low-grade temperature (99.2-99.8 F) almost everyday, dizziness, body weakness, 3 types of diarrhea, starting to resolve, most concerned (lasting almost 11 days now). The patient received the first COVID vaccine on 29Dec2020 and she has been sick ever since. Patient was negative for COVID. She already sought help from doctor and went to the ER last night. She had slight to moderate symptoms and not fully recovered. She was not able to work. She was relating this to the vaccine as she was fine before. She went travelling back in March and became ill. They were not testing for COVID back then and she recovered. I wonder if I had COVID back then. She was glad it is her turn. She has been waiting a long time. It has been a concern. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses are expected for most people. On 30Dec2020 she had chills and temperature of 102.9. That subsided by taking Tylenol and rest. After that she felt sick like headache, dizziness, and low-grade temp until now. She hasn't been back to work. She has already sought advice from her doctor. She went to the ER last night to make sure she is ok because it was not resolving. Her COVID test was negative two days ago. Before the COVID shot she was healthy, working, and no symptoms of anything. After the shot, all this. Patient then asked if anyone else experienced these and if these were vaccine related. She would like to know what to do to confirm it was vaccine, how long will she be off work. The ER doctor said that she could have had the virus before she had the shot or after, but it is a slim chance now that she is COVID negative. Before she knew if she was COVID negative or positive, she went on the website and filled it out. Now that she has confirmed that she is negative what could cause this illness after the shot. She did that before she knew she was COVID negative. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses is expected for most people. Outcome of the event "102.9 F/low-grade temperature (99.2-99.8 F)" and chills was recovered, while outcome of the other events was unknown. Information on batch/lot number has been requested.
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| 57 | 2021-01-19 | diarrhea, nausea |
Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday...
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Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday; Slight nausea; Some dizziness; Headaches; Slight body weakness; Diarrhea 3x since; Unable to work; Not completely well to function daily chores and activities; This is a spontaneous report from a contactable nurse reporting for herself. This 57-year-old female patient received on 29Dec2020 11:00 am first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140) at single intramuscular in the left arm for COVID-19 immunization. Medical history included hypertension, asthma, Type 2 diabetes mellitus, high cholesterol. The patient had an allergy with lisinopril. Concomitant medication included hydrochlorothiazide, atenolol, lovastatin, fenofibrate, melatonin, colecalciferol, ascorbic acid, tocopherol, acetylsalicylic acid (ASPIRIN 81). Starting from 30Dec2020, the patient had chills, 102.9 F once, but ever since she was having low grade temps 99.2 99.9 F even to 100.4 F almost every day and came in the late afternoon or evening, slight nausea, some dizziness, headaches, slight body weakness, had episode of diarrhea 3x since, and it was still on going for almost 11 days now. Unable to work. I was mobile at home but not completely well to function daily chores and activities. No treatment was provided. Outcome was not recovered. On 08Jan2021 the patient had a nasal swab with an unknown result.
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| 57 | 2021-01-19 | abdominal pain |
Developed fever and headache after receiving vaccine. 1st vaccine had fever after 72 hours, develope...
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Developed fever and headache after receiving vaccine. 1st vaccine had fever after 72 hours, developed cold symptoms and intestinal issues after 6 days. 2nd vaccine fever developed 26 hours after receiving, now 28 hours later having aches and headache and abdominal pain.
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| 57 | 2021-01-19 | abdominal pain, nausea, diarrhea | Fever 101, abdominal cramps, diarrhea, nausea. |
| 57 | 2021-01-19 | nausea, vomiting |
Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, f...
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Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, face turned pale for few mins, hyperventilating
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| 57 | 2021-01-19 | nausea |
Temperature 99.3; nausea; headache; body aches; fatigue; left hip pain; This is a spontaneous report...
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Temperature 99.3; nausea; headache; body aches; fatigue; left hip pain; This is a spontaneous report from a contactable healthcare professional (patient) reported for herself that a 57-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685), via intramuscular at left arm, on 31Dec2020 12:30, at single dose for COVID-19 immunisation. Medical history included ongoing chronic fatigue syndrome, fibromyalgia, sun allergy and lactose intolerant (allergy). Concomitant medications were not reported. Patient did not have COVID prior vaccination. Patient did not receive other vaccine in four weeks nor other medications in two weeks. The patient experienced temperature 99.3, nausea, headache, bodyaches, fatigue, left hip pain, all on 01Jan2021 15:45, no treatment was received for events. Patient did not test COVID post vaccination. Outcome of the events was recovered in Jan2021.
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| 57 | 2021-01-20 | nausea | Chills, fever, headache, nausea, sweats. Arm sore and red at injection site. |
| 57 | 2021-01-20 | nausea | Elevated BP 200/120 known history of hypertension. Headache, Nausea and headache |
| 57 | 2021-01-20 | nausea |
Heaviness in legs with muscle tightness/soreness, slight temporal headache, sore L UE at injection s...
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Heaviness in legs with muscle tightness/soreness, slight temporal headache, sore L UE at injection site, some nausea later in the day.
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| 57 | 2021-01-21 | nausea |
1/14/21 9pm chills 1/15/21 8am chills, muscle aches, headache, nausea, fatigue, rigors low grade fe...
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1/14/21 9pm chills 1/15/21 8am chills, muscle aches, headache, nausea, fatigue, rigors low grade fever. 2 pm temp 100.8, bilateral ear drum pain 1/16/21 8 am fatigue. 1/17/21 2am woke up with chills nausea and ear pain. 1/17 in morning fatigue . 1/18/21 asymptomatic.
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| 57 | 2021-01-21 | nausea | Arm, Neck pain & severe nausea |
| 57 | 2021-01-21 | vomiting |
Patient self-reported through the hospital adverse drug reaction reporting system. Pt. received the...
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Patient self-reported through the hospital adverse drug reaction reporting system. Pt. received the second dose of COVID-19 vaccine on 1/20/21 @ 0742. After receiving the second dose, Pt. reported around 1700 the onset of "severe headache, joint pain, vomiting, and a Temp of 101.7 degrees F".--patient's own words and description.
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| 57 | 2021-01-24 | nausea |
Approximately 48 hrs. after 1st dose on 1/22/21, body aches, especially the back muscles and nausea....
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Approximately 48 hrs. after 1st dose on 1/22/21, body aches, especially the back muscles and nausea. Also headache.
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| 57 | 2021-01-24 | vomiting |
Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contacta...
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Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer for herslf. A 57-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EL1284) vaccine , intramuscular in the right arm on 30Dec2020 10:30 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. Since 03Jan2021, the patient has been sick. Her fever started out at 99.7 degrees Fahrenheit with a terrible cough and then it just kept getting worse. This weekend it was 102.7 degrees Fahrenheit all weekend. Her cough improved. She took some Delsyn one day. The cough improved but is not gone away. Headaches started on day 4 or 5. Lot of pressure in forehead and eyes. Fever kept going up day after day been up to 101.2°F and then up 102.7°F all weekend. Then she just felt weak all weekend. Just walking to bathroom is short of . Yesterday fever was 101.5°F and she went to doctor and they did a rapid COVID test and it came back positive. Slept a lot more this weekend. Done nothing but slept. She did not think it would make her this sick. only vomited once. she is supposed to get second dose on Saturday. She is afraid to get second. The patient also reported the following information: Fever 08:30 Terrible Cough 08:30 Headache 10:00 Weakness 12:00 Shortness of breath when walking 12:00 Increased sleepiness 12:00 Positive for Covid 09:21 Diarrhea 08:00 Vomiting 14:00 The patient underwent lab tests and procedures which included body temperature: 99.7 Fahrenheit; 102.7 Fahrenheit; 101.2 Fahrenheit then up 102.7 Fahrenheit ; 101.5 Fahrenheit. Sars-cov-2 test: positive on 11Jan2021 . Further information has been requested
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| 57 | 2021-01-24 | nausea, diarrhea | Nausea, diarrhea, chills |
| 57 | 2021-01-24 | nausea, vomiting | Nausea, vomiting , cold sweats , throat warm, lethargic fatigue. |
| 57 | 2021-01-25 | diarrhea |
Diarrhea; This is a spontaneous report from a contactable health professional (reported for herself)...
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Diarrhea; This is a spontaneous report from a contactable health professional (reported for herself). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 14Jan2021 (07:30 AM) at single dose for Covid-19 immunization. The patient's medical history included psoriatic arthritis, seizure disorder, and allergy to latex. Concomitant medication included esomeprazole sodium (NEXIUM). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced diarrhea on 15Jan2021 (06:00 AM). There was no treatment received for the adverse event. The outcome of event was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 57 | 2021-01-25 | nausea | Episode of Nausea,Elevated BP 207/100 1 Hour following Vaccine administration |
| 57 | 2021-01-25 | nausea | Slight HA, exhausted, leg heaviness, nausea, resolved by the end of the day |
| 57 | 2021-01-25 | decreased appetite |
Soreness at injection site; joint pain; muscle pain; chills; Loss of appetite; Low-grade fever; This...
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Soreness at injection site; joint pain; muscle pain; chills; Loss of appetite; Low-grade fever; This is a spontaneous report from a contactable other hcp. A 56 year old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number:EH9899), intramuscular on the left arm on 21Dec2020 09:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known_allergies: Sulfa drugs. Concomitant medication included progesterone (PROGESTERONE), estradiol (ESTRADIOL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced soreness at injection site, joint pain, muscle pain, chills, low-grade fever and loss of appetite on 21Dec2020. The outcome of the events was recovered.
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| 57 | 2021-01-25 | difficulty swallowing |
Starting itching, then face and lips started tingling. Took Benadryl and Pepcid. Next morning starte...
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Starting itching, then face and lips started tingling. Took Benadryl and Pepcid. Next morning started having difficultly swallowing, went to ER-1-6-21 On 1-7-21 started itching from all over, blood pressure was 262/106, went back to ER
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| 57 | 2021-01-25 | vomiting, nausea |
Woke up vomiting. Thought maybe it was something to do with the lobster I had for dinner the night ...
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Woke up vomiting. Thought maybe it was something to do with the lobster I had for dinner the night before. Vomiting continued throughout the day Thursday. Started to think maybe it was flu bug. I also had constant headache which I thought was from vomiting but it wouldn't go away. I had no other flu symptoms though either. Vomiting stopped on Friday am but nausea continued with headache and is still present today, 01/26/2021. Nausea is gone now. No other symptoms or issues.
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| 57 | 2021-01-25 | nausea, diarrhea, vomiting |
chills fever (evening) nausea vomiting (1x) diarrhea (3 days) body aches dizziness weakness tired fe...
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chills fever (evening) nausea vomiting (1x) diarrhea (3 days) body aches dizziness weakness tired feeling
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| 57 | 2021-01-26 | nausea |
Nausea, body aches, headache, exhaustion, pain in left armpit/axillary area started 2 days post inje...
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Nausea, body aches, headache, exhaustion, pain in left armpit/axillary area started 2 days post injection, pain and tenderness around injection area.
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| 57 | 2021-01-27 | diarrhea, abdominal discomfort |
Developed shortness of breath, chest tightness and cough in addition to severe fatigue, sore throat,...
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Developed shortness of breath, chest tightness and cough in addition to severe fatigue, sore throat, joint/muscle pain, nausea and abdominal discomfort with diarrhea. Fatigue, fever, joint/muscle pain began the next day. Shortness of breath, chest tightness, cough and sore throat started on the second day after receiving the vaccine. Fever resolved by day 3. Shortness of breath, chest tightness, sore throat and cough resolved on the 6th day. Fatigue, muscle/joint pain resolved by day 7. Developed nasal congestion by day 5 which resolved on day 10. Treatment was rest, fluids, Tylenol, and Claritin.
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| 57 | 2021-01-28 | abdominal pain upper |
COVID-19 Vccine stomach aches, low fever, headaches, general malaise for 3 days. Currently, I am ...
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COVID-19 Vccine stomach aches, low fever, headaches, general malaise for 3 days. Currently, I am still having stomach aches all day/night.
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| 57 | 2021-01-28 | vomiting, nausea |
Woke up Sunday morning with vertigo. The room kept spinning the whole day with nausea and vomiting...
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Woke up Sunday morning with vertigo. The room kept spinning the whole day with nausea and vomiting. Took Meclizine. Could not stand or eat. Monday still extremely tired could not hold my head up and still dizzy but room was not spinning. Tuesday a little better than Monday. Wed, Thur and Friday was able to function tired easily and was afraid to drive with occasional dizziness.
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| 57 | 2021-01-31 | nausea | Headaches with Chills and Nausea. Fatigue Tylenol Helpful for a short duration. |
| 57 | 2021-01-31 | nausea | PFIZER-BIONTECH COVID-19 VACCINE EUA COUGHING, RUNNY NOSE, CONGESTION, BODY ACHES MILD HA & NAUSEA |
| 57 | 2021-01-31 | vomiting |
The next morning after vaccine, patient ran a fever, vomited, and was very tired. Mom laid her down...
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The next morning after vaccine, patient ran a fever, vomited, and was very tired. Mom laid her down to sleep and when she checked later, patient had passed away.
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| 57 | 2021-02-01 | abdominal distension |
GI reaction with spasms; GI reaction with spasms; bloating and uncomfortable like you over eat and h...
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GI reaction with spasms; GI reaction with spasms; bloating and uncomfortable like you over eat and have tight pants in; bloating and uncomfortable like you over eat and have tight pants in; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at 04:30PM in left arm at single dose for COVID-19 immunisation at the age of 57-year-old. Lot number was 59267-1000-01. Medical history included no gall bladder, ongoing bloating and uncomfortable like you over eat and have tight pants in on 11Jan2021 at 02:00PM. Patient was not pregnant. Past drug history included allergy to codeine. Concomitant medications included venlafaxine, verapamil, tocopherol (VITAMIN E), ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM), atenolol (ALTENOL), zopidem tartrate (ZOLPIDEM). On 11Jan2021 at 02:00PM (also reported: wishing 2 minutes, as reported), inside stomachs and gut, the patient felt it spread over that area (not warm, not painful, weird) and afterwards that night bloating and uncomfortable like you over eat and have tight pants in, then the next day (on 12Jan2021, also reported on 11Jan2021 at 02:00PM, as reported) she had a gastro-intestinal (GI) reaction with spasms that were very painful (something that happens very seldom and the patient was sitting at her desk working so no irritable factors) so she had to take strong meds because this GI spasm was very painful and hurt when you breath, so she took strong medication (hyosymin and mepitab). The patient recovered with lasting effects from abdominal distension, the patient recovered from other events.
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| 57 | 2021-02-03 | nausea, vomiting | CAME TO WORK FEELING OK, AFTER EATING BREAKFAST STARTED FEELING DIZZY AND NAUSEATED AND VOMITED |
| 57 | 2021-02-03 | decreased appetite |
she may have already had COVID 19 with the symptoms she has now; she may have already had COVID 19 w...
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she may have already had COVID 19 with the symptoms she has now; she may have already had COVID 19 with the symptoms she has now; was feeling bad; she lost her taste and her smell; she lost her taste and her smell; tired; sleeping all the time; she is sick; She still hasn't eaten a whole meal since Friday; not able to eat; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL0142, exp date not reported), intramuscular (by injection once left arm, below shoulder blade in muscle) on 13Jan2021 for COVID-19 immunization (because of job). Medical history included two stroked from 1998 and 2005. Concomitant medication included oral donepezil started taking 3 months ago (Oct2020) for something having to do with muscles because of stroke. She takes a blood thinner, as she had 2 strokes; and takes muscle relaxers too. By 15Jan2021 (Friday morning) the patient was feeling bad, she couldn't go to work, she lost her taste and her smell, part of smell. Part of taste was back at the time of reporting, but she was tired and sleeping all the time (onset date reported as 15Jan2021). She saw her neurologist because she had 2 strokes, they referred her to Pfizer, as they said she may have already had COVID 19 with the symptoms she has, but as far as she knows, she didn't have it, she took a test with the center a month before giving the vaccine, she took the vaccine because of her job, because of the kind of job she has, and they wanted her to let Pfizer know she was sick. She doesn't know if she wanted to get the other dose, as she was not feeling well at all. She was laying down sleeping every day. Her doctor said to tell Pfizer what was going on. She still doesn't feel good the day of reporting. She still hasn't eaten a whole meal since 15Jan2021. She thinks she was probably getting better, but was getting better slowly, she has no taste, she was not able to eat, no smell at all, which was really not a good thing. She can't tell the outcome of no smell she thinks. She can't smell nothing at all. She can't smell what she was cooking. It was the same as taste, she thought that is probably why she can't eat, she can't taste what she was eating. Taste was improved, but not well enough for her, it is hard to explain, you know how you enjoy food, like how it tastes, and if you can't taste, you can't eat. She sleeps all day, she was up now, but is probably going to go to sleep, she feels tired and needs to lay down. She told her doctor she will call and see what Pfizer says, they will go from there. She doesn't know if she will have to go see if she has COVID 19, or what was going on. No further investigation assessment was performed. The patient took a test a month before (results unknown). No taste was recovering (ongoing at the time of reporting) while outcome of other events was not recovered.
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| 57 | 2021-02-04 | nausea | Severe dizziness, headache, nausea on 8th day following vaccine. |
| 57 | 2021-02-05 | nausea |
Fever of 100, nausea, injection site pain, lympnoid pain right side into right breast, stiff neck, ...
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Fever of 100, nausea, injection site pain, lympnoid pain right side into right breast, stiff neck, all over pain ,achness, headache, fatigue and all over chills. Took tylonal and went to bed for 14 hours. Still experiencing pain, slight headache and achness all over. Fever and nausea gone.
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| 57 | 2021-02-05 | diarrhea | Slight headache, diarrhea, fatigue |
| 57 | 2021-02-09 | nausea |
103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it wa...
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103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it was burning; This is a spontaneous report from a contactable nurse reported for herself. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) by injection once to right deltoid on 25Jan2021 at single dose for COVID-19 immunization. Medical history included she had COVID, she was diagnosed, was positive on 29Dec2020, and spent 9 days in the hospital. concomitant mediation was none. Patient calling about the COVID vaccine; her boss texted, she had to leave work, she had a 103.5 fever (26Jan2021), she felt horrible, she got her first COVID vaccine yesterday, and woke up this morning and felt horrible. a girl touched her arm, said it was burning, and she was very nauseous, and was trying to pass meds, and took her temperature and it was 103.5, and the thing is when you come into the facility, they took her temperature and it was 97.2, but those thermometers suck and she has an oral thermometer, and it was 103.5. It's improving. Also has severe back pain and body aches, she was scared with the fever. Felt nauseous this morning (26Jan2021), had chicken noodle soup and crackers, but it was pretty bad to point she had to pull the trash can behind her. she was on a ventilator in March for a week, not with COVID, she doesn't want to die, she thought she was going to die with COVID, she had every symptom. No Investigation Assessment. The last outcome of 103.5 fever, nausea and severe back pain was recovering, body aches was not recovered, outcome of other events was unknown. Reporter seriousness for 103.5 fever was Medically significant. For severe back pain, body aches and Nausea was Not serious. Relatedness of drug to reactions/events 103.5 fever, severe back pain, body aches and Nausea per source of assessment of Primary Source Reporter and Method of assessment of Global Introspection with drug result of Related.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event pyrexia and remaining events cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-09 | nausea | Headache beginning 2/9 around 16:30 with nausea beginning 2/10 am. |
| 57 | 2021-02-09 | nausea |
Joint pain; Nausea; This is a spontaneous report from a contactable consumer (patient). A 57-years-o...
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Joint pain; Nausea; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1283), via an unspecified route of administration at Left arm on 22Jan2021 11:45 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included duloxetine. The patient was not pregnant. No known allergies. The patient experienced joint pain and nausea on 24Jan2021 10:00. No treatment received for the events. No COVID prior vaccination. Nasal Swab performed on 25Jan2021, but result was pending. The outcome of the events was not recovered.
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| 57 | 2021-02-09 | nausea |
her upper chest, the medial aspect of her left arm and down her upper arm initially pain; her upper ...
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her upper chest, the medial aspect of her left arm and down her upper arm initially pain; her upper chest, the medial aspect of her left arm and down her upper arm initially pain/fingers ached; down her upper arm initially pain; About 15 minutes later her wrist and fingers ached/joint pain; a gradual increase of body aches; nausea; feeling 'hot'; Big time tired, fatigue the patient would go to bed early; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration at Arm Left on 25Jan2021 14:15 at the 57 years old at single dose for COVID-19 immunization. The medical history included FAP (Familial adenomatous polyposis), hernia repair, ankylosing spondylitis, bipolar disorder II, chronic depression, PTSD(Post-traumatic stress disorder), anxiety, GERD, Penicillin allergy, Adhesive tape allergy, Antiemetics allergy. The concomitant medications were amlodipine, ASA, HCTZ, lamotrigine (LAMICTAL), losartan, naproxen. The patient previously took Ciprofloxacin and experienced allergy, Ativan and experienced allergy. Right after the patient received the shot on 25Jan2021 14:30, her left side of her upper chest, the medial aspect of her left arm and down her upper arm initially pain. About 15 minutes later her wrist and fingers ached. From then on 25Jan2021 14:30, a gradual increase of body aches and joint pain, some nausea feeling 'hot' but not 'hot flashes' no sweats, Big time tired, fatigue the patient would go to bed early. She was keeping very hydrated. There was no other vaccine in four weeks. There was no treatment for the adverse events. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the events was recovering. Information about lot/batch number has been requested.
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| 57 | 2021-02-09 | decreased appetite, nausea |
sore arm (briefer than with #1); malaise; fatigue; Pulsing tinnitus, eased off now; bad headache (pr...
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sore arm (briefer than with #1); malaise; fatigue; Pulsing tinnitus, eased off now; bad headache (prexisisting but markedly amplified-still; chills (no fever, 3 days for real, now fading); mild nausea/loss of appetite (largely resolved.); mild nausea/loss of appetite (largely resolved.); This is a spontaneous report from a contactable Physician reported for herself. This 57-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 09Jan2021 09:00 AM on Arm left at single dose (Lot # EK9231) for covid-19 immunisation. Medical history included Pacemaker, Insomnia, and some preexisting hearing loss, due to effusion. No known allergies. No covid prior vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 16:45 PM on Left arm at single dose (Lot # EH9899) for covid-19 immunisation. Covid test after #1 (December) due to sore arm, chills, aches and malaise. Was negative. No other vaccine in four weeks. Concomitant medications included other medications in two weeks. The patient experienced pulsing tinnitus, eased off now, also sore arm (briefer than with #1), malaise/fatigue (still but better), bad headache (persisting but markedly amplified-still, chills (no fever, 3 days for real, now fading), mild nausea/loss of appetite (largely resolved.) Events all on 10Jan2021 06:00 AM. Lab data included covid test (Nasal Swab) on 22Dec2020: negative. No treatments were received for the events. Outcome of events mild nausea/loss of appetite, malaise, fatigue was recovering. Outcome of the event chills (no fever, 3 days for real, now fading) was recovered. Outcome of the events was unknown.
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| 57 | 2021-02-10 | nausea, decreased appetite, abdominal pain upper |
rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp...
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rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp remaining at 95 degrees; stomach pain; dizziness; weakness; severe fatigue; severe headache; nausea; injection site pain; lack of appetite or thirst; lack of appetite or thirst; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date was not reported), intramuscular on 07Jan2021 15:30 at single dose on the left arm for covid-19 immunization. Medical history included PTSD, CRPS, anxiety, and chronic pain. The patient has no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and clonazepam. On 21Jan2021 at 16:00, the patient experienced severe chills and hot flashes with temp remaining at 95 degrees, stomach pain, dizziness, weakness, severe fatigue, severe headache, nausea, injection site pain, lack of appetite or thirst. On 26Jan2021, the patient experienced rectal bleeding (medically significant). It was reported that the patient received Zofran and she missed her work days. The patient had a clinic visit to her doctor. It was reported the patient was not diagnosed with COVID-19 prior to vaccination. The patient had Nasal Swab on 25Jan2021 with negative results. The patient has not recovered from all of the events at the time of the report.
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| 57 | 2021-02-12 | diarrhea |
Fever, Diarrhea, 1/20/21 SYMPTOMS BEGAN. ADMITTED TO HOSPITAL & CONTACTED EOH 1/27/21 WITH FEVER, CH...
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Fever, Diarrhea, 1/20/21 SYMPTOMS BEGAN. ADMITTED TO HOSPITAL & CONTACTED EOH 1/27/21 WITH FEVER, CHILLS,SOB, COUGH., DIARRHEA, BLOOD CLOTS, FLUID AROUND HEART. Narrative: Other Relevant History:
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| 57 | 2021-02-14 | decreased appetite |
diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feelin...
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diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feeling; slept all day long/; poor appetite/No appetite; slept all day long/Had no energy; severe aches; woke up with 102° temperature; diagnosed with strep; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 57-years-old non-pregnant female patient (nurse) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), intramuscular in the left arm on 06Jan2021 at 16:30 as a single dose, Lot number Unknown for COVID-19 vaccination. The patient medical history was not reported. The patient has no know Allergies to medications, food, or other products. Concomitant medication included levothyroxine (LEVOTHYROXINE), alprazolam (XANAX). On 07-JAN-2021 at 12:00, the patient experienced diagnosed with Covid, sore arm, more tired/very fatigue, overall unwell feeling, slept all day long, poor appetite/no appetite, slept all day long/had no energy, severe aches, woke up with 102° temperature, diagnosed with strep. Adverse event start date was reported as 07JAN2021 at 12:00 PM However, the consumer reported the sequence of events as follows. Morning after the vaccination patients complaint was a sore arm. As the day proceeding, She became more tired. The following day was Friday. Very fatigue overall unwell feeling. On the weekend, Saturday and Sunday slept all day long. Had no energy. Very poor appetite. Once again overall unwell. Was able to work approximately half days on Monday Tuesday and Wednesday. She work Hospice and did enter a facility with known positive cases but was in Full PPE with every precaution as per my norm. On Thursday in the a.m. early she woke up with 102° temperature and severe aches. Was seen at the local urgent care and diagnosed with Covid. The adverse event result in Emergency Room Visit and Physician Office Visit The patient underwent lab tests and procedures which included body temperature of 102 on 07Jan2021 and ,SARS-CoV-2 test ( Nasal Swab) Positive on 14Jan2021. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Treatment received for the events were unknown but it was also reported 'she is on second round of antibiotics And steroids. Numerous exposures over last 10 month'. The clinical outcome of the events Covid-19, sore arm, more tired/Very fatigue, overall unwell feeling, Sleep excessive, poor appetite/No appetite, slept all day long/Had no energy, severe aches, fever was recovering; while Drug ineffective was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. ,
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| 57 | 2021-02-16 | nausea |
numbness around vaccine site. nausea. typical reaction she has with vaccines. feels better after...
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numbness around vaccine site. nausea. typical reaction she has with vaccines. feels better after 10 mins
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| 57 | 2021-02-19 | decreased appetite, abdominal pain |
Slight Abdominal pain 0400 2/2/21. Loss of appetite. Severe abdominal pain 1400. Went to ER. Surgery...
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Slight Abdominal pain 0400 2/2/21. Loss of appetite. Severe abdominal pain 1400. Went to ER. Surgery and ruptured appendix 2/2/21 at 2130. Resulting in peritonitis, seven day hospital stay, multiple antibiotics, elevated abnormal labs including LFT and platelets. ,
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| 57 | 2021-02-20 | diarrhea, vomiting |
She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness...
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She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness, dyspnea, diarrhea, vomiting and fever. She required hospitalization on 1/18/21 for Acute hypoxic respiratory failure secondary to bilateral Pneumonia with left pleural effusion. Sepsis secondary to Gram-Positive bacteremia (strep pneumococcus). UTI. Acute Kidney Injury
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| 57 | 2021-02-21 | abdominal pain |
Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours,...
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Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours, Extreme fatigue-5 days, Chills-8 hours, Fever-3 days (reducing in severity each day), arm pain in shot area- mild and continuous for 6 days.
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| 57 | 2021-02-22 | difficulty swallowing |
Approximately 10 minutes after vaccination (during post vaccination observation), patient reported f...
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Approximately 10 minutes after vaccination (during post vaccination observation), patient reported feeling ?off? and that her throat hurt. I was contacted via radio to aid with assessment. Upon my arrival, patient reported that that she was experiencing slight difficulty swallowing, was feeling ?off? and felt ?like her head was in a fog?. Assessment of vitals revealed an intial vital signs of respiration rate of 18 breaths per minute, pulse of 74 beats per minute, 97% oxygen saturation levels. Blood pressure was obtained prior to arrival and was reported as 121/74. Lungs were clear to auscultation bilaterally. Clear S1 and S2 were present upon cardiac auscultation with no mumurs or gallops noted. Patient appeared slightly pale with a slightly hoarse voice. Patient did not have noticeable pharyngeal edema upon examination. Patiney had no increased work of breathing and was not using accessory Muscles for breathing. Patient was given a swallow test using bottled water and then solid food and demonstrated intact ability to swallow with no regurgitation, choking or drooling noted. Continuous oxygen saturation monitoring revealed 02 that never fell below 96%. Continuous pulse monitoring revealed a pulse that was between 74-79. Given the stability the vital signs, demonstrated ability to swallow and inappropriately labeled IM medication in emergency kit (ie three loose syringes were not drawn up by myself. Medications were labeled by hand with no expiration date, route or dose), I elected to give the patient 25 mg of oral diphenhydramine. Patient declined to seek emergency medical attention several times. Patient?s daughter was then called so that the patient could be driven home. Patient was advised to seek emergency medical attention if her symptoms worsened, she developed increased difficultly breathing or otherwise felt unwell. Advised to follow up with PCP within next 24 hours.
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| 57 | 2021-02-22 | nausea, diarrhea | Nausea, diarrhea, headache |
| 57 | 2021-02-22 | nausea |
Very Bad nausea, Severe Vertigo, Bad Headaches, Blurred vision I was hospitalized at Hospital for 1...
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Very Bad nausea, Severe Vertigo, Bad Headaches, Blurred vision I was hospitalized at Hospital for 1.5 days. But the fields in question 21 would not allow me to enter the information when I checked Hospitalization. I received the vaccination at the Stadium in which was a State run POD.
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| 57 | 2021-02-23 | diarrhea, abdominal distension, abdominal pain, indigestion |
Days 1-3 pain at site of injection much more than other vaccines that subsided but to this date has ...
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Days 1-3 pain at site of injection much more than other vaccines that subsided but to this date has not gone away completely. Low grade fever and fatigue for about a week, lots of sleeping! Mild wheezing and sinus congestion, headaches. Day 4 I developed swelling in the lower legs and feet, that lasted about a week, still some fatigue and ongoing sinus congestion but feeling better, then a few days later in the 2/16 developed sudden onset moderately severe pain and tenderness in the upper right abdominal quadrant in the area of the live, gallbladder and pancreas up near and under the ribs and around to the flank and a small aspect of the back, with abdominal swelling belching and bile diarrhea and indigestion
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| 57 | 2021-02-23 | vomiting, nausea | Fever, chills, headache, joint pain, nausea, vomiting |
| 57 | 2021-02-24 | nausea, abdominal pain upper |
General fatigue, severe swelling in arm with pain, hives on scalp with horrible itching, diarrhea, s...
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General fatigue, severe swelling in arm with pain, hives on scalp with horrible itching, diarrhea, stomach pain, severe back pain, nausea.
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| 57 | 2021-02-24 | nausea |
Sore arm within two hours. Some fatigue and slight headache and slight nausea within the first 24 ...
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Sore arm within two hours. Some fatigue and slight headache and slight nausea within the first 24 hours. All very minimal. Fever, chills, bad headache, sweats, general discomfort beginning around 24 hours after shot. Fever subsided 36 hours after shot. Headache persisted for over 48 hours. Some nausea between 48 hours and 72 hours after shot. Fatigue and haziness throughout.
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| 57 | 2021-02-26 | nausea | Nausea, hot flashes, cleared by medic |
| 57 | 2021-02-27 | nausea |
Lightheaded and dizzy. Became nauseaous and 2 hours after onset, got sick. Slight fever and chills...
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Lightheaded and dizzy. Became nauseaous and 2 hours after onset, got sick. Slight fever and chills. Dizziness lasted about 2 more hours after getting sick. Then just fatigue for the rest of the day. Only slight fatigue and achiness the next day.
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| 57 | 2021-02-28 | diarrhea, nausea | Nausea ( 3 days) and diarrhea (1 day) |
| 57 | 2021-03-03 | diarrhea, nausea |
Diarrhea; Chills; Cough; Sneezing; Nausea; This is a spontaneous report received from a contactable ...
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Diarrhea; Chills; Cough; Sneezing; Nausea; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: unknown), via an unspecified route of administration on the left upper arm, on 30Jan2021, at single dose, for COVID-19 immunization, at a nursing home. Medical history included ongoing allergies which the patient was diagnosed before having the vaccine. There were no concomitant medications. The patient did not receive prior vaccinations within 4 weeks. On 30Jan2021, 2 hours after the vaccination, the patient experienced nausea. On 31Jn2021 at 03:00, the patient experienced chills, was coughing and sneezing. She stated that she was not coughing constantly, and it comes off and on. On 02Feb2021, the patient experienced diarrhea. She called her doctor and treatment included Tylenol and inhaler if needed. Her doctor would not give her prednisone so her lungs could get strong. The patient stated that she was scheduled to get her second dose on 20Feb2021. The patient recovered from nausea on 31Jan2021; was recovering from chills, cough and sneezing; and has not recovered from diarrhea.
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| 57 | 2021-03-03 | decreased appetite |
reports having soreness in left arm at site of injection site. developed loss of appetite that afte...
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reports having soreness in left arm at site of injection site. developed loss of appetite that afternoon after receiving vaccine. noticed shortness of breath while walking the dog. sunday evening, developed left axillary lymph node swelling. also with fever 99.8 - 100.2 degrees F. had night sweats saturday evening (2/27/2021 PM). also with headache after vaccine.
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| 57 | 2021-03-04 | diarrhea | Diarrhea for 24 hours |
| 57 | 2021-03-05 | difficulty swallowing |
I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble sw...
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I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble swallowing. Fever escalated to 103 at 1am 3/3. By 9am 3/3 neck was much more swollen and swallowing more difficult. By 3/4 fever down to 101.3 but throat so swollen difficult to talk, drink, unable to eat. Went to ER at 3:30pm 3/4.
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| 57 | 2021-03-08 | appendicitis | APPENDICITIS |
| 57 | 2021-03-14 | difficulty swallowing |
Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives...
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Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives noted on chest, ears itching, no respiratory symptoms or difficulty. Speech clear, no stridor noted. Pt stated does have a significant allergy history and sees an allergist. Medicated with Benadryl 50 mg po and immediately to ED, registered right away, pt then c/o head and back itching, and taken into triage for assessment by triage nurse. Per Hospital Note: Patient initially developed hives and itching with progression in symptoms to include shortness of breath and throat tightening. She reported feeling as though her tongue were swelling and having difficulty speaking and having difficulty swallowing. Concerns of impending loss of airway prompted administration of IV Solu-Medrol, Benadryl and 2 doses of intramuscular epinephrine which were unsuccessful and therefore emergent intubation was performed. Patient apparently has had prior anaphylactoid reactions in the past including bee stings and shellfish.
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| 57 | 2021-03-16 | difficulty swallowing, nausea |
Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told ...
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Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told me that this was acute thyroiditis. My heart rate was very high (122 bpm) when I visited my doctor's office and it was 130 bpm when I was triaged in the Emergency Room. Upon my doctor's advice, I went to the ER in the afternoon of 03/12/2021 where I was further tested. I was given medications to counteract inflammation, nausea and headache. In addition, I was given medication (beta blocker) to lower my heart rate. When my blood pressure was taken after a couple of hours, the readings revealed that my pressure had also started to fall. I spent overnight in the telemetry unit of the ER - I was given 2 liters of IV fluids to stabilize my vitals. The following day (03/13/2021), I met with endocrinologists who told me to what extent my thyroids were affected and what further medications to take. I had told them and other ER doctors as to what precipitated all of this. I was given anti inflammatory medication and a beta blocker that day before I was discharged in the evening. I have no history of thyroid issues or heart issues. I do not suffer from any chronic illness. I was not sick before I took the second dose of the vaccine. I started to feel ill within 5 hours of taking the vaccine shot, and the symptoms worsened over nearly the following two weeks. Now, following medical intervention, I am continuing treatment with various medications. I don't feel well yet, and I understand that the process towards recovery is going to be slow and unpredictable. I wanted to report this, since I feel that scientists and researchers should have this knowledge that thyroiditis can happen as an adverse reaction to the COVID-19 vaccine (Pfizer/BioNTech).
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| 57 | 2021-03-21 | nausea |
Almost immediately felt vertigo like" bed spins". Then tongue began to swell against lower teeth, so...
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Almost immediately felt vertigo like" bed spins". Then tongue began to swell against lower teeth, soon was unable to walk due to vertigo, then chills and extreme nausea like I would vomit but I did not.
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| 57 | 2021-03-30 | vomiting, nausea |
nauseous and vomited; nauseous and vomited; feeling weak; short of breath; I began seizing at the sc...
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nauseous and vomited; nauseous and vomited; feeling weak; short of breath; I began seizing at the scene; tired; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiration date: unknown), via an unspecified route of administration administered in left arm on 05Mar2021 at 00:30 as single dose for COVID-19 immunization. Medical history included hypertension (HTN), and known allergies to erythromycin. Concomitant medication included atenolol and furosemide, both for unspecified indication. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 12Feb2021 at 15:00 in left arm for COVID-19 immunization. Within a few hours after administration of the second vaccine on 05Mar2021, the patient became tired so went to bed early. Upon awakening the following morning (06Mar2021), the patient was nauseous and vomited. She got herself ready for work but noticed she was feeling weak, tired and had short of breath resulting in worsening of symptom. The patient then got in her car hoping to feel better with fresh air. However, her condition significantly worsened resulting in me calling number due to fear that she may expire. Upon arrival of emergency services, her condition significantly worsened, the patient was weak and unable to open car door. She was informed by medical personnel that she began seizing at the scene, in the ambulance and in the ED. Once she was stabilized in the ED, she was admitted for 3 days to continue tests and evaluations. The outcome of the events was recovering. The patient had no COVID-19 prior to vaccination. The patient was tested post vaccination via nasal swab on 06Mar2021 and was negative. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage.; Sender's Comments: Considering the plausible temporal association and lacking any reported alternative explanation, a causative role of BNT162B2 vaccine for all reported SAEs cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-03-31 | abdominal pain upper, nausea, appendicitis |
1ST VACCINE- 1/11/2021 VERY SORE ARM, SAME DAY AS VACCINE . 1ST VACCINE. SECOND VACCINE WAS GIVEN O...
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1ST VACCINE- 1/11/2021 VERY SORE ARM, SAME DAY AS VACCINE . 1ST VACCINE. SECOND VACCINE WAS GIVEN ON 2/01/2021 AND ARM WAS ALSO SORE SAME DAY, DAY TWO, HORRIBLE HEADACHE BEHIND MY RIGHT EYE, NAUSEA, WEAKNESS IN LIMBS. ON 2/25/2021 HAD HORRIBLE STOMACH PAINS, THE NEXT MORING WENT TO ER. HAD ACCUTE APPENDICITIS. HAD APPENDIX REMOVED THE EVENING OF 2/26/2021. I NOW HAVE SOMETHING WRONG WITH MY LUNGS OR HEART. I AM CURRENTLY SEEKING TREATMENT AT CARDIOLOGY.
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| 57 | 2021-04-03 | nausea, vomiting, decreased appetite |
Within a few hours of shot, my headache worsened significantly and got nauseous and lost appetite. F...
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Within a few hours of shot, my headache worsened significantly and got nauseous and lost appetite. Felt terrible and went to be early. Did not sleep well. Woke up Wed 3/31 feeling better but lightheaded/dizzy; dull headache; arm swollen /sore. Thursday 4/1 still lightheaded and more dizzy when I bent down or turned suddenly; arm still sore. Friday 4/2 morning left side of face started to feel numb/tingling , then left fingers/hand, then left toes/foot, then left calf. Checked possible stroke symptoms and no other symptoms so called Dr. NP said to go to ER since it was unilateral numbness/tingling. Admitted to ER about 11:15am and did stroke protocol to rule out stroke...got CT scan, EEG, and MRI with & without dye. All normal. Discharged about 5:45pm. Very lethargic. Sat 4/3 still lightheaded/dizzy and lethargic. Woke up about 3am early Sun (Easter 4/4) in cold sweat and nauseous; vomited; hardly slept. Feel very lethargic today and still lightheaded/dizzy.
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| 57 | 2021-04-10 | difficulty swallowing, abdominal pain |
Severe Abdominal Pain and skin rash in face, neck, chest and left arm for over ten days. Other symp...
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Severe Abdominal Pain and skin rash in face, neck, chest and left arm for over ten days. Other symptoms: lack of taste, muscle pains in lower extremities/back/arm, ringing ear, itching, throat narrowing/shortness of breath, weight loss, extreme fatigue and weakness for several days; brain fog, dizziness, difficulty swallowing/sleeping.
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| 57 | 2021-04-12 | nausea |
Blood pressure was elevated; Started with sweating then light headed nausea and dizzy. 30 minutes a...
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Blood pressure was elevated; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 57-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ep7533) via an unspecified route of administration at arm left on 30Mar2021 10:00 as single dose for COVID-19 immunization. The patient has other medical history and concomitant medications was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Patient had known allergies. The patient experienced started with sweating then lightheaded nausea and dizzy, 30 minutes after injection broke out with hives on neck and chest rash on face and blood pressure was elevated on 30Mar2021 10:15. Therapeutic measures were taken as a result of started with sweating then lightheaded nausea and dizzy 30 minutes after injection broke out with hives on neck and chest rash on face and blood pressure was elevated and was taken to hospital for observation. The outcome of the events was recovering.
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| 57 | 2021-04-24 | abdominal pain |
possible seizure; fainting; chills; headache; joint and long bone pain; dizziness; Right abdominal p...
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possible seizure; fainting; chills; headache; joint and long bone pain; dizziness; Right abdominal pain; temperature spike at 101; unquenchable thirst; sweating; This is a spontaneous report from a contactable consumer (patient) reported for herself that the 57-year-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 08Apr2021 04:00 PM (Lot Number: EW0151) at single dose for covid-19 immunization. Medical history included multiple allergies from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, orthostatic hypotension from an unknown date and unknown if ongoing , traumatic lung injury from an unknown date and unknown if ongoing , metaplasia from an unknown date and unknown if ongoing , hiatus hernia from an unknown date and unknown if ongoing , polyp from an unknown date and unknown if ongoing , diverticulum intestinal from an unknown date and unknown if ongoing , exposure to toxic agent from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole taken for an unspecified indication, start and stop date were not reported; famotidine taken for an unspecified indication, start and stop date were not reported; cyclobenzaprine taken for an unspecified indication, start and stop date were not reported; calcium carbonate;soya isoflavones;vitamin d nos taken for an unspecified indication, start and stop date were not reported; ibuprofen;phenylephrine hydrochloride taken for an unspecified indication, start and stop date were not reported. The patient previously took firs dose of bnt162b2 (BNT162B2) intramuscular, administered in Arm Right on 18Mar2021 04:15 PM(Batch/Lot Number: ER2613) at single dose for covid-19 immunisation. The patient experienced possible seizure on 08Apr2021 20:00 with outcome of recovering , chills on 08Apr2021 with outcome of recovering , headache on 08Apr2021 with outcome of recovering , joint and long bone pain on 08Apr2021 with outcome of recovering , dizziness on 08Apr2021 with outcome of recovering , fainting on 08Apr2021 with outcome of recovering , right abdominal pain on 08Apr2021 with outcome of recovering , temperature spike at 101 on 08Apr2021 with outcome of recovering , unquenchable thirst on 08Apr2021 with outcome of recovering , sweating on 08Apr2021 with outcome of recovering. The patient underwent lab tests and procedures which included body temperature: temperature spike at 101 on 08Apr2021. Therapeutic measures were taken as a result of possible seizure. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical course was reported as follows: 4 hrs post vax: chills, sub normal temperature drop >96 f oral, eat, and airmpit , sub normal low BP, headache, joint and long bone pain, dizziness, 2 episodes of warned fainting (vasovagal); followed by temperature spike at 101 F oral onset @21 hrs. post vax riggors and falls, with warned loss of consciousness & possible seizure, followed by lower right abdominal pain w/rebound tenderness, sweating, unquenchable thirst, until fever broke 30 hrs post onset. At febrile onset 400 mg ibuprofen, followed by 200 mg every 8 hrs until symptom resolution. The adverse event result in any of the following Doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event included Public Health RN telephone consult, ibuprofen see. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products:Yes a long list that does not include PG. Other diagnosed illnesses/medical history/chronic health conditions:IMMUNE SYSTEM: multiple allergies including anaphylaxis; R.A., reactive asthma; CARDIOPULMONARY: reactive asthma, chemical exposure lung injury scaring, COPD, orthostatic hypotension; GI: Barrets esophagial metaplasia, hiatal hernia, colonic polyps adenocarcinoma, diverticula. Follow-up (20APR2021): Follow-up attempts completed. No further information expected.
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| 57 | 2021-04-28 | vomiting |
Diagnosed with cryptogenic posterior cerebellar CVA; severe dizziness; vomiting; arm pain; severe ge...
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Diagnosed with cryptogenic posterior cerebellar CVA; severe dizziness; vomiting; arm pain; severe general back pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 20Jan2021 13:30 (at the age of 57 years old) as single dose for COVID-19 immunisation, at a workplace clinic. Medical history included hypertension (HTN) and depression, both from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. The patient has no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT); and benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ) both taken for an unspecified indication. On 22Jan2021 the patient experienced arm pain and severe general back pain. On 23Jan2021, the patient experienced severe dizziness and vomiting. She went to urgent care and symptoms were treated. The patient was advised to have follow-up with the patient's professional care provider; she had MRI and CT angio of head on an unknown date with unknown results. The patient was diagnosed with cryptogenic posterior cerebellar CVA on 23Jan2021. Due to the events, the patient was recommended to have full diagnostic working including cardiac and neuro workup as treatment. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for three days. The patient underwent lab tests and procedures which included CT angio of head and magnetic resonance imaging (MRI): both with unknown results on an unknown date, and Nasal Swab: negative on 12Apr2021. The patient was recovering from the events.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that vaccine BNT162B2 contributed to the reported events; these are likely intercurrent medical conditions in this patient with underlying hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2020-12-31 | diarrhea | Diarrhea times one on December 30, loose stool times one on December 31, Loose stools January 1. |
| 58 | 2020-12-31 | nausea |
Hands turned red with slight swelling. Face and chest with red blotches. Nausea and pounding heart ...
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Hands turned red with slight swelling. Face and chest with red blotches. Nausea and pounding heart rate. This is the same symptoms I experience if I drink alcohol. I drank water and it got better in an hour. At night, my scalp was itching all nite. My scalp was red on the right side only which was the site of the vaccine. It is now 2 days later; the itching is gone but scalp has red blotches although they have faded at lot.
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| 58 | 2021-01-01 | nausea | Peri-oral tingling, shortness of breath, nausea immediately after injection |
| 58 | 2021-01-03 | nausea |
30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain...
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30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; This is a spontaneous report from a contactable pharmacist. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), intramuscular on 19Dec2020 07:00 at SINGLE DOSE at Left arm for covid-19 immunization. Medical history included breast cancer female and allergies to shell fish and Latex. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 30 minutes after receiving vaccine on 19Dec2020 07:30 am, patient reported 'heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness. Patient was taken to the ED where she received IV Benadryl and was observed for 4 hours. Patient was discharged home and symptoms subsided. The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of the events was recovered in Dec2020.; Sender's Comments: There is a plausible temporal relationship between immunization and onset of allergic reaction in a subject with a positive medical history for allergy to food (shellfish); causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-03 | nausea |
S: Employee received Covid vaccination on 12/28/20. Employee reported noticing "itching all over my ...
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S: Employee received Covid vaccination on 12/28/20. Employee reported noticing "itching all over my body". The following day she experienced nausea and moderate joint pain. She then also experienced redness on forehead, ears and "felt like they were on fire." B: Covid vaccination on 12/28/20. Employee contacted advice nurse and was instructed to report to ACC A: Employee reported to ACC on 12/29/20 and received solumedrol shot R: Reporting for tracking purposes
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| 58 | 2021-01-03 | nausea, diarrhea |
The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the inject...
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The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the injection but at 2AM on the 22nd I woke up from my sleep with chills, and shaking even my teeth were clacking. Took Tylenol and it got better around 30 min later. Felt very fatigued and still nauseated almost threw up. By the end pf the day it resolved itself.
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| 58 | 2021-01-04 | nausea | Dizziness, Light headed, nausea |
| 58 | 2021-01-04 | nausea |
Patient reports chills, joint and muscle aches, extreme fatigue, nausea, insomnia and a general se...
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Patient reports chills, joint and muscle aches, extreme fatigue, nausea, insomnia and a general sense of not feeling well.
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| 58 | 2021-01-04 | nausea |
Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was emp...
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Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was employed as a housekeeper. About one hour after receiving the vaccine she experienced a hot flash, nausea, and feeling like she was going to pass out after she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours, upon arrival to a friends home she complained of feeling hot and having difficulty breathing. She then collapsed, then when medics arrived, she was still breathing slowly then went into cardiac arrest and was unable to be revived.
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| 58 | 2021-01-05 | abdominal discomfort |
Headache, dizziness, disorientation, upset stomach. Headache not resolved with tylenol. Symptoms r...
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Headache, dizziness, disorientation, upset stomach. Headache not resolved with tylenol. Symptoms resolved after 36 hours.
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| 58 | 2021-01-05 | nausea | Swelling deltoid muscle, headache, nausea |
| 58 | 2021-01-05 | nausea | Tachycardia, palpitations, elevated blood pressure, feeling faint, nausea, flushing |
| 58 | 2021-01-06 | diarrhea, nausea | Stiff neck severe headache severe diarrhea and nausea |
| 58 | 2021-01-06 | nausea |
Vaccinated on December 21, 2020. No arm pain, nothing. On December 27th at 4:00 PM sudden onset wors...
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Vaccinated on December 21, 2020. No arm pain, nothing. On December 27th at 4:00 PM sudden onset worst bone pain ever unrelieved with Tylenol, malaise and nausea. December 28th at 1:00 AM awoke in pain and "on fire" I have never been so hot, truly felt like my skin was on fire. Tympanic thermometer 99.0F. Awoke feeling fine and went to work thinking this was SE however symptoms recurred later that morning so I went for testing as I could not differentiate between SE vs illness. Covid negative. If this was a delayed response to vaccine, wanted to report: severe bone pain unrelieved w Tylenol , malaise, nausea, 48 hours. thanks, NP
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| 58 | 2021-01-07 | difficulty swallowing, nausea |
5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizzine...
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5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizziness and a feeling of rapid heart beat. Throat tightness and difficulty swallowing. Flushing sensation and feeling of rapid heart beat resolved within a few minutes, but left with nausea, flushing and difficulty swallowing/throat tightness.
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| 58 | 2021-01-07 | difficulty swallowing |
After 4 minutes of vaccine administration (at 10:00am) patient developed respiratory difficulty and ...
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After 4 minutes of vaccine administration (at 10:00am) patient developed respiratory difficulty and swallowing problems. A Rapid Response code was activated for an Anaphylactic Shock. One dose of Epinephrine 0.3mg IM and two doses of Benadryl 50mg IV were administrated. Vital Signs at 10:02a.m: BP 197/107mmhg, HR 103bpm and O2 Saturation:99%. Vitals Signs at 10:07a.m: BP 211/110mmhg, HR 110bpm and O2 Saturation:98%. At 10:07a.m patient was transfer to the ER by the Rapid Response team.
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| 58 | 2021-01-07 | nausea | Bad headache, dizzy, very tired, nausea, blurred vision. |
| 58 | 2021-01-07 | difficulty swallowing |
Difficulty swallowing. Sensation of lip swelling. Immediate Care response activated. IV Benadryl, So...
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Difficulty swallowing. Sensation of lip swelling. Immediate Care response activated. IV Benadryl, Solumedrol and Pepcid given. Patient taken to Care Center for observation and further care.
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| 58 | 2021-01-07 | nausea |
Joints and muscle aches; Joints and muscle aches; nausea; This is a spontaneous report from a contac...
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Joints and muscle aches; Joints and muscle aches; nausea; This is a spontaneous report from a contactable nurse. A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in arm right on 21Dec2020 10:00 at single dose for covid-19 immunisation. Medical history included allergies to dust, grass, and some weeds. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), estradiol, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), zinc. The patient experienced Joints and muscle aches for 15 days so far, nausea mainly in the mornings for 10 days on 23Dec2020 06:00. Outcome of events was not recovered. Patient has not been diagnosed with COVID-19 prior to vaccination. Patient has not tested for coronavirus disease (COVID-19) since having the vaccine.
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| 58 | 2021-01-07 | vomiting | Severe Headache Rash starting on neck and chest Chills Fever Vomiting |
| 58 | 2021-01-07 | vomiting, abdominal pain upper, nausea, abdominal discomfort |
Severe body ache; it has reached to the back area on both sides; nausea; vomiting; pain below her ri...
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Severe body ache; it has reached to the back area on both sides; nausea; vomiting; pain below her ribs; Stomach upset; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received bnt162b2 (Covid Vaccine) lot no: EK5730, expiry date: 23Dec2020 (as reported), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history included pre-diabetes, hypertension, and flu all from unspecified dates. Concomitant medication included losartan and metoprolol succinate both for hypertension, and atorvastatin (LIPITOR) and acetylsalicylic acid (ASPIRIN) both for preventative for stroke. The patient received the Covid vaccine by Pfizer on 18Dec2020. Then on Saturday (unspecified date), the patient started having symptoms like Covid symptoms. She had severe body ache. She stated it has reached to the back area on both sides and she never had this before. She had nausea and vomiting but she only vomited once. At the time of report, she was still sick and stated that she felt like she was not getting well. Patient's causality for the events was yes and explained because she never had this kind of symptoms before. She always had the flu but the severity of it where it goes out below her ribs, she never had that. It was like her stomach was upset and she had the pain below her ribs. The patient had not recovered from the events.
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| 58 | 2021-01-07 | abdominal pain upper |
Start with the normal sore arm continues on day five, normal headache two days. On the second day, v...
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Start with the normal sore arm continues on day five, normal headache two days. On the second day, very stomach pain so bad could not sleep now for three days.
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| 58 | 2021-01-08 | nausea |
"Pfizer-BioNTech Covid-19 Vaccine EUA. Side Effects: nausea, body aches, chills, headache, fatigue. ...
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"Pfizer-BioNTech Covid-19 Vaccine EUA. Side Effects: nausea, body aches, chills, headache, fatigue. I took Ibuprofen. Symptoms lasted for approximately 36-40 hours.
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| 58 | 2021-01-08 | difficulty swallowing |
Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow....
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Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow. At 5:34 pm when 15 min wait was done told staff what was happening. Was triaged by NP and MD on standby along w/EMT treated w/50 Benadryl/20 Pepcid/125 Solumedrol IVP. Waited in onsite Immediate Care and was given 1L 0.9 NS bolus. Transferred by ambulance to ER at 6:45 pm after experiencing tingling to chest and dizziness. Tingling changed to warmth in route to ER. Observed in ER and discharged home at 9 pm.
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| 58 | 2021-01-08 | vomiting, nausea | Bad headache, dizzy, blurred vision, nausea, very tired. vomiting. |
| 58 | 2021-01-08 | nausea |
Head ache with pressure/pain on top of head on 01/8/2021, woke 01/09/21 with nausea, progressed to h...
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Head ache with pressure/pain on top of head on 01/8/2021, woke 01/09/21 with nausea, progressed to headache and nausea so bad that I couldn't take migraine meds for fear of vomiting. Went to bed with chills. Woke with pain and stiffness in right shoulder joint. Nausea subsided and I took 50 mg immitrex. Could no longer lay down due to head pain, so slept sitting up two hours. Chills continued. Meds finally worked and headache subsided. Chills subsided. Mild nausea persists this evening.
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| 58 | 2021-01-09 | abdominal discomfort, nausea |
Covid19 second vaccination dose at 1030am 1/8/21 into L arm, which became more sore and faster than ...
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Covid19 second vaccination dose at 1030am 1/8/21 into L arm, which became more sore and faster than the first dose. Tired in evening so went to bed early. Around 2100pm chilling/fever began lasting about 5 hours. This was associated with headache, nausea, and arthralgias. No sleep. All day on 1/9/21 very lightheaded, headache, and some nausea. Spent the day lying on the couch. On 1/10/21 while headache still there in am, much improved. Still some uneasiness of stomach. L axillary soreness. Over all feel much better though not fully normal on afternoon of 1/10/21.
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| 58 | 2021-01-10 | nausea |
Friday morning after the vaccination - fever, chills, body aches & nausea. Saturday morning, went to...
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Friday morning after the vaccination - fever, chills, body aches & nausea. Saturday morning, went to the ED with hives that went into her mount & swollen tongue - resolved as of 1/11/2021
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| 58 | 2021-01-10 | nausea | Patient refers developed general malaise, headache, feverish, joint pain, nausea and left arm pain |
| 58 | 2021-01-10 | abdominal pain |
Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Sym...
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Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Symptoms of fatigue began approx. 12 hrs. late, then fever after midnight, chills, body aches, severe headache, abd cramping, and extreme fatigue. Highest fever recorded was 101.8 the next day (Sunday) around 4pm. Didn't take Tylenol or Motrin. As of writing this (Monday 12:07 pm) my fever is gone but headache and extreme fatigue remain. Injection site still sore and today I notice I have a very swollen and painful lymph node left axilla opposite injection site. I had to call in sick today and possible will tomorrow if the extreme fatigue and headache don't go away.
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| 58 | 2021-01-10 | diarrhea, vomiting | dizziness, fatigue, vomiting, diarrhea, headache |
| 58 | 2021-01-10 | nausea |
tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head ...
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tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head on wall, head just hurts; hit head on wall, head just hurts; Chills; she was very cold; could not sleep good; site of vaccine was sore; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK9231) by injection once to left arm, via an unspecified route of administration on 04Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder; patient started it after she had her son, and her son is 18 years old. The patient had her vaccine yesterday (04Jan2021) at 12:30, and at nighttime, around 22:00, she started having chills, she was very cold, so she went to bed, she could not sleep good, she kept waking up, and the site of vaccine was sore, she had muscle pain, joint pain, she didn't have fever, but she got up late today (05Jan2021), around 11:00, and had breakfast and felt nauseated, so she stopped eating, and she went to the bathroom and passed out on the toilet, when she woke up, she had her nightgown inside the toilet, it was all wet, she felt better, so she stood up and then she woke up again, and was inside the tub, her legs were inside the basin, she was lying down with her back inside the tub, she thinks she hit her head on the wall, and it just hurts, it didn't bleed or nothing. The patient stated she had the paper she was given. Again stated she can not even function. Patient still feels Chills a little bit, not as bad as last night. She is awake now, but she feels very very tired, like she has no energy, she is laying down on couch right now. She kept waking up and noticed this morning, she had low back pain, in the muscles, even her fingers are hurting. Regarding hitting her head on the wall, states she has a terrible headache, not a little pain, she thinks it is because she hurt her head. The patient is supposed to get second vaccination on 25Jan2021. The outcome of events Chills, Joint pain and nauseated was recovering; of events site of vaccine was sore and muscle pain was not recovered; of other events was unknown.
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| 58 | 2021-01-11 | nausea, abdominal pain upper, diarrhea |
1//7/2021, day vaccine was administered; within a couple hours I began to experience fatigue, headac...
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1//7/2021, day vaccine was administered; within a couple hours I began to experience fatigue, headache and R arm pain where vaccine was given.1000 mgs. Tylenol was taken, which offered very little relief. 1/8/2021; I awoke with extreme fatigue, unable to sit up, nausea, and diarrhea with stomach pain, headache, which wasn't unrelieved by 1000mgs of Tylenol, unable to raise R arm due to swelling and pain, aching and weakness all over body, joints, and muscles. It also caused a Fibromyalgia flare-up, which I wasn't experiencing prior to vaccine. It was 1/10/2021 before I was starting to feel better.
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| 58 | 2021-01-11 | diarrhea, nausea | 99 fever, dizzy, nauseous, body aches and pain, headaches, diarrhea. Took Ibuprofen |
| 58 | 2021-01-11 | diarrhea, nausea |
Aprox. 12 hours after receiving the vaccine, I developed the following symptoms: headache, low-grad...
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Aprox. 12 hours after receiving the vaccine, I developed the following symptoms: headache, low-grade fever, chills, muscle/body aches, nausea, vertigo, primarily muscle/body aches. My symptoms resolved aprox. 36 hours later. Aprox. 60 hours later, I had a couple of episodes of diarrhea, and was just feeling a little "spacey" and slightly tender behind my eyes.
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| 58 | 2021-01-11 | nausea | Muscle and joint pain. The worst headache I've ever had made me feel nauseous. |
| 58 | 2021-01-11 | nausea |
Night after vaccine fever chills nausea and body aches Next day mild fever and body aches with fatig...
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Night after vaccine fever chills nausea and body aches Next day mild fever and body aches with fatigue Fatigue only two days after vaccine
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| 58 | 2021-01-11 | abdominal pain |
Received vaccine on Monday by Wed afternoon lower abdominal cramping and feeling very unwell. By We...
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Received vaccine on Monday by Wed afternoon lower abdominal cramping and feeling very unwell. By Wed evening had chills and low grade fever 99.4. Called out of work Thursday. Felt terrible. Thursday morning lower abdominal cramping consistent and pain scale between 4-5 with occasional spikes to 8. Also felt terrible. Had body aches, could only lay on couch. Called my gastroenterologist. Office returned call late afternoon and stated probably from vaccine and if it worsens or fever to call primary and to fill out VAERS form. Thursday evening had temp of 100.4 and started with a cough where it felt I couldn't take deep breaths. Only lasted a few hours. Abdominal pain persisted. Friday morning woke up and now have headache, but abdominal pain is now down to a 2 and I feel achy, but feeling a bit better. Had to call out of work still too sick to go in. No cough. No fever. Since I was feeling better my hope was since it was vaccine related that I would wake on Saturday and be totally fine, unfortunately, not the case. Saturday morning abdominal pain same at a 2 and headache was on and off through the day into the night. Still pretty much rested all day into the night. Sunday morning much better. Headache gone and abdominal pain down to a 1 and sometimes just vague. Although I'm feeling better my head feels out of sorts, kind of like my brain can't keep up with my eyes? And new symptoms? right ear crackling and teeth on right side feel sensitive also, pain under left armpit. It's tender and lasts through the day. Monday still feeling a bit lightheaded and fatigued and armpit pain still there but not worse and feel able to go to work to see if I can. Tooth sensitivity also still there but ear pain gone. Called primary doctor she suggests getting Covid test and have appointment for phone conference for Tuesday with doctor, also had Covid test today at work (was Covid tested last Monday also for work and negative) into Monday night head is still feeling "off". Tuesday armpit pain still same and dizzy head feeling same, mild abdominal pain comes and goes - Not bad enough to stop daily activity. Spoke with primary doctor and she said side effects could possibly last this long and let her know when yesterday's Covid test comes in.........
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| 58 | 2021-01-11 | nausea |
Severe Body Aches and Pain, Headache, Chills, Low Grade Fever, Exhausted, Labored Breathing, Nausea-...
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Severe Body Aches and Pain, Headache, Chills, Low Grade Fever, Exhausted, Labored Breathing, Nausea- Covid-19 Symptoms
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| 58 | 2021-01-11 | vomiting |
Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. ...
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Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. A few days later, I felt like my head, on the side of my right ear, had a great deal of pressure in it and it felt "funny " but it did not really hurt. It was uncomfortable and distracting. I waited to see if it would go away. I noticed my hearing was decreased . On 01/06/20 when I woke up, my hearing was completely gone in my right ear. I could hear nothing out of that ear. I had a noise in my head. Just a loud roaring noise. I had severe vertigo and could not walk across the room. I describe this as I felt like I was on a merry-go-round and someone was spinning me really fast. (continue) Additional information for Item 18: Vaccine Adverse Event Reporting System, continued: I also experienced severe vomiting and could not stop. My husband took me to the doctor. Since I could not get in to my regular doctor that day, we went to an ear doctor I had visited a couple of years ago because that was the only person I could find to see me on short notice. I had regular hearing test in the past and my hearing was normal last time he checked it. After doing a hearing test, he verified my Hearing was severely decreased in my right ear. I explained to him, I also feel "foggy" and I have problems concentrating, was having vertigo, and vomiting. I am not sure if that is because of the constant sound in my ear that distracts me but it is a definite problem and interferes with my work. I cannot concentrate. He started me on Steroids (Prednisone) 60 mg a day for 7 days, then 40 mg for 3 days, then 20 mg for three days, Antivert 12.5 mg three times a day as needed, and Zofran for the vomiting if I needed that. I have not experienced anymore vomiting and the Vertigo has been very limited. Mostly when I lay down now instead of when I stand up. My blood pressure has also been slightly elevated, but it could be from the Steroids. I was scheduled to take the 2nd Pfizer Vaccine on 01/09/21. Since I was receiving the high doses of Steroids, I was concerned that the vaccine would not be effective or may interact with the steroids so I went to my family doctor 01/08/21, for a visit. He said he would check and let me know if it was contraindicated for me to take the Vaccine on high doses of steroids. When I did not hear from him, because I had to take the vaccine the next day, I called the Pharmacy and talked to someone there and they told me the agency was still recommending you take the Vaccine even if you are on the steroids. I received the second Pfizer Vaccine on 01/09/21. My hearing is now coming and going but I can hardly hear anything out of that right ear. . There is a constant noise, like a roaring, in my head and I still have problems concentrating. I have had no more vomiting and my vertigo has hot been as severe but I have experienced some at times. I reported to the Pharmacy the day I received my vaccine, 01/09/21, about the things I had experienced this since my first vaccine. They took my information and said they would call me but today is 01/12/21 and I have not heard from them yet so I thought I would go ahead and report this. I am concerned this was an adverse reaction to the vaccine. I return to the doctor 01/20/21 for a repeat hearing exam. The Doctor expressed this condition could be a permanent and disabling issue but currently being treated and will follow up with more testing. I am also concerned about how the second vaccine affected me because I was receiving the high doses of Steroids at the time I received it. I am sending this from a work email so if you reply, please reply to personal email.
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| 58 | 2021-01-11 | decreased appetite, abdominal pain |
Very sore arm hours after vaccine and couldn't move arm during the night- took motrin at 3:30AM with...
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Very sore arm hours after vaccine and couldn't move arm during the night- took motrin at 3:30AM with some effect. Felt OK otherwise until 12 noon on 1/6/21 when I suddenly felt chilled and not well. Temp went up quickly from 99.4 at 12 noon to 102.4 at 5PM. Temp 101.5 at 9PM. Had abdominal cramping, general body aches and muscle pains, H/A and left breast tenderness as if I was going to get my period (which I haven't had for 8 years). On 1/7/21 at 7AM temp- 99.7 and 98.8 at 11AM, but still felt tired, H/A, malaise, no appetite. Back to normal good health on 1/8/21 AM. Left arm was sore for 4 days.
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| 58 | 2021-01-11 | nausea | dizziness, nausea taking meclizine . Still experiencing dizziness as of 1/12/2021. |
| 58 | 2021-01-11 | nausea |
immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really swe...
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immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really sweaty, so much so, that she had sweat under her eyes; thyroid problems; feels shaky inside; Numbness facial; Exhaustion; Foggy feeling in head/feeling rundown; felt exasperated; sweating like crazy and then gets chills; felt yucky/she didn't feel good at all; Joint pain; Nausea; Chills; after receiving the COVID-19 Vaccine on (Dated), she had left upper shoulder pain.; She clarified she had some injection site pain; and the injection site was a little itchy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration on 02Jan2021 14:30 at single dose in the left upper arm for COVID-19 immunization. Medical history included Pernicious anaemia from 2006 and ongoing, Hashimoto's disease ongoing, stated she was diagnosed with Hashimoto's disease in either 1994 or 1995. Psoriatic arthritis from Nov2020 and ongoing. Potassium low ongoing, reported she has had low potassium off and on for years. She said she can't remember when she didn't have low potassium. She said she normally finds out her potassium is low when she has blood work done. She stated she has had low potassium most of her adult life. IgA deficiency from Feb2019 and ongoing, Psoriasis ongoing, paralysis in her left trapezius muscle. Concomitant medication included B-12 for pernicious anemia. She said she had the typical reactions that one might get with a vaccine. She clarified she had some injection site pain and the injection site was a little itchy on 02Jan2021. She stated on the second day (03Jan2021) she had joint pain, felt yucky, had nausea, and chills. She said the next day (04Jan2021) she felt a little better, but still had chills. She said yesterday (05Jan2021) she thought she was feeling better, but by yesterday, clarified as late afternoon and evening, she crashed. She said she has a lot of autoimmune issues and immune deficiencies, saying she has pernicious anemia and Hashimoto's disease. She said yesterday evening she experienced extreme body temperature issues. She said she was really sweaty, so much so, that she had sweat under her eyes. She said she would get really hot and had chills. She said she was feeling really bad and was feeling shaky inside. She said she thought it was important that she report what she was experiencing to Pfizer. She stated she has psoriatic arthritis, too. Reported after receiving the COVID-19 Vaccine on 02Jan2021, she had left upper shoulder pain. She clarified that she had a previous history of paralysis in her left trapezius muscle and had surgery in 1998 on her left shoulder. She said she had a weird feeling that went around where her scar was from the surgery on the back of her left shoulder. She said maybe the left shoulder pain had to do with how she held her left shoulder. She said on Monday, 04Jan2021, she had a little bit of pain in her left shoulder and by yesterday night, 05Jan2021, there was not much pain at all. Clarified her joint pain was in her ankles, wrists, hips, neck, back, and knees. She said the joint pain felt like "flu" joint pain. She stated she normally has joint pain with the other issues she has, but this joint pain felt different. She said the joint pain she experienced after taking the COVID-19 Vaccine was all over her body. She said yesterday (05Jan2021) her joint pain felt so much better, but later in the afternoon she didn't feel right. She said she has pernicious anemia, and thought maybe she needs her B-12 shot. She said yesterday (05Jan2021) she experienced a lot more symptoms. She said she had numbness in her face, felt extremely exhausted, had a foggy feeling, and felt exasperated. She said the symptoms didn't start until late in the afternoon into the evening of 05Jan2021. She said she did not feel well and went to bed at 8:45PM, which is early for her. She said she did give herself a B-12 1mcg/ml shot intramuscularly yesterday. She provided the B-12 1mcg/ml NDC Number: 7006900510, Lot Number: C0495, and Expiration Date: Aug2022. She said the name (company name) was listed on the B-12 1mcg/ml packaging. She said she gives herself a B-12 shot every 10 days. She said she still has some joint pain, but the joint pain is not like it was on 03Jan2021. She said she still has a tiny bit of heaviness in her joints with a constant throbbing pain, which is a different joint pain from her normal. Reported last night (05Jan2021) she didn't feel good at all. She said she felt horrible, and had to go to bed. She said she felt shaky inside all night, and still feels that way now. She said she was sweating like crazy, and then would get chills. She clarified she is used to being hot and cold in her normal life because of her thyroid problems, but stated what she experienced last night was beyond that. She said her hot and cold issue was bumped up several levels last night. She said she was chilled or sweating all the time last night, but did not have a temperature. She clarified her normal body temperature is 96.7, and when she checked her temperature at one point, her temperature was 98 degrees. Reported the hot and cold with sweating and chills, and nausea come and go. She said if she has nausea, it is a mild feeling of nausea. Clarified if Sunday, 03Jan2021. was a work day, she would have called out sick. She said Monday (04Jan2021) and Tuesday (05Jan2021) she did go to work. Reported she has low potassium and made herself an electrolyte cocktail. Reported if her system feels off, she said her electrolytes maybe off. She said her heart felt like it may be shaky, so she ate a banana to get potassium in her system. She said she does her little routine before she would call her doctor to get blood work done. She said she had her blood work done not too long ago. She said she wasn't feeling this way before she had the COVID-19 Vaccine, and is feeling rundown now. She said she was feeling good before she had the COVID-19 Vaccine. She said she feels like something is going on with her body now. Reported her last blood work was done on 04Dec2020 and everything was kind of normal. She clarified her thyroid was a little off, and her doctor adjusted her medication. She said her potassium was a little down. Reported she was told when she got the COVID-19 Vaccine shot she has to be a little more careful, and she might not be as protected as some people. She said she was told there have not been enough studies on the COVID-19 Vaccine. She clarified she was told that information by a person at the site where she received the COVID-19 Vaccination, saying the person was helping her with the COVID-19 Vaccination authorization form. Reported she thought she was doing OK after she received the COVID-19 Vaccine, until after last night and yesterday afternoon. She said if she continues feeling the way she is, she will see her doctor. She said her system seems off. She said she normally tries everything she knows first, like drinking a lot of water, and drinking electrolytes, and will take potassium to see if that is the issue. She said those are her own things that she does before she calls her doctor. Clarified sometimes she has numbness in her face due to not having her B-12. She said she still has a little numbness in face. She said on 05Jan2021, the numbness went across her face from the bridge of her nose down through to her mouth. She said the numbness was nothing like paralysis in her face, but her face was really hot at the same time she had the numbness. Reported she took Tylenol (clarified as (company) brand Tylenol, stating she doesn't have the UPC, Lot and Expiration Date). She said the Tylenol wasn't kicking in, so she took Ibuprofen (clarified as (company)brand Ibuprofen, and she doesn't have the Ibuprofen NDC, Lot and Expiration date). She said she took her normal medications. Outcome of events "She clarified she had some injection site pain" "and the injection site was a little itchy" and Shoulder pain were recovered on an unspecified date, "Chills" and "feels shaky inside" were not recovered, "Joint pain" "Nausea" "Numbness facial" were recovering, while outcome of other events was unknown.
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| 58 | 2021-01-12 | nausea |
7 hours after 2nd inj developed fever 101, headache, exhaustion and severe body aches nausea. lasted...
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7 hours after 2nd inj developed fever 101, headache, exhaustion and severe body aches nausea. lasted 24hour, better now
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| 58 | 2021-01-12 | abdominal discomfort, vomiting, nausea |
After about 10 min from administration, pt c/o dizziness, and headache with sharp pain to L side of ...
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After about 10 min from administration, pt c/o dizziness, and headache with sharp pain to L side of head. GIven apple juice. Transferred to wheel chair. B/P: 162/105. Pulse ox 98, heart rate 93. . Transferred to bed in holding room. Remained dizzy with headache, B/P 155/93. Pulse ox 100%, heart rate 90. Complained of difficult to breathe laying flat. Elevated HOB to 30. Patient states feeling lik eshe could breathe better. Complains of nausea, but taking sips of water.. Pt has history of hypertension with self-reported baseline of 135/90's. Given water, allowed to rest. At 1421, BP 141/93 but remains dizzy, despite dark environment. At 1427. patient verbalizes still dizzy. Verbalizing stomach upset, nausea. AT 1437, Pt Vomit. B/P 158/105. Report given to ER nurse. Pt transferred to ER at 1450.
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| 58 | 2021-01-12 | abdominal pain upper, diarrhea | I was having diarrhea and stomach cramps which last the whole day and night. |
| 58 | 2021-01-12 | abdominal pain upper |
Received vaccine at 4:40pm. Approximately 8pm I started with stomach cramps and had those for a few ...
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Received vaccine at 4:40pm. Approximately 8pm I started with stomach cramps and had those for a few hours. During the night I tossed and turned and my hips were very achy. I woke with a fever that went as high as 101 and was very shivery all day. Fever reduced with Ibuprofen around 6 in the evening. Seemed to feel better. Very restless though the night and hips achy and awoke with a fever. Took Iuprofen. Fever reduced and slight headache. Tired but much better today.
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| 58 | 2021-01-12 | vomiting |
Systemic: Chills-Mild, Systemic: Vomiting-Mild, Systemic: hypotensive, heat flashes, dizziness, (pat...
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Systemic: Chills-Mild, Systemic: Vomiting-Mild, Systemic: hypotensive, heat flashes, dizziness, (patient recovered before leaving for ER, only sent due to past cardiovascular events)
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| 58 | 2021-01-12 | nausea | spiked fever of 101.5 severe uncontrollable chills full body aches nausea |
| 58 | 2021-01-13 | nausea |
"I received the second does of the Pfizer vaccine on Jan 8th with no adverse reaction that day. When...
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"I received the second does of the Pfizer vaccine on Jan 8th with no adverse reaction that day. When I awoke on Saturday the 9th my arm was very sore at injection site but later went away. I had a dull headache, nausea, I was yawning all day, muscle fatigue, esp my quads, lightheaded enough to lay on the floor a few times during day. These symptoms did not stop me from painting, but I did feel horrible but I pushed through it. Sunday still nauseous, just feeling not my self..... I awoke on Monday morning and I was 100% fine!"
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| 58 | 2021-01-13 | diarrhea | Body Aches, Headache, Sore Arm, Diarrhea |
| 58 | 2021-01-13 | nausea |
Within minutes of receiving first COVID vaccine, patient experienced a feeling of warmth, lighthead...
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Within minutes of receiving first COVID vaccine, patient experienced a feeling of warmth, lightheadedness and elevated blood pressure of 210/110. BP down to 170/100 at the time of leaving appointment (20 minutes after shot). The next day she felt nausea, Ha, body aches and burning sensation down the arm of the injection.
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| 58 | 2021-01-13 | abdominal pain upper |
sick to stomach and headache within 15 minutes, then about 1/2 hour later broke out in hives and had...
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sick to stomach and headache within 15 minutes, then about 1/2 hour later broke out in hives and had to go to emergency room and get some Benadryl and stay and be monitored for hour.
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| 58 | 2021-01-14 | vomiting |
1/12-N/V was vomiting every 15 mins. Started about 1300 after getting the vax. by 1430 starting vomi...
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1/12-N/V was vomiting every 15 mins. Started about 1300 after getting the vax. by 1430 starting vomiting uncontrollably. HA. Sx worsened through the night. Felt extremely dehydrated and dizzy. Went to ER on 1/13 in the AM, got IVF, Zofran IV, Phenergan IV, Benadryl, Toradol, Dilaudid. D/C'd home 1/13 Thurs-no nausea, felt achey 1/14 Friday (today)-sore. Feels ok, working from hom.e
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| 58 | 2021-01-14 | nausea |
After 15 minutes felt dizzy when got up to walk. Sat back down for about half hour. Still felt dizz...
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After 15 minutes felt dizzy when got up to walk. Sat back down for about half hour. Still felt dizzy, but went home. Began to feel nauseated and headache which continued from Saturday through currently. On Wednesday 4:00 a.m woke up to feeling of itchyness in chest. It spread to stomach, then legs, arms, face, back head in about an hour and a half. Took a shower and then felt burning. called doctor next morning at 10:30 and told to start benadryl and allegra. Stared about 1:00 pm. very drowsy and increased headache and nausau. Could still feel burning. Continued with about 3 does. Work up 12:38 on Thursday morning with increased burning and itching and benadryl was last taken 7 and half hours before. Did not take benadryl on Thursday due to drowsyness. Did not work Wednesday or Thursday. Friday early morning hours, woke up several times with itchiness and burning. This is all over my body. No rash at any time. Continued headache and nausea.
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| 58 | 2021-01-14 | nausea |
Left arm pain from shoulder to elbow; extreme fatigue; headache; joint pain; chills; low grade fever...
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Left arm pain from shoulder to elbow; extreme fatigue; headache; joint pain; chills; low grade fever; nausea; This is a spontaneous report from a contactable Other HCP reported for herself (patient). This 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via an unspecified route of administration from 07Jan2021 at 15:45 at single dose on left arm for COVID-19 immunisation. Medical history included COVID-19 and was sick for 17 days, no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified concomitant medications. The patient experienced left arm pain from shoulder to elbow, extreme fatigue, headache, joint pain, chills, low grade fever, nausea on 07Jan2021 at 21:00. Symptoms started five hours after injection and did not abate until about 64 hours after vaccination. No treatment was received for the events and all considered as non-serious. The outcome of the events was recovered in Jan2021.
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| 58 | 2021-01-14 | nausea |
reported symptoms of one wave of nausea (which quickly resolved) and a warm pulsing sensation to her...
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reported symptoms of one wave of nausea (which quickly resolved) and a warm pulsing sensation to her left posterior hand from wrist distally to index finger.
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| 58 | 2021-01-14 | nausea, vomiting | vomiting, headache, nausea, joint pain. called in sick to work. |
| 58 | 2021-01-15 | nausea, diarrhea | Fever chills aching and nausea and diarrhea and fever blister |
| 58 | 2021-01-16 | nausea |
1/15/21 at 0900 injection. some mild headache between then and 2300 when I had chills, headache, bod...
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1/15/21 at 0900 injection. some mild headache between then and 2300 when I had chills, headache, body aches, Nausea, T 100.2 F. 1/16/21 0200 took Tylenol 500mg nausea, chills HA T 100.8 at 0410 symptoms continue and I i still had insomnia (that is not uncommon for me) symptoms were a bit milder. 0420 took 500mg Tylenol, 1030 500 mg tylenol HA nausea dizzy T 100.8F. 2345 bad again. took 1000 mg Tylenol and a 3mg tab of Lunesta. body aches HA nausea chill dizzy T 100.7. Overnight I had a bout of terrible night sweat and the bed and pillow and night clothes were soaked (not menapausal related) 1/17/21 0830 T 97.8 feel a bit better. as the day goes on I notice when I move around, especially quickly I have a horrible pain in my head and dizziness. at 1700 T99.9 nausea, dizzy HA.
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| 58 | 2021-01-17 | nausea |
Patient demonstrated signs of dizziness, nausea and feeling chills roughly five minutes after admini...
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Patient demonstrated signs of dizziness, nausea and feeling chills roughly five minutes after administration of vaccine. Patient became dizzy enough to lose balance and fall after attempting to stand up. At this point, EMT services were called in as a precaution. As EMT services arrived, patient felt potential difficulty breathing. After discussion with EMT team, epinephrine was not administered immediately; patient received an injection of Benadryl and then was transported to hospital. From second hand information obtained , the patient has been stabilized and is feeling better following their trip out to the hospital. No official paperwork or direct contact with the patient has been made at this time.
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| 58 | 2021-01-17 | difficulty swallowing |
Patient developed tongue tingling 30 minutes after receiving first dose of Pfizer covid vaccine. Pat...
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Patient developed tongue tingling 30 minutes after receiving first dose of Pfizer covid vaccine. Patient also reports that she experienced tongue swelling, lip swelling, difficulty swallowing and rash on her back that developed 1 hour after vaccine. Patient did not seek immediate medical treatment and will receive treatment at Occupational Health.
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| 58 | 2021-01-17 | nausea |
Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour afte...
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Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour after vaccine, felt fatigued the day of the vaccine for about an hour after, On 1/14 at 0530 woke up with a horrible right calf cramp was relieved by massage. Sat at side of bed began feeling extremely nauseated, diaphoretic then syncopal episode that lasted approximately 5 seconds.
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| 58 | 2021-01-18 | abdominal pain, diarrhea |
Fever 101.5, chills, headache, muscle aches and diarrhea-1/13/21. Fever 100.7 headache, muscle aches...
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Fever 101.5, chills, headache, muscle aches and diarrhea-1/13/21. Fever 100.7 headache, muscle aches 1/14/21. Abd pain 1/16, 1/17 ER admission- abdominal pain 1/18. Discharge home. Rash and abd pain 1/19
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| 58 | 2021-01-18 | abdominal pain upper, nausea, vomiting |
I started feeling tired the day after my injections (day 2) and didn't think much of it until i got ...
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I started feeling tired the day after my injections (day 2) and didn't think much of it until i got home around 6:00 pm and i was exhausted. I couldn't even open my eyes without putting effort into it. By the next morning (day 3) i was extremely tired and it hurt in my leg muscles, butt muscles, arms and stomach. I woke up at 2:30 PM and threw up. The next day (day 4) i had diarrhea and was still exhausted and just felt lousy. Today is day 7 and i finally came back to work. I still have a slight headache and nausea and stomach cramping on/off.
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| 58 | 2021-01-18 | nausea | Light headedness for 4 hours Dizziness for 30 minutes Nausea for 3.5 hours |
| 58 | 2021-01-18 | nausea | Nauseous, extremely sore and aching muscles and body, migraine |
| 58 | 2021-01-18 | nausea |
Severe Head/Neck ache Body Aches Fever (101 - 102) Hard Chills Nausea All Fingers were cold to the ...
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Severe Head/Neck ache Body Aches Fever (101 - 102) Hard Chills Nausea All Fingers were cold to the touch and severely aching (felt as though they were frost bitten) Fatigue
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| 58 | 2021-01-18 | diarrhea, nausea |
Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath,...
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Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath, itching, severe chills alternating with fever, chest pain, facial nerve numbness, blurry vision, sore throat, nausea, diarrhea. Treatment was a Medrol Dose pack for 6 days. Outcome was severe symptoms decreased after 4 hours of taking first dose (6 tabs) of prednisone. As the prednisone dose decreases each day there is increased muscle pain and shortness of breath/lung tightness with activity, and severe fatigue
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| 58 | 2021-01-19 | vomiting |
I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet w...
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I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive.; I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day; I woke up at midnight and felt extreme malaise; I was covered in sweat; vomited; I checked my temp and it was 99.7°F; sore; I think I had either a seizure or a vasovagal response.; This is a spontaneous report from a contactable nurse (patient). This 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular at single dose in the left arm on 09Jan2021 06:00 for Covid-19 immunisation. Medical history included atrial fibrillation on unknown date (1 episode), allergic to Keflex. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular in the left arm on 22Dec2020 for Covid-19 immunisation. On 10Jan2021 01:00 AM, the patient experienced: I began to pass out and yelled for my husband, he said when he came in i was sitting on the toilet with my head back, eyes rolling back not responsive (loss of consciousness) (medically significant), I had my 2nd vaccine at work early sat the 9th and felt increasingly worse all day (feeling abnormal), Iwoke up at midnight and felt extreme malaise (malaise), I was covered in sweat (hyperhidrosis), vomited (vomiting), I checked my temp and it was 99.7°F (pyrexia), sore (pain), I think I had either a seizure or a vasovagal response (seizure). No treatment required. The outcome of the events was recovered. The events were described as follows: I am healthy RN with no active medical problems. I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day, I expected this so was not alarmed and went to bed around 10pm. I woke up at midnight and felt extreme malaise and went to the bathroom in case I might vomit, etc. and I tried to have a BM. I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive. He yelled at me for about 10 seconds and I came to, I was covered in sweat. I asked him to walk me back to the bedroom where I again passed out, fell to the floor and hit the bed, then was unresponsive again for about 10 seconds then came to again and vomited. After this I felt completely relieved of my malaise. I checked my temp and it was 99.7°F. After this I was sore but otherwise completely okay, the next day I had a temp of 99.5°F. Today I am back to normal. I think I had either a seizure or a vasovagal response. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event "began to pass out" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-19 | diarrhea, vomiting |
On Tues, 1/12 I started feeling like I was getting a cold because I got the chills when I got home,...
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On Tues, 1/12 I started feeling like I was getting a cold because I got the chills when I got home, but not the flu because I had my flu shot in Oct.2020 Wednesday 1/13 I left work because I started with vomiting, diarhhea , a light headache and my arm was real sore. That continued on through that night and into the next morning. So I had to call in at work that morning 1/14. I finally started feeling better by friday night, 1/15. The headache was gone and the chills were only slight and I could finally keep some toast down. Before that I could only slightly keep liquids down.
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| 58 | 2021-01-19 | nausea |
Reported nausea, but it went away. Feels tired. After conversation, possibly just anxiety. COVID ...
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Reported nausea, but it went away. Feels tired. After conversation, possibly just anxiety. COVID call center advised return to work.
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| 58 | 2021-01-19 | nausea | Systemic: Rash (other than injection site)-Mild, Systemic: Nausea-Severe, Systemic: Vertigo-Severe |
| 58 | 2021-01-20 | diarrhea |
10 days after injection, woke up at 4am on 1/20/21 with intense lower abdominal pain near pubic bone...
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10 days after injection, woke up at 4am on 1/20/21 with intense lower abdominal pain near pubic bone, tenesmus,diarrhea, stools- white mucous with blood, headache, chills, fatigue. Temperature 99.5
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| 58 | 2021-01-20 | nausea |
1525 - states she is experiencing vertigo. Transported via w/c to private observation area. EMT on s...
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1525 - states she is experiencing vertigo. Transported via w/c to private observation area. EMT on site in attendance. Patient able to transfer from chair to w/c without difficulty. States, "my head is swimming and I have nausea" States she has hx of vertigo but this is different as per statement above. HR 86; BP 148/68; O2 97% on room air. States she drove self, has service dog with her. States she ate a late breakfast. States she had a COVID test this morning at for pre op biopsy to be done this Friday 1/22/2021. Denies exposure to COVID. 3:50, examined per Dr. Gave patient gatorade and granola bar. Also drank about 2 ounces of water and tolerated with n/v. Ate about 1/4 granola bar. O2 98%; HR 88 4:02 PERRL - NO nystagmus noted. Tol. 10oz gatorade without n/v. States she has too much nausea to eat anything. Offered ambulance transport for further evaluation. Patient unsure what to do. 4:05 - Had patient stand up next to w/c. Mobility steady. Patient looking down at her dog without any swaying noted. Patient sat back down. 4:08 Patient ambulated independently to end of hallway. Gait steady, no assistance required. Reached outside doors. No symptoms of vertigo. No n/v. States she will go home and rest. Advised to seek medical attention if vertigo returns. Declined transport to hospital. Left with her service dog to personal vehicle
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| 58 | 2021-01-20 | nausea, diarrhea, abdominal pain upper |
Da of Vaccine-1/11/21-at about 7:00 pm in the evening employee started having nausea, left arm (vacc...
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Da of Vaccine-1/11/21-at about 7:00 pm in the evening employee started having nausea, left arm (vaccine arm) pain, all left side pain and numbness down to left foot, fever 99-100, diarrhea, joint soreness, stomach cramps. Day 2-1/12/21-headache, diarrhea, left side all felt heavy, left arm remained sore and limited ROM in left arm. Day 3-1/13/21-Mild diarrhea only and on Day 4 1/14/21-nothing, all symptoms gone.
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| 58 | 2021-01-20 | nausea, diarrhea, abdominal pain upper |
Day 1-1/11/21-Vaccine provided, employee started having nausea at about 7:00 pm with, left arm pain ...
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Day 1-1/11/21-Vaccine provided, employee started having nausea at about 7:00 pm with, left arm pain and left side body pain and numbness down to foot, fever 99-100, diarrhea, joint soreness and stomach cramping. Day 2-1/12/21-diarrhea, headache, heavy feeling on left side of body, left arm soreness with limited ROM in left arm. Day 3-1/13/21-mild diarrhea only, Day 4-1/14/21-no symptoms, nothing.
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| 58 | 2021-01-20 | diarrhea, abdominal pain upper |
Headache; extreme fatigue; all over body aches; stomach pain; diarrhea; unable to move R arm due pai...
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Headache; extreme fatigue; all over body aches; stomach pain; diarrhea; unable to move R arm due pain and swelling; unable to move R arm due pain and swelling; unable to move R arm due pain and swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK-9231 and expiration date not reported), intramuscular on the right arm, on 07Jan2021 at 07:15 at a single dose for Covid-19 immunization. Medical history included fibromyalgia and chronic fatigue syndrome. The patient has no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. Concomitant medications included vitamin D, niacin, hydrocodone bitartrate, paracetamol (NORCO), and paracetamol (TYLENOL). On 07Jan2021 at 11:00AM, the patient experienced headache, extreme fatigue, all over body aches, stomach pain, diarrhea, and unable to move R arm due pain and swelling. The patient did not receive treatment for the adverse events. The patient underwent Covid test post vaccination (Antigen and PCR) and result was SARS-CoV-2 test negative on 11Jan2021. The outcome of the events was recovered/resolved in Jan2021. The reporter assessed the events as non-serious.
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| 58 | 2021-01-20 | nausea, decreased appetite | Nausea, headache, chills, sweats, swelling to the tongue, SOB, loss of appetite, shakiness, |
| 58 | 2021-01-20 | vomiting, nausea |
headache, dizziness, nausea, vomiting patient left the site at 15 minutes post-vaccination and retu...
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headache, dizziness, nausea, vomiting patient left the site at 15 minutes post-vaccination and returned shortly thereafter reporting symptoms as noted.
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| 58 | 2021-01-20 | nausea | nausea, headache, achiness through the night, dissipating by noon the following day |
| 58 | 2021-01-21 | nausea | Fever, Nausea, Headache |
| 58 | 2021-01-21 | vomiting, nausea |
Lightheadedness, dizziness, blurred vision, elevated BP with normal respiration and pulse, nausea, v...
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Lightheadedness, dizziness, blurred vision, elevated BP with normal respiration and pulse, nausea, vomiting, chills, drop in body temp to 96F. Onset 10 mins post injection, increasing over the subsequent hour, subsiding x 1 hr then peaking 5 hrs later, resolved after 12 hours.
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| 58 | 2021-01-21 | diarrhea |
Morning after vaccination noticed rash of small red areas and blisters on bilateral upper arms. Thur...
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Morning after vaccination noticed rash of small red areas and blisters on bilateral upper arms. Thursday rash had spread to legs, back, and neck. Pruritic rash that is tender to touch. Diarrhea began Thursday, 4-5 episodes in 1 day. Fatigue also began Thursday. Has tried 25mg benadryl on Wednesday and Thursday with no relief. No fever.
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| 58 | 2021-01-22 | nausea | Nausea, aches and pains, fever over 100, dizziness and chills. |
| 58 | 2021-01-23 | vomiting, nausea |
Ten hours post vaccine Fever as high as 102.6, rigors, headache, body aches, nausea and vomiting wh...
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Ten hours post vaccine Fever as high as 102.6, rigors, headache, body aches, nausea and vomiting which lasted 36 hours. Completely resolved at 48 hours.
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| 58 | 2021-01-24 | diarrhea, nausea |
Dizziness; Diarrhea; She was not feeling well; Had a body temperature of 99 degrees Fahrenheit; Had ...
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Dizziness; Diarrhea; She was not feeling well; Had a body temperature of 99 degrees Fahrenheit; Had gastrointestinal issues; Nausea; Had allover muscle aches; This is a spontaneous report from a contactable consumer reported for herself. A 58-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 10Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included ongoing hypothyroidism for the last 15 years. The patient's concomitant medications included ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN) and cetirizine hydrochloride (ZYRTEC ALLERGY). The patient experienced dizziness that was bad the following morning, 11Jan2021. She said the dizziness was so bad, she had to have her husband take her to a dentist appointment because she did not feel safe driving. She said she was not feeling well, and was surprised her dentist even saw her that day. She said the dizziness resolved later that day by 7:00PM. Feeling Unwell Treatment: Reported she took 3 Equate brand Ibuprofen 200mg tablets (600mg dose) twice on 11Jan2021. Reported she didn't have a fever, but had a body temperature of 99 degrees Fahrenheit, saying her body temperature usually doesn't run that high. Reported she had gastrointestinal issues. She said she woke up yesterday, 11Jan2021, and was feeling bad. She said her symptoms hit all at once. She clarified she had diarrhea and nausea. She said the diarrhea remains as of this morning, 12Jan2021. She said as soon as she eats, the diarrhea is there. She said she is drinking PowerAde to keep her electrolytes going, but the diarrhea is wiping her out. She said she felt like she was hit by a Mack truck, or has a bad hangover. She said the nausea is gone, clarifying the nausea resolved this morning, 12Jan2021, upon waking up. Diarrhea Treatment: Reported she tried a generic Imodium, saying she took 2 generic Imodium tablets, and the generic Imodium didn't do anything. Reported she had allover muscle aches that started on 11Jan2021. She said her muscle aches improved, and she only has muscle aches remaining in her intestinal tract. Reported she told her doctor she felt horrible and was taking Ibuprofen for muscle pains and a slight fever. Outcome of event dizziness, Nausea was recovered, of Diarrhea was not recovered, of muscle aches was recovering, of others was unknown.
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| 58 | 2021-01-24 | nausea, diarrhea | Fatigue, nausea, diarrhea, chest pain |
| 58 | 2021-01-24 | abdominal pain upper | Headache, cough ,wheezing, stomach pain |
| 58 | 2021-01-24 | abdominal pain, nausea |
Next morning 1/24/21 headache, malaise, nausea, some abdominal cramps, muscle pain, low grade fever ...
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Next morning 1/24/21 headache, malaise, nausea, some abdominal cramps, muscle pain, low grade fever 99.4, lasted all day and evening, symptoms less and resolving the next day 1/25/2021
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| 58 | 2021-01-24 | nausea, vomiting |
Slight swollen lips, hive like rash on legs, Nausea and vomiting: all went away with in 24 hours sev...
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Slight swollen lips, hive like rash on legs, Nausea and vomiting: all went away with in 24 hours severe vertigo with this for 2 days, vertigo is still happening on 3rd day but has lessened did not seek medical attention: took benadryl 1st day only and it took care of the symptoms except vertigo Started Meclizine 25 mg over the counter on day2 and it makes vertigo tolerable but still persitant at this point
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| 58 | 2021-01-25 | abdominal pain upper |
muscle aches; significant stomach pain; felt numbness and tingling around the mouth; tingling around...
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muscle aches; significant stomach pain; felt numbness and tingling around the mouth; tingling around the mouth; This is a spontaneous report from a contactable other HCP(Patient). A 58-year-old female patient received second dose BNT162B2(lot number EK9231), via an unspecified route of administration at Arm Left on 12Jan2021 11:45 at 58 years old at single dose for COVID-19 immunization. The patient medical history was Graves' disease and COVID-19. Concomitant medication included ibuprofen(MOTRIN) and diclofenac sodium. The patient previously took Percocet and Darvocet, both experienced Drug Allergy. The Historical Vaccine was first dose BNT162B2(lot number EJ1685) received on 22Dec202011:45 at 58 years old at Left arm and experienced body ache, muscle aches, feeling like coming down with the flu. While receiving the product the patient felt numbness and tingling around the mouth that went away in about 30 minutes on 12Jan2021 then the next day 13Jan2021 02:30 muscle aches and rather significant stomach pain. There was no treatment received for all the events. There was no covid tested post vaccination. There was no other vaccine in four weeks. The outcome of events numbness and tingling around the mouth was recovered on 12Jan2021 , the events muscle aches and stomach pain was recovering.
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| 58 | 2021-01-26 | nausea |
15 minutes after her second dose of the injection, patient reported ringing in both ears. Very loud...
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15 minutes after her second dose of the injection, patient reported ringing in both ears. Very loud. She also reports her parkinson symptoms are increasing. Shaking of arms and legs were observed. Patient also reported nausea.
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| 58 | 2021-01-26 | nausea, vomiting |
Headache; congestion (sinus); severe vertigo; Vomiting; Nausea; This is a spontaneous report from a ...
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Headache; congestion (sinus); severe vertigo; Vomiting; Nausea; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on the right arm for COVID-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. On 06Jan2021, the patient experienced severe vertigo. Patient also experienced headache, congestion (sinus) on an unspecified date. On 05Jan2021, patient experienced vomiting and nausea. Patient stated that she went to her primary care and was given patch for nausea and was given a different sinus brand to clear up the congestion. Patient stated that with all these, she is pretty sure that she does not want the second dose. Patient stated that she has symptoms of the vaccine than rather COVID and wanted to know what were the recommendations. The outcome of the event congestion (sinus) was not recovered, vomiting was recovered 05Jan2021, while the other events was recovering.
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| 58 | 2021-01-26 | nausea, vomiting, diarrhea | Vomitibg, diarrhea, nausea dehydration |
| 58 | 2021-01-26 | nausea |
extremely sore at the injection site. I had overnight chills starting at 9pm on 1/21/2002 through ...
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extremely sore at the injection site. I had overnight chills starting at 9pm on 1/21/2002 through morning. I took my temp on 1/21 at 9am and it was normal. (98.4) Body aches, and nausea most of the day on 1/21/2021. treatment: Ibuprofen 600mg BID X 2 days.
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| 58 | 2021-01-27 | diarrhea |
1st dose just sore arm mild headaches, body aches lasted 2 - 3 days. 2nd dose had not in arm, sore ...
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1st dose just sore arm mild headaches, body aches lasted 2 - 3 days. 2nd dose had not in arm, sore arm hot for about a week, mild headaches, body aches, diarrhea, chills out of breathe, fatigue - but no temp. This has being going on and off for last 2 weeks. Just had diarrhea on 1/25/21 again with chills, fatigue, little out of breathe, mild headache. 1/28/21 went back to work with chills, mild headache, out of breathe but no temp. 97.1 this morning.
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| 58 | 2021-01-27 | diarrhea |
Headaches daily on an off, specifically left eye, for approximately 10 days starting on 1 day of vac...
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Headaches daily on an off, specifically left eye, for approximately 10 days starting on 1 day of vaccine Diarrhea approximately 14 days starting on day 1 Dizziness on and off for approximately10 days starting on day 1 Rheumatoid arthritis flare up, left shoulder 2 days, unable to move shoulder, day 7 & 8 after vaccine Small rash on left chin starting day 10 after vaccine Was seen by my primary care physician on day 11. Was advised to restart my hyrdroxychoroquin medication 200mg 2x's daily for rheumatoid arthritis ( I had not been taking this for several months) Was given Medrol dose pack which was started on day 15 after vaccine All symptoms subsided after finishing Medrol pack. I continue to stay on the Hydroxychloroquin 200mg 2X's daily for rheumatoid arthritis I was advised by my physician not to receive the 2nd dose Was advised to get J&J vaccine when available (I find this questionable)
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| 58 | 2021-01-27 | nausea | IMMEDIATELY DEVELOPED FLUSHING, NAUSEA AND DIZZINESS. |
| 58 | 2021-01-28 | diarrhea |
I became ill the next day, with severe body aches, low grade fever, headaches. 2 days later, I had ...
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I became ill the next day, with severe body aches, low grade fever, headaches. 2 days later, I had diarrhea and developed a cough. I was tested and was positive for Covid.
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| 58 | 2021-01-29 | vomiting, diarrhea, abdominal pain upper, nausea |
sore arm, fever up to 102, chills, body aches and pains, severe nausea, vomited x1, stomach cramps, ...
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sore arm, fever up to 102, chills, body aches and pains, severe nausea, vomited x1, stomach cramps, diarrhea x2 - total severe symptoms lasted about 24 hours, but total symptoms lasted 60 hours
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| 58 | 2021-01-30 | vomiting |
After being observed for approximately 20 minutes and patient walked to her car without assistance I...
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After being observed for approximately 20 minutes and patient walked to her car without assistance I was called to assess the patient in the parking lot for troubles breathing. EMS was called as I made my way outside. Upon my arrival patient was leaning out of the car and stating that she could not breath. She was able to tell me that she was allergic to penicillin. Oxygen was immediately placed on the patient with minimal relief. Lung sounds were coarse throughout. She then began to vomit about every 20-30 seconds. Epipen was administered in the right leg with no relief. Patient continued to complain of troubles breathing and vomiting. A second epipen was administered in the patients right arm again with no relief. A few minutes later patient was given racemic epinephrine through the oxygen mask. There appeared to be mild improvement in her breathing as she appeared more comfortable, but still complaining of shortness of breath and vomiting. When EMS arrived patient was unable to transport herself to the stretcher. When EMS and clinical staff transferred patient to the stretcher she became unresponsive. She appeared to still be breathing. She did not respond to verbal stimuli. Per ED report large amount of fluid was suctioned from the patients lungs following intubation in the ambulance. When patient arrived to the ED she was extubated and re-intubated without difficulty and further fluid was suctioned. At that time patient was found to be in PEA, shock was delivered. Shortly thereafter no cardiac activity was found and patient pronounced dead.
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| 58 | 2021-01-31 | nausea, vomiting | After receiving 2nd dose of Pfizer Vaccine, I am experiencing nausea, vomiting and a headache. |
| 58 | 2021-01-31 | vomiting |
Face swelling, fever, vomiting muscle and joint pain. I also have what looks like hives on my eyelid...
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Face swelling, fever, vomiting muscle and joint pain. I also have what looks like hives on my eyelid. I?ll still achy.
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| 58 | 2021-01-31 | difficulty swallowing | Metalic taste in throat Burning in chest lips swelling tongue swelling with swallow difficulty |
| 58 | 2021-01-31 | nausea | Nausea |
| 58 | 2021-01-31 | abdominal discomfort |
Pfizer-BioNTech COVID-19 Vaccine Low grade fever, chills, body ache, swollen lymph nodes, headache,...
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Pfizer-BioNTech COVID-19 Vaccine Low grade fever, chills, body ache, swollen lymph nodes, headache, tired, upset stomach and blisters on my tongue
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| 58 | 2021-01-31 | diarrhea |
She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Dia...
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She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Diarrhea; She felt really bad; She experienced what felt like "a very bad cold"; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3302), via an unspecified route of administration at site of right arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included fibromyalgia from 2018 and ongoing, borderline diabetes from Feb2020 and ongoing. Concomitant medication included ongoing duloxetine for fibromyalgia, ongoing meloxicam for fibromyalgia, ongoing semaglutide (OZEMPIC) for borderline diabetes. Clinical course: After vaccination, Patient felt fine the first couple of days. On 15Jan2021, she experienced what felt like "a very bad cold", she had a severe headache. She also had diarrhea, a sore throat and she felt really bad on 16Jan2021. It was controlled with taking paracetamol (TYLENOL). Paracetamol made her headache better when she took it. On 18Jan2021, she felt a bit of congestion, an earache and really bad fatigue. She didn't know if these are side effects from the vaccines and if so, how long will last. The episodes of diarrhea came and went. Her sore throat is not as bad. She also had a runny nose and body aches on 17Jan2021. She received the vaccine because she worked as a front-line worker as a dental assistant. She felt like she has the symptoms of COVID. The outcome of event a very bad cold, felt really bad, body aches and earache was unknown; of events fatigue and runny nose was not recovered; of rest events was recovering.
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| 58 | 2021-02-02 | nausea |
feel unwell most of the day; extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only wo...
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feel unwell most of the day; extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day; pain in injection site, spread within 6 hours to all joints; pain in injection site, spread within 6 hours to all joints; headache; severe pain all muscles; nausea; This is a spontaneous report from a contactable other health professional (patient herself). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 31Dec2020 12:30 in right arm at single dose for covid-19 immunization. Medical history included asthma, fibromyalgia, perimenopause issues. The patient was known allergies: amlodipine; yellow jackets/hornets. The patient had COVID-19 prior vaccination. No other vaccine in four weeks were taken. Concomitant medication in two weeks included fluticasone propionate, salmeterol xinafoate (ADVAIR), zolpidem tartrate (AMBIEN), estradiol, mepolizumab (NUCALA) and oxycodone. Facility type vaccine was nursing home/senior living facility. On 01Jan2021, patient experienced pain in injection site, spread within 6 hours to all joints, then within 24 hours had headache, severe pain all muscles, nausea, and extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day. All symptoms persist. Day 18 not in bed, but patient felt unwell most of the day on 18Jan2021. Lots of rest was required not normal for her. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included COVID-19 antibody test: positive on an unspecified date and nasal swab: negative on 15Jan2021. No treatment was received for events. Outcome of events at the reporting time were recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fatigue and other reported events due to temporal relationship. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-02-03 | nausea | FEVER, BODY ACHES, CHILLS, HEADACHE, NAUSEA |
| 58 | 2021-02-03 | decreased appetite |
Received Shot at 9 am worked all day and was fine. Arrived home at 5:30pm same day had chills and Ac...
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Received Shot at 9 am worked all day and was fine. Arrived home at 5:30pm same day had chills and Aches all over and couldn't get warm (teeth chattering cold) also having dinner and couldn't eat much and was burping up dinner but never got sick. then the fever hit around 7pm 99.9 then elevated and through out the night took temperature. The highest got to 102.7. Had bad stabbing pains in the top of my head. Didn't take anything until 9 am next day was trying not to because they said if you can hold off so finally I couldn't take it anymore and I took 1000mg Tylenol. It helped, my fever is lower now 11:50 am but still not feeling well and have a slight headache.
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| 58 | 2021-02-03 | nausea |
nausea; Feels tired; anxiety; This is a spontaneous report from a contactable pharmacist. A 58-year-...
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nausea; Feels tired; anxiety; This is a spontaneous report from a contactable pharmacist. A 58-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1284), intramuscular (left arm), on 23Dec2020 18:00, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported nausea, but it went away, feels tired and after conversation, possibly just anxiety. These adverse events started on 23Dec2020 18:00. No treatment was received for the events reported. The patient recovered from the events on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. The COVID call center advised to return to work.
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| 58 | 2021-02-03 | abdominal pain |
white mucous stools with blood; abdominal pain; tenesmus; white mucous stools with blood; fatigue; c...
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white mucous stools with blood; abdominal pain; tenesmus; white mucous stools with blood; fatigue; chills; headache; temp 99.5; This is a spontaneous report from a contactable nurse. This 58-year-old female Nurse (Patient) reported that A 36-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19 pfizer, Lot#: EL3246), via an unspecified route of administration on 11Jan2021 01:00 PM on Right arm at single dose for COVID-19 immunisation. She is not pregnant. Medical history was none. Known allergies: NKA. Facility type vaccine was other. No other vaccine in four weeks. Concomitant medications included thyroid (ARMOUR THYROID), estrogens conjugated/medroxyprogesterone acetate (PREMPRO), Regular vitamin. 4:00 am on 20Jan2021 woke with abdominal pain, tenesmus, white mucous stools with blood, fatigue, chills, headache, Temp 99.5 called physician told it sounds like reaction. Took Tylenol 500 mg for symptoms. 21Jan2021 feel better but still mucous blood stools dr wants to see me monday 25Jan2021 if still having blood. AE resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with lasting effects. Treatment received. No COVID prior vaccination. No COVID tested post vaccination.; Sender's Comments: Based on the information currently available and in absence of strong confounding factors, a possible contributory role of the suspect BNT162B2 in triggering the onset of blood stool cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-02-04 | nausea |
Rigors, low grade temp (99.7), body aches, headache, and nausea. From approximately 0100 , fever b...
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Rigors, low grade temp (99.7), body aches, headache, and nausea. From approximately 0100 , fever broke about noon.
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| 58 | 2021-02-04 | nausea |
Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am Hospita...
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Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am Hospitalized on 2/3 @ 11:30 am on 2/3/2021 2/5 @ 4 :30 pm Primary Care visit @ 3:30 pm on 2/5/2021
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| 58 | 2021-02-04 | abdominal pain, nausea |
Systemic: Abdominal Pain-Severe, Systemic: Nausea-Severe, Systemic: Other- High blood pressure and h...
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Systemic: Abdominal Pain-Severe, Systemic: Nausea-Severe, Systemic: Other- High blood pressure and heart rate
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| 58 | 2021-02-04 | nausea |
feeling nauseous from the first dose of vaccine; shoulder hurting; This is a spontaneous report from...
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feeling nauseous from the first dose of vaccine; shoulder hurting; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231), via an unspecified route of administration on 20Jan2021 at 12:30 on the left arm at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she was feeling nauseous from the first dose of the vaccine. She called to find out how long she will be nauseous because this is the second day. The patient stated that she started feeling nauseous about 15 minutes after. The only other symptom is her shoulder hurting since an unspecified date in Jan2021. The patient added that she still feels nauseous. The outcome of the event feeling nauseous from the first dose of vaccine was not recovered while the outcome of the event shoulder hurting was unknown. The case was reported as non-serious.
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| 58 | 2021-02-05 | diarrhea, abdominal pain | 100 degree fever, headache, abdominal pain, muscle aches, fatigue, diarrhea |
| 58 | 2021-02-05 | decreased appetite |
Two hours after injection severe soreness, next day loss of range of motion, persistent pain around ...
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Two hours after injection severe soreness, next day loss of range of motion, persistent pain around shoulder, radiating pain down arm and tingling in fingers which continues into sixth day. Unable to sleep, loss of appetite, taking Tylenol prn, was taking Motrin prior.
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| 58 | 2021-02-06 | nausea |
Severe headache, backache all over body aches Nausea Fever Chills Fatigue Site of injection 2 day...
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Severe headache, backache all over body aches Nausea Fever Chills Fatigue Site of injection 2 days after: red, hot, swollen and itching
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| 58 | 2021-02-08 | vomiting, nausea | Violent shivers, brutal headache, nausea, vomiting, fever |
| 58 | 2021-02-09 | nausea |
Pfizer COVID vaccine, symptoms still evolving and mimic COVID but negative COVID test. Have lost abi...
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Pfizer COVID vaccine, symptoms still evolving and mimic COVID but negative COVID test. Have lost ability to walk without a walker, severe weakness, fatigue, dizzy, distortion in hearing, metellic taste, body aches and joint pain, intermittent headache and nausea. No fever no cough.
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| 58 | 2021-02-09 | vomiting |
Vomiting; Phlegm; Headache; Dizziness; This is a spontaneous report from a contactable consumer (pat...
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Vomiting; Phlegm; Headache; Dizziness; This is a spontaneous report from a contactable consumer (patient). This 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number unknown), via an unspecified route of administration at single dose in the left arm on 20Jan2021 14:00 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took hydrocodone and experienced drug allergy. On 20Jan2021 15:00, the patient experienced vomiting, phlegm, headache, dizziness. No treatment required. The outcome of the events was recovered on an unspecified date in Jan2021.The patient had not had symptoms associated with COVID-19 prior vaccination. The patient had not been tested for COVID-19 post the vaccination. The patient was not pregnant at the time of vaccination. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
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| 58 | 2021-02-11 | difficulty swallowing | facial/ tongue swelling, hives, shortness of breath, trouble swallowing |
| 58 | 2021-02-22 | nausea, diarrhea |
Nausea, Diarrhea, Headache (4 weeks), Joint Pain (Ongoing), Injection Site Injury - Skin Discolorati...
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Nausea, Diarrhea, Headache (4 weeks), Joint Pain (Ongoing), Injection Site Injury - Skin Discoloration/Scab (On Going), Pain Injection Site (Ongoing)
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| 58 | 2021-02-23 | diarrhea, difficulty swallowing |
Within a few minutes of vaccination, flushing/sweating, throat swelling to a level of discomfort wi...
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Within a few minutes of vaccination, flushing/sweating, throat swelling to a level of discomfort with swallowing. I took 1 Benadryl and then another 15 minutes later, then drove home once rxn seemed to stabilize. Took 2 more Benadryl through the course of the evening as flushing stopped but still had throat discomfort and new headache. Also took Tylenol. In AM, allergic symptoms were resolved, but had significant arm pain (upper arm around site was very firm and warm to the touch), mild headache, moderate fatigue, and diarrhea. This continued for another 24 hours. Took Tylenol 3 times. Felt fine by Wednesday (2 days after vaccination).
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| 58 | 2021-02-25 | diarrhea |
Fatigue, body aches, joint pain, feeling overly warm accompanied by sweating on face, headache, diar...
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Fatigue, body aches, joint pain, feeling overly warm accompanied by sweating on face, headache, diarrhea, mostly FATIGUE
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| 58 | 2021-02-25 | nausea |
PATIENT FEELS NAUSEATED. CHECK BLOOD SUGAR, ADDITIONAL 15 MINUTES ADDED TO TIMER. NO APPARENT DISTR...
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PATIENT FEELS NAUSEATED. CHECK BLOOD SUGAR, ADDITIONAL 15 MINUTES ADDED TO TIMER. NO APPARENT DISTRESS. FINGERSTICK BS IS 65. A COKE AND CHEESE CRACKERS WAS GIVEN TO PATIENT. PATIENT IS BETTER WITH NO NAUSEA. DAUGHTER IS A NURSE WHO WILL RE-CHECK BLOOD SUGAR AT HOME. TEN MINUTES PATIENT WANTED TO LEAVE.
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| 58 | 2021-02-25 | vomiting |
continues vomiting; developed Migraine headache and is gotten worse ever since; This is a spontaneou...
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continues vomiting; developed Migraine headache and is gotten worse ever since; This is a spontaneous report received from a contactable consumer (patient's husband). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 25Jan2021, at single dose, for COVID-19 immunization. The patient medical history concomitant medications were not reported. It was reported that the patient got the COVID-19 shot in the morning of 25Jan2021 (yesterday) which developed into a migraine headache that has done nothing but gotten worse and on 26Jn2021, she had continued vomiting. The reporter asked if these were normal and how long will these last. The outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 58 | 2021-02-26 | abdominal pain upper, abdominal distension |
Idiosynchratic Pancreatitis Started to feel radiating severe pain in my back that accompanied severe...
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Idiosynchratic Pancreatitis Started to feel radiating severe pain in my back that accompanied severe bloating and pain in the stomach area. Tried Gas-x, pain meds, mineral water. Went into the emergency room at MCR at 3 am. Received blood work, ultrasound and a CT scan. The results were the Pancreatitis. I was sent home with Zophran, and hydrocodone and instructions to be on a clear liquid diet for 48 hours. Released from the ER around7:30 am on Feb 27, 2021
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| 58 | 2021-02-26 | nausea | Weak, dizzy, nausea, shoulders ache, cleared by medics |
| 58 | 2021-02-27 | vomiting, nausea | Nausea, vomiting, high fever, horrible headache |
| 58 | 2021-02-27 | nausea |
Per the patient, she received her 2nd COVID vaccine on 2/17/21 around 9:00 am. She woke the next mo...
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Per the patient, she received her 2nd COVID vaccine on 2/17/21 around 9:00 am. She woke the next morning on 2/18/21 with severe "brain fog", exhaustion, dizziness, headache and nausea. This was severe enough to cause her to "not be able to complete a sentence by 2/22/21. She was taken to the ER at hospital for evaluation and then had follow up with me on 2/23/21 and again 2/28/21. Most of her symptoms are dramatically improved now other than the exhaustion. She still has minor headaches and occasional dizziness, but these are improved. Thus, this feeling has been present for 11 days after her vaccine. She had similar symptoms to a much lesser extent lasting 4 days after her first vaccine (also Pfizer given the same location on 1/27/21 EL3247). She returned to her baseline health in between.
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| 58 | 2021-03-02 | vomiting, diarrhea | Chills x 3 days and then fever, emesis, diarrhea and shortness of breath |
| 58 | 2021-03-02 | difficulty swallowing |
Swollen tongue, tingling and pain in tongue, difficulty swallowing, heaviness in chest and upper bac...
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Swollen tongue, tingling and pain in tongue, difficulty swallowing, heaviness in chest and upper back within 5-10 minutes of injection 1-2 days after, continued tingling, pain, and swelling in tongue, hives/rash on face with itching and difficulty swallowing Benadryl was administered at the testing site. Continued Benadryl with Zyrtec and Pepcid daily for adverse reaction through 3/3/21. Called PCP?have appt 3/4/21.
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| 58 | 2021-03-03 | nausea | Nauseated, elevated HR, resolved after drinking water and waiting. Evaluated by EMS-Cleared |
| 58 | 2021-03-04 | nausea | Dizzy, nauseous, headache, fatigue, muscle aches, site soreness no redness. |
| 58 | 2021-03-04 | nausea, vomiting |
Pain on my extremities, unable to hold things with my hands, pain going down my left leg , pain from...
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Pain on my extremities, unable to hold things with my hands, pain going down my left leg , pain from my neck down my arms, deep depression, strong flare up of my Fibromyalgia and Arthrities together, Severe Headaches and very weak no energy at all and vomiting, nauseated. Dr. stated the shot case a neurological disorder causing the reaction stated above.
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| 58 | 2021-03-04 | difficulty swallowing, nausea |
Pulse in 160s ... leveled at 150 ... dizziness, confusion, feeling faint, nausea, chest pain, hard t...
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Pulse in 160s ... leveled at 150 ... dizziness, confusion, feeling faint, nausea, chest pain, hard to swallow, hard to breath. Taken to ER via ambulance.
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| 58 | 2021-03-04 | nausea | Taking Aleve and drinking lots of Water |
| 58 | 2021-03-14 | vomiting |
First chills; Vomiting; body aches; Head still doesn't feel normal; severe dizziness; head pressure;...
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First chills; Vomiting; body aches; Head still doesn't feel normal; severe dizziness; head pressure; This is a spontaneous report from a contactable consumer. A 58 -year-old female (not pregnant) patient received her first dose on an unspecified date, second dose (lot number: EN2601) on 12Feb2021 of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), both via an unspecified route of administration (at the age of 58 -years-old), single dose for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication included clonazepam. The patient experienced First chills, vomiting, body aches, head pressure, severe dizziness and vomiting. Head still doesn't feel normal (The events were reported also to happen then 12 days later), all events started 23Feb2021 0600. The outcome of the events was recovering. The events were reported to cause 3 days hospitalization. No other vaccine in four weeks. AE Treatment: Meclizine, Zofran, EKG, MRI, CT of head. The patient had a covid swab test on 23Feb2021 with negative result.
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| 58 | 2021-03-17 | decreased appetite |
extremely weak; right shoulder pain; temp started rising & by 2PM it was up to 102.4; legs were like...
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extremely weak; right shoulder pain; temp started rising & by 2PM it was up to 102.4; legs were like jelly; felt unsteady & like I would fall; felt so bad/felt awful/talking about end of life wishes; no appetite; chest tightness; This is a spontaneous report from a contactable other health care professional reported for herself. A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 09Feb2021 16:30 (at the age of 58-year-old) at single dose in left arm for covid-19 immunization. Medical history included Heart Failure, Sarcoidosis, Asthma, Obesity and Covid from Apr2020 to an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included prednisone, carvedilol (COREG), spironolactone (ALDACTONE), hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ). The day of injection on 09Feb2021 at 16:30 PM that same night 8 pm the patient started experiencing some chest tightness. Since the patient live in country when she left work(hospital). At that point she took 50mg of P.O. benadryl (diphenhydramine). So the patient just took time and hung around town. She went to family dollar then publix. She felt better at 9 pm so and went home. The next morning (on 10Feb2021 her legs were like jelly when she woke up to go to bathroom. She felt unsteady and like she would fall. Next thing she just felt so bad and no appetite so she ate nothing that day. Her temp started rising and by 2PM on 10Feb2021 it was up to 102.4, the patient felt so awful then the feeling of doom set in so she was talking about end of life wishes. She had Covid back in Apr2020 and it was like reliving it again. On 11Feb2021 she felt better but had to call out low grade 99.4 only she was able to eat some but extremely weak and right shoulder pain (moderate). Friday (on 12Feb2021) she went to work but still felt weak. She felt better over the weekend (Feb2021). Here we were 17Feb2021 and still not completely there but 90% better. The adverse events result in doctor or other healthcare professional office/clinic visit. No treatment received for other adverse event. The patient underwent lab tests and procedures which included body temperature: 102.4 on 10Feb2021, body temperature: 99.4 on 11Feb2021, Nasal Swab Covid-19/SARS: negative on 16Feb2021. The outcome of the events was reported as recovered in Feb2021. Information on the lot/batch number has been requested.
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| 58 | 2021-03-21 | appendicitis, nausea |
acute appendicitis/severe abdominal pain; 102 fever; body aches; chills joint pain; chills joint pai...
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acute appendicitis/severe abdominal pain; 102 fever; body aches; chills joint pain; chills joint pain; headache; nausea; Severe arm pain; feeling of unwell set in; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 28Feb2021 (Batch/Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included Sjogren's syndrome, mixed connective tissue disease, COVID-19 from Mar2020. Patient was not pregnant. Patient had no known allergies. Concomitant medications included estrogens conjugated (PREMARIN), tizanidine, hydroxychloroquine, acyclovir [aciclovir], all taken for an unspecified indication, start and stop date were not reported. 4 hours later (28Feb2021 20:30), severe arm pain & feeling of unwell set in. 24 hours later (01Mar2021 16:30) 102 fever, body aches, chills joint pain, headache and nausea for 15 hours and although it improved, patient never felt back to normal. Day 10 (10Mar2021 19:00) patient started having severe abdominal pain, nausea, headache and body pains. Day 11 (11Mar2021) it was worse and day 12 (12Mar2021) patient went to ER and was diagnosed with acute appendicitis and had surgery for appendix removal. Patient feel the vaccine caused this as patient had no issues that would allude to a problem and after receiving the vaccine never felt good. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Patient was hospitalized for 1 day. Patient had nasal swab: negative on 12Mar2021. Outcome of the events was resolving.
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| 58 | 2021-03-22 | vomiting, diarrhea |
faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a co...
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faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 16:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as health clinic. Relevant medical history included overweight from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) and omeprazole (PRILOSEC); both were taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 05Mar2021 at 21:15, the patient experienced faint, blurred vision, vomit, diarrhea, hot sweats, and weakness. The patient did not receive any treatment for the adverse events (AE). The patient was recovering from all the events. Information on the batch/lot number has been requested.
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| 58 | 2021-04-01 | decreased appetite, nausea |
3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours afte...
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3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours after vaccination - chills, body ache, headache, lethargy. 3/23/2021 - woke with nausea and anorexia, took triple usual hydrocortisone dose (30mg) with yogurt, very lethargic, brain fog with cognitive difficulty, anorexia, stayed in bed all day, eating drinking veyr little. 3/24/2021 - woke with worsening lethargy, generalized weakness, nausea, took hydrocortisone 30mg with yogurt. by noon, very dizzy and weak, unable to get out of bed, friend drove her to Hosp. Emergency Room. Noted hypotension systolic BP 80, clinically dehydrated, Na 129, K 3.2, cr 1.2 (nl 0.97) Diagnosed Adrenal Crisis admitted 3 days to 3/27
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| 58 | 2021-04-02 | abdominal pain |
On the afternoon after receiving my first vaccine dose (March 25) I began to notice abdominal crampi...
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On the afternoon after receiving my first vaccine dose (March 25) I began to notice abdominal cramping and a pain on my right lower abdomine...this pain and cramping increased and 5 days later (march29) I sought medical atten at Urgent care. They referred me for ct scan and blood work at hospital where it was determined that I need to have my appendix removed. Which is what they did.
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| 58 | 2021-04-05 | difficulty swallowing |
I woke up early morning throat had no saliva, no sore throat. I dint had a temperature and got up t...
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I woke up early morning throat had no saliva, no sore throat. I dint had a temperature and got up to get some water. The next day I woke up the same way went to work. While at work had to tilt my head to swallow my water. On Saturday I woke up same symptoms drove myself to ER. Since my first dose I have to wake up at every night to drink water. This has never happened before Dose 1.
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| 58 | 2021-04-05 | appendicitis |
Patient was admitted to the hospital for acute appendicitis on 3/29. She subsequently required respi...
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Patient was admitted to the hospital for acute appendicitis on 3/29. She subsequently required respiratory support with high flow nasal cannula and remains admitted currently (4/6/21)
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| 58 | 2021-04-06 | nausea, vomiting |
Nausea; Vomiting; Achy muscles and joints; Achy muscles and joints; I had no energy; This is a spont...
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Nausea; Vomiting; Achy muscles and joints; Achy muscles and joints; I had no energy; This is a spontaneous report from a contactable consumer reported for self. A 58-year-old female patient (No pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:30 PM (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included lupus. The patient did not have covid prior vaccination, no covid tested post vaccination, and did not have Known allergies. Concomitant drug was reported as too many to list. The patient experienced nausea, vomiting, achy muscles and joints, and she had no energy on 25Mar2021 03:00 AM with outcome of not recovered. All events considered serious due to Disability or permanent damage. No treatment received for the events. This has lasted for 5 days as of this date.
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| 58 | 2021-04-08 | difficulty swallowing |
Throat swollen could not swallow after 5 minutes of injection; This is a spontaneous report from a c...
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Throat swollen could not swallow after 5 minutes of injection; This is a spontaneous report from a contactable nurse. A 58-year-old non-pregnant female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL3248), via an unspecified route of administration, administered in right arm on 01Feb2021 11:30 as single dose for an unspecified indication. The patient medical history was not reported. Concomitant medications included thyroid (ARMOUR THYROID) (MANUFACTURER UNKNOWN); estrogens conjugated, medroxyprogesterone acetate (PREMPRO) (MANUFACTURER UNKNOWN); vitamins nos (MULTIVITAMIN [VITAMINS NOS]) (MANUFACTURER UNKNOWN). The patient previously took BNT162B2 (product=COVID 19, brand= pfizer, lot number=EL3246, administration date=11Jan2021, administration time=01:00 PM, vaccine location=Right arm, dose number=1). The patient experienced throat swollen could not swallow after 5 minutes of injection on 01Feb2021 11:45. Therapeutic measures were taken as a result of throat swollen could not swallow after 5 minutes of injection which included IV solumedrol, pepsid, epinephrine, benedryl. The clinical outcome of the throat swollen could not swallow after 5 minutes of injection was recovered on an unspecified date in Feb2021. No follow-up attempts are possible.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Swallowing difficult cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-04-09 | vomiting, decreased appetite |
developed acute delirium; redness in arm; Right arm swelling; After that very wild, I was screaming....
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developed acute delirium; redness in arm; Right arm swelling; After that very wild, I was screaming. Very scary. My memory was gone; she passed out at home; she is very depressed has anxiety; she is very depressed has anxiety; panic attack; gained 16 pounds; vomited; loss of appetite; body ache/pain; This is a spontaneous report from a contactable Other HCP (patient). A 58-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: NN6206 and expiration date: Not available), via an unspecified route of administration in the right arm on 04Mar2021 12:00 as a single dose for COVID-19 immunisation. Medical history included removed brain tumor, she has sciatic nerve damage on left arm and left leg and is paralyzed, coma, chronic body aches, seizures, bad vision, high blood pressure and three brain surgery, short term memory. The patients historical vaccine included Flu vaccine injection in right arm deltoid muscle. The patient's concomitant medications included Oxycodone (5mg three times a day tablet) been taking for 3 years since she has brain tumor removed and for chronic body aches and Lyrica. On an unknown date, the patient gained 16 pounds. In Mar2021, the patient experienced she passed out at home and she was very depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite. On 04Mar2021, the patient experienced right arm swelling, screaming, scary, memory was gone. On an unknown date, she experienced developed acute delirium. On 06Mar2021, the patient had redness in arm. The patient was in the hospital for 4 days and was admitted on 14Mar2021. Her memory came back little by little and side effect of vaccine it says that if she had side effects from first one do not take second dose because it is worse and she is scared to be admitted to the hospital and does not want to experience that again. She was taking pain medication and did not tell her she cannot take Tylenol of course with body aches they did not tell her. It was not specific acute delirium it is a psychiatric disorder and she was wild and has never been like that before, she was tied up to the bed. The reporter states that she is disabled. She has bad vision and she is by herself at home. She is 5 1/2 already going down. She is not going to get the second one until get report results because it is ridiculous, and she is very nervous as she was admitted at night to the hospital. Body ache happened 24 to 36 hours after vaccine not that severely unusual as it went away, and she has a chronic illness and is in a wheelchair from chronic pain. Reporter stated she could not swallow liquid or eat food and she was scheduled for a cat scan, but she could not go since she has been on the phone with Pfizer to get truth and fairness. Reporter stated yesterday this started getting better. Reporter stated was discharged from hospital last Tuesday but had pain at home. Developed acute delirium: stated when she woke up in the ER the next day in few hours she was admitted and in the ER she was crazy and tried running even though she cannot run because she is paralyzed and she did not remember nothing. Reporter stated no she did not get it that when she was discharged, it had been 48 hours. Pain started 48 hours after the vaccine. She has chronic pain the pain is not that excruciating, and it has stopped. She could not remember what happened but just knew it was redness and hurt a lot. Her memory and everything came back. States she had MMR (as provided by Reporter ) done, because of pain in her whole body and everything came back negative. She had terrible pain, she asked to be given pain medication, and was given pain medication. Reporter stated it disappeared about one week now it disappeared and has recovered completely. Reporter stated black and blue inflammation and it does not hurt and the pain it went away. She was discharged from the hospital and discharge paper said second vaccine on 26Mar2021. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The patient did not take any vaccines with 4 weeks. No Relevant Tests were performed. While providing an AE for the COVID vaccine she took Tylenol and Motrin as treatment, on top of it, but the pain didn't go away. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The clinical outcome of events gained 16 pounds, passed out at home, depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite, right arm swelling, screaming, scary, developed acute delirium, redness in arm was unknown whereas of memory gone it was recovering/resolving.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events peripheral swelling, amnesia, delirium, loss of consciousness, depression, anxiety, panic attack, and erythema and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-04-17 | nausea, abdominal pain upper |
facial drooping; chills; nauseated; tired; stomach cramping; a little wheezy; This is a spontaneous ...
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facial drooping; chills; nauseated; tired; stomach cramping; a little wheezy; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), dose 1st via an unspecified route of administration, administered in Left arm on 23Mar2021 14:00 as single dose for covid-19 immunisation. Medical history included Immunocompromised. Concomitant medications included levothyroxine sodium (SYNTHROID), amlodipine, eszopiclone (LUNESTA), rabeprazole. The patient previously took hydrocodone, oxycodone, augmentin and experienced Known allergies. On 24Mar2021 13:00, patient experienced facial drooping, chills, nauseated, stomach cramping, tired, a little wheezy. There was no treatment received for the adverse events. The patient had no COVID prior vaccination and nasal swab was tested post vaccination. The outcome of the event was recovering.
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| 58 | 2021-04-24 | difficulty swallowing |
Hard to swallow; Voice went hoarse; Scalp itched/ Insider ear canals itched; face went numb; This is...
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Hard to swallow; Voice went hoarse; Scalp itched/ Insider ear canals itched; face went numb; This is a follow-up spontaneous report received from a contactable consumer (patient). A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscularly, administered in left arm on 24Feb2021(at the age of 58 years old) at 16:15 (Batch/Lot Number: EM9809) as a single dose for COVID-19 immunization. Medical history included ongoing asthma (10 years) and ongoing fibromyalgia (40 years). Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient previously received dose 1 of BNT162B2 intramuscularly in the left arm on 03Feb2024 at 16:00 (Batch/Lot number: EL9262) and 1 hr. after dose, tongue, lips and cheeks went numb. Last 30 min went away (recovered same day). On 24Feb2021, 5min after 2nd dose, her face went numb, it was hard to swallow, her voice went hoarse, her scalp itched, and inside inside ear canals itched. She called over paramedics who monitored me for an hour. The events did not get worse and she went home. After 2 and half hours passed since getting the vaccine, all events resolved (on 24Feb2021) except itch (not recovered). She took Benedryl and woke up fine. The patient assessed the Pfizer product had a causal attribution to the events. The reporter assessed the events as medically important. No follow-up attempts are possible. No further information is expected.
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| 59 | 2021-01-01 | decreased appetite |
Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore a...
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Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore arms, fatigue then started getting brain fog , HA, body aches until current. my MD and I thought it was due to vaccine. Then add loss of taste and appetite on 12/30/20 along with rest of symptoms. I knew then I needed to get swab. Symptoms is still current.
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| 59 | 2021-01-03 | diarrhea | diarreah since day two after the vaccination |
| 59 | 2021-01-04 | vomiting, nausea |
Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea ...
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Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea and numbness and tingling in fingertips 5 minutes after administration of vaccine and proceeded to bathroom. Patient with unwitnessed vomiting prior to RN assessment. RN assessed patient and taken safely to private evaluation room. AED pads applied per protocol. Epi-Pen administered. EMS called. Vital signs stable. Patient complained of itching and erythema in left arm around injection site. MD evaluated patient and advised to be further assessed in ER. Patient continuously evaluated by RN and EMS. Patient transported to ER in stable condition.
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| 59 | 2021-01-04 | vomiting, diarrhea, nausea |
Fatigue, sinus pain, nausea , vomiting , Chills, Body Aches, Fever. Headache, Diarrhea, runny nose ...
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Fatigue, sinus pain, nausea , vomiting , Chills, Body Aches, Fever. Headache, Diarrhea, runny nose Tenderness at the injection site.
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| 59 | 2021-01-04 | diarrhea |
Fine raised red rash over her body; throat swelling; diarrhea; high pitched cough productive with cl...
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Fine raised red rash over her body; throat swelling; diarrhea; high pitched cough productive with clear thin secretions; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on left arm from at 12:30 PM on 23Dec2020 at single dose for COVID-19 immunization. Medical history included depression. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), triazolam (HALCION), fluoxetine hydrochloride (PROZAC), paracetamol (TYLENOL). The patient previously took Lamictal and experienced rash, codeine and experienced hallucination, lamictal for drug allergy, codeine and experienced drug allergy. On 24Dec2020 mid-day (11:00 AM), the patient developed the following S/S (signs and symptoms, which were similar to a Lamictal rash): Fine raised red rash over her body, but significantly heavier to face, neck and lower legs; throat swelling with a high pitched cough (with no difficulty breathing) productive with clear thin secretions; diarrhea. The patient took 6 Benadryl every 4-6 hours, Pepcid twice daily, and had an epi pen available (but did not need it). The cough and rash resolved by late Sunday evening (27Dec2020). The patient did not report to ED because she felt the symptoms were manageable at home. All events reported as non-serious. The outcome of events red rash and cough were recovered on 27Dec2020, the outcome of rest events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19.
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| 59 | 2021-01-04 | nausea |
Patient states to feeling nauseated and had tingling in the arm and hand. Patient was sent to the ED...
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Patient states to feeling nauseated and had tingling in the arm and hand. Patient was sent to the ED to rule out TIA but left before being evaluated. Patient states symptoms have resolved and did not want to be seen by ED physician. Patient was educated on returning back to ED with any new concerns.
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| 59 | 2021-01-04 | abdominal discomfort |
Very tired; Cold/head cold; upset stomach; she was not feeling well; it got her all congested and sh...
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Very tired; Cold/head cold; upset stomach; she was not feeling well; it got her all congested and she got the head cold in Dec2020; little whooping cough; I had severe headaches and it was just too uncomfortable; my head was so congested; worst headache; it was just too uncomfortable; This is a spontaneous report from a contactable consumer(patient). A 59-year-old female patient received BNT162B2 via an unspecified route of administration on 22Dec2020 at the 59-year-old at single dose for Covid virus. The medical history included Congested, head cold and Covid virus. There was no concomitant medication. The patient work at a hospital and she went for a Covid shot (clarified as Covid 19 vaccine) on 22Dec2020 and she got a very bad reaction from it which bothered her, she had severe headaches in Dec2020 and it was just too uncomfortable and on 24th she was very tired, she didn't had too much of upset stomach in Dec2020 but it was not all that bad by 9 in the clock by morning she was at work and everything and she was told by if she was not feeling well she can walk by a day, but her question and her concern was back on November okay she had called in sick around, she had a funeral that she gone too and people that were at the funeral, unfortunately were smoking outside and smoke bothers me very much, she get congested and she get head cold from it you know and I was thinking it's nothing it's just a cold and somebody told her no (name) you better go get yourself to the employee health office and get checked out and she didn't bother doing that, she said no it's just the cold she will be fine but then it just got worse down the road and she said to herself may be she better just to say she did it, so she called in sick on 24th because she had the cold still and she called and she went to employee health office on 25th she still had the headache and she still had the cold, however when she went to the health office they said to her well stay out of work and we will get back in touch with her and she said okay and she will do that so when they got back in touch with her they said they do have the Covid and she said ohhh she said okay so she stayed out of work and she went to work on the 07Dec so she was wondering whole time, so her confusion was this she was told if you already had the virus in her which at that time, she did not know what it was she just thought it was from cigarette smoke because it got her all congested and she got the head cold in Dec2020 and the whole thing that went along with it and the health employee officer know you had the virus and it's just the virus and she go oh great and that's when they told her to stay out of work and she said okay fine then she just have to that, so in the meantime everybody in the work said hi calling me checking up on her and she said it's so nice of you people, she appreciate it but then she went back to work she was still feeling you know much better than she was but she had little whooping cough in Dec2020 but that was not really that bad, so they said you going to get the shot or not, and she said she don't know she kind of debatable, she don't know if she should get it, because she work in the hospital or she should not get, she said she don't know she was kind of up and some people like she get it sometime your health was not that good but on the other hand everybody that is working here in the hospital working with patients because was work right in the ICU, all over the floor you know spreading right there so she said oh alright so she kicked myself and said go get the shot, get it just over with and get it out of here so that is when she took her shot that was on 22nd and on 24th she was very tired all day no she was tired all day but she was kind of dragging most of the day but she had on the 20th no that was fine on the 20th okay for some reason she guess it was after work that week on 19th, she came home and her head was so congested and she had the worst headache and she felt like a wand had hit her over the head, it was horrible and all she could smell was cigarette smoke, like is her neighbor smoking here so she went down the hall because in live in building that used to be hotel but now they turned that into Condominium and she walk up and down the hall and she was like was somebody smoking or why this or why smell this so strong and the all the lights off in a hallway and she don't want to offend anybody but they had to go to work and somebody elsewhere and she am like she can't stand this smell and they gave this shot and she went for this shot, and they told us to come back she think it was a week or something like that to get the second shot, and she am saying if this going to cost her going to feel this way again, she don't want to get the second shot, she told them that and they told her to call this number and talk to them.The only reason she got it because they encouraged to get it. Even though she had the Covid virus, people said if you already have the virus you don't need to get a shot but people were encouraging because that's she thought well she guess she will get it. But she was mad that she got because it made her sick in Dec2020. And because we already got it they want us to go back and get the second shot and what she was m trying to say to you is, without take and hour 3 hour of conversation here she just want to say she don't want to get back and get the second shot and if it is okay by you guys somehow send her a letter or whatever it is, whoever she have to talk to because she don't want to go back and get the second shot just because of getting sick. She took Excedrin because that works for my headache. She didn't understand why you need all this information history with all this when all she want to say was she didn't want to get a second shot. The outcome of events Head cold and Headache was not recovered, the other events was unknown. Information on the lot/batch number has been requested.
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| 59 | 2021-01-05 | nausea | Extreme Dizziness, Blurry Vision, Near fainting and Nausea |
| 59 | 2021-01-05 | nausea | Fever between 99.6-100 degrees fahrenheit for 24 hours. Weakness and mild nausea. |
| 59 | 2021-01-05 | diarrhea |
Woke up the following morning with terrible body aches, especially to upper back, neck, lower back a...
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Woke up the following morning with terrible body aches, especially to upper back, neck, lower back and legs. Headache, diarrhea, and tiredness. Was unable to "function", and slept most of the day. Was still having some of those symptoms the second day, but not as bad.
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| 59 | 2021-01-06 | abdominal pain upper, nausea |
stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore...
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stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore throat, mild headache, denies respiratory difficulties. States that with 1st vaccine had hives inside rt elbow and wrist,
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| 59 | 2021-01-07 | vomiting, nausea, nausea, vomiting |
3 weeks ago tomorrow, The day after my shot I was really tired. I went to bed and when I got up and ...
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3 weeks ago tomorrow, The day after my shot I was really tired. I went to bed and when I got up and had a fever, horrible joint and leg pain, horrible leg pain, terrible bouts of nausea until I couldn't puke anymore. I went into the ER and got fluids and they ran tests and everything was normal. ER said it could be a moderate reaction to the vaccine.
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| 59 | 2021-01-07 | decreased appetite |
CDC called and requested I complete this report, but I do see these reactions within the normal rang...
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CDC called and requested I complete this report, but I do see these reactions within the normal range reported to us prior to getting vaccine. 6 hrs after 2nd shot fever of 99, headache, and arm pain. 20 hrs after shot significantly worse headache, arm pain and fatigue to point of not getting up, not walking around, and not interested in eating until later in the day. 30 hrs after shot I was up and eating normally, but continued headache 46 hrs after shot but ibuprofen adequate to cover pain today.
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| 59 | 2021-01-07 | nausea, diarrhea, vomiting |
Low grade temperature that last 6 hours; Nausea; Vomiting; Diarrhea; Arm soreness; This is a spontan...
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Low grade temperature that last 6 hours; Nausea; Vomiting; Diarrhea; Arm soreness; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar events 6 patients. This is 2nd of 6 reports. A 59-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm on 29Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. This patient had a low grade temperature that last 6 hours, nausea, vomiting and diarrhea on 05Jan2021. She also experienced the arm soreness on 29Dec2020. patient says that they had employees get the COVID Vaccine on 29Dec2020. Most said that they maybe got a little arm soreness that lasted a few hours. They took tylenol and were fine. reporter confirmed that this patient is herself. She did not have a specific physician that she sees. She sees whoever is there that day. She received the vaccine on 29Dec2020. These symptoms hit her early this morning. They hit her, then she called out of work. She talked to her provider and they were going to revisit if they wanted to do another COVID test. she has already had two negative tests. Treatment was none. Patient states she just got off the phone completing a report of side effects from several of her employees that happened within 24 hours of receiving the Covid vaccine on 29Dec2020. reporter states several employees reported headaches, tiredness, and malaise. reporter would like to know if the onset and duration for these symptoms are expected. Her question it, since they all got the vaccine on 29Dec2020, would they be experiencing these side effects 7 days post injection, this far out. No Investigation Assessment. Patient was recovered from low grade temperature that last 6 hours, vomiting and diarrhea on 05Jan2021, recovered from arm soreness on 29Dec2020, recovering from nausea. Reporter seriousness of low grade temperature that last 6 hours, Nausea, Vomiting, Diarrhea and Arm soreness was not serious. The reporter considered the events Low grade temperature that last 6 hours, Nausea, Vomiting, Diarrhea and Arm soreness was related. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
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| 59 | 2021-01-07 | nausea |
Nausea; Migraine headache; Chills; Joint pain; This is a spontaneous report from a contactable Nurse...
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Nausea; Migraine headache; Chills; Joint pain; This is a spontaneous report from a contactable Nurse. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 30Dec2020 10:30 at Left arm at single dose for covid-19 immunization. Vaccine was administered at hospital and not administered at military site. Medical history included ongoing spondylolisthesis diagnosed 15-20 years ago and overweight. Her vertebrae were not in physical alignment. The patient was given steroids, but it didn't help. Steroids didn't do anything. There was no name or NDC/Lot/Exp of steroids. The patient no longer has steroids. Her back will hurt when she gains weight. Height was now under 5 feet 5 inches (164 cm). The patient had no family medical history. There were no concomitant medications. No additional vaccines administered on same date of pfizer suspect and no prior vaccinations within 4 weeks. No adverse events follow prior vaccinations. The patient experienced multiple side effects 10 hours after the vaccine and lasted 20 hours. Side effects started 20:00 - 21:00 on 30Dec2020. Side effects were classified as: Nausea, migraine headache, chills, and joint pain. The events was waxing and waning. On 31Dec2020, side effects were 75% gone by 16:00. Joint pain was completely going by 22:00-23:00 on 31Dec2020. Chills were gone between 08:00-09:00 on 31Dec2020. Nausea and migraine headache stayed until 16:00-17:00 on 31Dec2020 and then it went away. At the time of vaccination, there was a low-pressure center coming through. There was also an ice and snowstorm. She was wondering if the headaches and joint pain were due to the weather. The patient took no medication or treatment for spondylolisthesis and wondered if that had something to do with it. The patient really want to have second shot in two weeks. Investigation assessment was no. The outcome of the events was recovered on 31Dec2020. Causality assessment by primary reporter via global introspection was unknown.
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| 59 | 2021-01-07 | difficulty swallowing |
Patient developed dry mouth and dificulty swallowing 11 min after vaccination, lasted 30 min. Has li...
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Patient developed dry mouth and dificulty swallowing 11 min after vaccination, lasted 30 min. Has lingering post nasal drainage.
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| 59 | 2021-01-07 | decreased appetite, nausea |
This 59 yo contractor was referred to for HA, dizziness and nausea after her first COVID vaccine. S...
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This 59 yo contractor was referred to for HA, dizziness and nausea after her first COVID vaccine. She received Pfizer COVID vaccine on 12/31/2020. She advised 8 hours later she developed a severe headache. She advised she took 800 mg Ibuprofen and 4 hours later took 1000mg Tylenol and was able to go to sleep. She awoke the next day with her headache persisting and was nauseated. She stated she would alternate Ibuprofen and Tylenol every 4 hours and drink gatorade/water (appetite was low and didn't eat). She denied any fever, rash, SOB, arthralgia, myalgia or other systemic symptoms. Day 4 post vaccination (1/4/2021) she cut med use down to every 8 hours. She stated use of Ibuprofen/Tylenol did resolve
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| 59 | 2021-01-07 | nausea |
Upon awakening, exhausted feeling, severe weakness, total body aches, chills, temp 97.4 orally, slig...
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Upon awakening, exhausted feeling, severe weakness, total body aches, chills, temp 97.4 orally, slight nausea. Notified supervisor at work, took Tylenol 1000 mg and slept for 2.5 hours. Woke up with symptoms much reduced and went to work
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| 59 | 2021-01-07 | nausea |
Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left ar...
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Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left arm a little itchy. Took Benadryl , slept and then felt better. Did fine with first shot.
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| 59 | 2021-01-08 | abdominal pain |
First vaccine injection 12/19/2020. Symptom of fatigue. Second vaccine injection 01/07/2021: Abou...
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First vaccine injection 12/19/2020. Symptom of fatigue. Second vaccine injection 01/07/2021: About 3 hours after receiving the 2nd injection, I had terrible headache requiring dosages of OTC Tylenol, terrible abdominal pain/pressure similar to menstral cramping, extreme fatigue requiring prolonged sleep, nightmares (which I never have). All symptoms lasted for approximately 38 hrs.
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| 59 | 2021-01-10 | vomiting |
06:fever, body aches, Headaches, soreness-left arm-99.7-T 07th:& 8th: Headaches & fever-more than t...
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06:fever, body aches, Headaches, soreness-left arm-99.7-T 07th:& 8th: Headaches & fever-more than the 6th, 99.9-T Sat the 9th vomiting 2 times---she took Tylenol 325mg times 2 for her fever-T-99.7 Sunday the 10th vomited 10 times-99.9 T This Am the 11th of January@0100-cramping--------99.1 T
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| 59 | 2021-01-10 | diarrhea | Cough. Runny nose. Headache. Diarrhea |
| 59 | 2021-01-10 | nausea |
Patient experienced right eyelid and cheekbone numbness following the first dose. She received her s...
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Patient experienced right eyelid and cheekbone numbness following the first dose. She received her second dose 11 days after the first in error. Following the second dose, she reported cheek numbness and nausea, which had resolved when I spoke with her on 1/11/21.
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| 59 | 2021-01-10 | nausea |
Patient received the first dose of the COVID vaccine on 12/28/20, and the second dose on 1/8/21 (11 ...
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Patient received the first dose of the COVID vaccine on 12/28/20, and the second dose on 1/8/21 (11 days later instead of 21 days). The patient reported experiencing right eyelid and cheekbone numbness and a minor headache after the first dose. She had numbness to her right cheek again on 1/8/21 and some nausea that has resolved. I spoke with the patient on 1/11/21 and she is feeling well.
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| 59 | 2021-01-10 | nausea | Rash entire body, throat swelling, extreme nausea. |
| 59 | 2021-01-10 | decreased appetite |
She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsen...
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She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened; From the time she got the vaccine to now, she has lost 20 lbs; shake/shaking; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; She has been sick since Wednesday; itching all over from head to toe; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 30Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension and allergic to ace inhibitors. There were no concomitant medications. Patient was calling about the Covid Vaccine. She was having an allergic reaction. She did not know what to do to stop it. She went to the ER yesterday (04Jan2021). She had been sick since Wednesday (30Dec2020), she was itching all over from head to toe since 30Dec2020, she got a prescription for Prednisone, she took 2 doses yesterday, 1 dose today, and would take another this evening. She took Benadryl, an hour ago and had an episode, and so she had to jump in the shower and let the cold water run to stop itching, the itching did not stop but it has minimized. She put Benadryl gel and she was still itching, she had taken enough Benadryl. Patient asked what is the best way and if she needed an IV of something, she went to ER on Sunday, she was not seen by doctor, it was a nurse practitioner, she didn't do anything but just listen to her and she only looked at ankles to check for swelling. Patient stated that she had been drinking water and urinating, she had no appetite and lost 20 lbs. Patient confirmed that she got her first dose of the Covid vaccine on 30Dec2020 at 1 o clock, the itching started the same day at 5 o clock, the itching was from head to toe. She experienced swelling in the lips, throat, and eye lids, which started 02Jan2021. She began losing her appetite on 30Dec2020. From the time she got the vaccine to now (05Jan2021), she has lost 20 lbs. An hour ago (05Jan2020) she had an episode, which made her shake, and she did not have the shakes before, this was the first date she started shaking. Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened. Her 2nd dose was scheduled in 21 Days. However, she may not get the second dose, patient stated that she could not get through this no more. She had no positive test for Covid prior to vaccine. She had no antibody test prior to the vaccine. She had not any issues with vaccines in the past. Patient stated that if she was still feeling this way, she would go to a different hospital. When she went to the ER, she was not hospitalized, they sent her back home the same day. Patient would like to know if there was anything that can remove the vaccine from the body. The outcome of the events itching all over from head to toe, loss of appetite, swelling in the lips, throat, and eye lids was not recovered, of the other events was unknown. Information about lot/batch number has been requested.
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| 59 | 2021-01-10 | abdominal discomfort | Upset stomach |
| 59 | 2021-01-10 | nausea | nausea in the head, fatigue, muscle soreness-resolved |
| 59 | 2021-01-11 | nausea | Body aches, Headache, Nausea |
| 59 | 2021-01-11 | nausea | developed body aches and nausea |
| 59 | 2021-01-12 | decreased appetite |
1/8/20201 2:30am lightheaded, chills 101 3:30am fingers/toes like ice had tylenol 7:30am felt beter...
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1/8/20201 2:30am lightheaded, chills 101 3:30am fingers/toes like ice had tylenol 7:30am felt beter 5:30pm Shivering muscle pain temp 101 took motrin 1/9/2021 Felt 80% ok 1/10/2021 and 1/11/2021 95% better Appetite decreased from 1/8/20201-1/11/20201 ( dry mouth, fever, chills, lightheadedness, muscle pain)
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| 59 | 2021-01-12 | nausea | Fatigue. Injection site pain. Chills. Body aches, headache, nausea. Resolved. |
| 59 | 2021-01-12 | diarrhea |
Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a ...
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Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a check up with my doctor with no symptoms.. Injection on left high upper arm redness around . Muscles pain and tremors of my hands , tired Diarrhea for two days and sweats.
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| 59 | 2021-01-12 | diarrhea, nausea, vomiting |
Went to bed not feeling well. My husband came to check on me approx. 12:30 am. He was unable to arou...
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Went to bed not feeling well. My husband came to check on me approx. 12:30 am. He was unable to arouse me. When he tried to get me up out of bed I collapsed and then had syncopal episode. He call 911. Paramedics could not get blood pressure and I was diaphoretic and body temp was cold. They rushed me to the hospital. My blood pressure was dangerously low along with my body temperature. I was given epinephrine and LEVOPHED to get a blood pressure. I was warmed up. Then I had GI issues of vomiting, diarrhea, nausea. I spend 4 days in hospital.
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| 59 | 2021-01-13 | abdominal pain, nausea |
1/12/21 around 10:00 reports having nausea, abdominal cramping, weakness, and uncontrolled shaking o...
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1/12/21 around 10:00 reports having nausea, abdominal cramping, weakness, and uncontrolled shaking of hands, chills and present at this time 1/14/21
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| 59 | 2021-01-13 | nausea |
About 10-20 minutes after receiving the vaccine, patient she started having a sensation of tongue s...
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About 10-20 minutes after receiving the vaccine, patient she started having a sensation of tongue swelling. Patient was treated with an IM injection of epinephrine and then transported down to the emergency department. Upon arrival to the ED, she felt markedly improved with no symptoms other than some mild nausea. Patient was treated with steroids and ondansetron.
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| 59 | 2021-01-13 | nausea |
Nausea; fatigue; muscle aches; chills; transient SOB; runny nose; weird headaches or fullness; This ...
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Nausea; fatigue; muscle aches; chills; transient SOB; runny nose; weird headaches or fullness; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), intramuscularly on 22Dec2020 at 15:00 on Left arm at single dose for COVID-19 immunization. The patient medical history included known allergies with Chloreseptic spray. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included ergocalciferol (VIT D); ascorbic acid (VIT C); probiotics (reported as probiotic); alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME); trazodone (reported as trazadone) for sleep; fluticasone. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Nausea, fatigue, muscle aches, chills, transient SOB (Shortness of breath), and runny nose, weird headaches or fullness on 22Dec2020 at 19:00. Since the vaccination, patient had been tested for COVID-19 via Nasal Swab on 04Jan2021, result: Negative. No treatment was received for the events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
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| 59 | 2021-01-14 | difficulty swallowing |
About 2 min after receiving injection, I felt an intense flushing feeling all over, it felt as if my...
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About 2 min after receiving injection, I felt an intense flushing feeling all over, it felt as if my blood had turned into lava. About a minute after that I felt a "tickle" in my throat. The same sensation I felt when I had my reaction to Gadolinium. I tried to swallow, and it was a little difficult. I did NOT feel short of breath. I tried to calm down by doing slow concentrated breathing. I continued to take small sips of water to gauge my swallowing ability. After about 2-3 minutes, the flushing sensation subsided, and swallowing started to improve. I had brought my Epinephrine pen with me. About 1-2 min after the flushing sensation had subsided,, it came back and my swallowing ability got much worse, to the point I couldn't swallow a small sip. I was breathing well, and did NOT feel short of breath, but gave myself my Epinephrine injection at that time. A Rapid Response was called at that time, my vitals signs taken, an IV inserted, 911 called. O2 sats were fine mid 90's, heart rate was mid 80's, BP was elevated, I don't remember the exact systolic 170-180, but my diastolic was 116. It took the ambulance approximately 10-15 min to arrive. By the time the ambulance arrived, I was feeling close to my baseline and my BP was improving. I was seen by the ER MD, and feeling fairly well, my throat still felt a tiny bit tight, but no difficulties swallowing. The plan was to complete treatment with IV steroids, Benadryl, and Pepcid, then be observed for a few more hours. This was approximately around 16:30. Not more than 5 min after MD left my room, I got the flushing feeling, and throat closing feeling again. While the medications were being prepared these symptoms increased, ( I could still breath adequately and vital signs were still OK. It took about 10 minutes after meds were given for symptoms to begin to subside ( No epi given) I was observed until 21:30 then discharged. I am taking 50 mg daily x 3 days, 25mg Benadryl q 8hrs x 3 days, and 20mg Pepcid bid x 3 days. I feel fine , no further episodes
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| 59 | 2021-01-14 | nausea |
At 09:30 am patient complaints of H/A, nausea, SOB and cough. Vitals signs BP 159/103 mmHg, HR 79 bp...
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At 09:30 am patient complaints of H/A, nausea, SOB and cough. Vitals signs BP 159/103 mmHg, HR 79 bpm and O2sat 100%. A rapid response code for an anaphylactic reaction was activated at 9:35am. Patient was transferred to the ER vital signs were BP 173/123mmHg , HR 106 bpm, Dxt 93 and O2sat 94%. One dose of Epinephrine 0.3mg IM, D5W 20g/250ml IV, Benadryl 50mg IV and Solu-Cortef 200mg IV were administrated.
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| 59 | 2021-01-14 | diarrhea |
Diarrhea, chills on 1/12/21 - 1/14/21. Symptoms have stopped. On injection site there is a half doll...
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Diarrhea, chills on 1/12/21 - 1/14/21. Symptoms have stopped. On injection site there is a half dollar size red area which is hot to the touch with hardness or a knot at injection site. tHIS IS STILL PRESENT.
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| 59 | 2021-01-14 | diarrhea |
Diarrhea; severe chills; sore arm; This is a spontaneous report from a contactable other healthcare ...
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Diarrhea; severe chills; sore arm; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) then received the second dose (lot number: EK 9231, expiration date: not reported) on 08Jan2021 13:45 both via an unspecified route of administration on the left arm at a single dose for COVID-19 immunization. Medical history included that the patient had allergies to medications, food, or other products such as Penicillin, Sulfa drug and pork. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), ascorbic acid (VIT C), ergocalciferol (VIT D) and biotin (BIOTIN). On 08Jan2021 22:45, 9 hours after vaccine the patient experienced diarrhea, severe chills and sore arm. As treatment, patient received ibuprofen (ADVIL) and fluids. The outcome of the events was recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number (first dose) has been requested.
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| 59 | 2021-01-14 | nausea |
I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had ...
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I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had taken one 325mg Tylenol and one 200mg Ibuprofen approximately 60 minutes prior to receiving vaccine (which is what I did prior to the first vaccine). I was doing great initially following the vaccine. I took another 325mg Tylenol and 200mg Ibuprofen when I went to bed at 2000 1-12-21. At 0300 1-13-21 I woke up feeling nauseated and when attempting to turn over to my right side I moaned loudly because I could not hardly move my left arm. My husband was woken and turned on the bedroom light and we noted a 3 inch bruise and large knot on my left deltoid at the injection site. He told me that I felt warm. I took my temperature that was 101.2 degrees. I took 650mg Tylenol and that time. At 0500 1-13-21 I was having chills, muscle and joint aches. I could not fully close my hands into a grip. My "brain" hurt, not a headache but literally it hurt to move my head. I would occasionally get a sharp pain in the front and back of my head. My temperature went to its highest at approximately 1500 1-13-21 to 102.5 degrees. I continued to offset Tylenol with Ibuprofen throughout the day. At 2000 1-13-21 my temperature was 101.8 and began to trend downward. I went to bed and when I woke up on 1-14-21 I felt 100% better with just a little fatigue from the inability to sleep the day prior.
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| 59 | 2021-01-14 | nausea, decreased appetite |
On 1/8 she took her 2nd dose of Pfizer vaccine around 3 PM. She went home in the evening and started...
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On 1/8 she took her 2nd dose of Pfizer vaccine around 3 PM. She went home in the evening and started sweating. She passed out. Her daughter was at home and she took her to the nearest hospital. Her BP was 60/34 and she had a temp of 100.3F on 1/8 during hospital admission. Her K was low. She received lot of fluids. She called our office on 1/10 and during the f/u she was still in the hospital. On 1/10 she has a temp of 98.4F and BP of 109/61. But she still has dizziness, nausea, anorexia and mild cough (Former smoker). COVID-19 test was done on 1/9, its negative. Dx was dehydration. Discharged from the hospital on 1/11, feels better but is tired. Will follow up with PCP on 1/16/21.
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| 59 | 2021-01-14 | nausea |
Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Resi...
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Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Residents blood pressure was elevated as well and she complained of nausea. Resident was fine this morning and the past several days with no complaints. This resident has a history of muscle spasms and tremors as well as some catatonic states in the past.
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| 59 | 2021-01-17 | nausea | Became hot and nauseated |
| 59 | 2021-01-17 | vomiting, nausea |
On 01/13/2021 at about 11pm I began having pain in both arms and across my chest. Also nausea and vo...
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On 01/13/2021 at about 11pm I began having pain in both arms and across my chest. Also nausea and vomiting. At midnight I went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement. I had complete occlusion of the right coronary artery
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| 59 | 2021-01-17 | nausea |
Premedicated with Ibuprofen 400mg about 2 hours before injection yesterday. Woke up this morning w...
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Premedicated with Ibuprofen 400mg about 2 hours before injection yesterday. Woke up this morning with chills, low grade fever, mild nausea, a headache, and a very sore arm. By late morning I had a fever of 100.9 and a severe headache. Early afternoon fever went up to 102.1. At this time I took ibuprofen 400mg and sumaptriptan 100mg. Fever came down and heaeache lessened.
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| 59 | 2021-01-17 | diarrhea, vomiting, nausea | fever ( 101.7); sever headache, neck pain, nausea/vomiting, diarrhea, rib,spine, hip pain |
| 59 | 2021-01-18 | nausea, abdominal pain upper |
Difficulty breathing, high blood pressure and heart rate. Very sick for the next 3 days...bedridden...
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Difficulty breathing, high blood pressure and heart rate. Very sick for the next 3 days...bedridden due to sickness; nausea, shaking, weakness, muscle aches, joint aches, severe headache, stomach pain, skin blisters, fever and chills, injection site pain, tiredness, dizziness. By the 4th day I am still weak and now I have skin blisters on my body in various places. Today is the 5th day and I still feel weak and slightly sick, nausea and fatigue and more skin blisters, fever.
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| 59 | 2021-01-18 | decreased appetite, nausea |
Pt had nausea after 2 hours and felt tired/heavy feeling. Took Ibuprofen. On day later, experien...
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Pt had nausea after 2 hours and felt tired/heavy feeling. Took Ibuprofen. On day later, experienced more nausea and lack of appetite, and then had a terrible headache. It got worse and she experienced neck stiffness and her blood pressure was 175/95 at 4pm on 1/8. She rested and felt better about 24 hours later. She felt normal again after a few days.
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| 59 | 2021-01-19 | nausea |
Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy ...
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Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy head" feeling. Hypertensive at time BP left arm 171/95 HR 79, RR 26, 99% RA. Apple juice, and cracker provided, and emesis bag provided. Patient was already waiting for thirty minutes time (she was 15 minutes into her wait time). She reported having a progression of nausea and dizziness Repeat vital signs at 1345 139/100 HR 76, RR 24 Pox 96% RA. First responder was called and patient was assisted into wheelchair and taken to the ER for further evaluation.
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| 59 | 2021-01-19 | difficulty swallowing |
Within 1-2 days after COVID vaccine developed dysphagia and vise-like chest pain within a few second...
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Within 1-2 days after COVID vaccine developed dysphagia and vise-like chest pain within a few seconds of swallowing.
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| 59 | 2021-01-20 | nausea |
Body shaking; Chills; Tingling; Nauseous; Body ache; Tiredness; having like little sweat; This is a ...
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Body shaking; Chills; Tingling; Nauseous; Body ache; Tiredness; having like little sweat; This is a spontaneous report from a contactable nurse (reporting for herself). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration from 08Jan2021 07:40 at single dose for COVID-19 immunization. Medical history included hypertension, high cholesterol and COVID-19 survivor from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had historical vaccine of first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient stated, "I am calling to report a side effect from the vaccine (Clarified COVID-19 vaccine). I am a health care worker, I got the first dose I was fine but I got the second dose last Friday and I woke up hour later with terrible chills, tingling, my body shaking. It was not half an hour later, it was hours later. I took it at 07:40 in the morning at work and then I came home, I was fine but then chills woke me up in mid night Friday it was Saturday, let's say Saturday morning 12 am. I woke up with chills like, I am in refrigerator and I felt like I wanted to warm it but I did not, I felt nauseous, it happened like two different times and after that I took like Motrin (treatment) I did not have any temperature but I have like body ache and after that I started having like little sweat and tiredness. I just call my job now. Having the same symptoms now." The patient took Motrin and Tylenol and underwent lab work at the hospital with unknown result. The patient think that the events were related to COVID as the patient stated, "I think so because I woke up with the chills extreme chills. I never felt that way, it's like the last time when I felt it, when I had COVID, I woke up with extreme chills the only difference between this one was that I didn't have a temperature with these chills but with COVID I have temperature but this one was extreme chills." The outcome of the events was unknown.
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| 59 | 2021-01-20 | abdominal pain upper, abdominal discomfort |
Extreme fatigue, I even had to take days off where I sat in the dark in my living room unable to do ...
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Extreme fatigue, I even had to take days off where I sat in the dark in my living room unable to do anything due to lack of energy. The week of the vaccine I had to go 3 days early due to the exhaustion. I also had stomach pain and bowel issues. I went to the clinic and the first time they thought it was diverticulitis and the second time they ordered a CT scan of the abdomen and some labs and they all came normal.
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| 59 | 2021-01-20 | nausea | Pain at injection site Arm, shoulder, neck pain Headache Fatigue Chills Nausea |
| 59 | 2021-01-20 | indigestion |
severe heartburn; Soreness at injection site; Fatigue; Fever up to 101.8; achenes and weakness; ache...
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severe heartburn; Soreness at injection site; Fatigue; Fever up to 101.8; achenes and weakness; achenes and weakness; first dose of BNT162B2 on 20Dec2020/second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 59-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) intramuscular at left arm on 06Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included diabetes and hypertension. no allergies to medications, food, or other products. other medications in two weeks included hydrochlorothiazide, lisinopril, atorvastatin, metformin and colecalciferol (D3) and fish oil, tocopherol (OMEGA 3 [FISH OIL;TOCOPHEROL]). the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took first dose of BNT162B2 (brand=Pfizer, Lot number: EJ1685) on 20Dec2020 04:00 PM via intramuscular at left arm at single dose for COVID-19 immunization (59 years old) and had muscle soreness at greater injection site. Patient experienced soreness at injection site, Fatigue, Fever up to 101.8, severe heartburn, achenes and weakness, all on 07Jan202101:00 AM. Prior to vaccination, the patient was not diagnosed with COVID19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect.
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| 59 | 2021-01-21 | vomiting |
12/22 vaccination 12/23 8-10PM fever, feeling poorly, and vomiting thereafter. Rotated between the ...
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12/22 vaccination 12/23 8-10PM fever, feeling poorly, and vomiting thereafter. Rotated between the tylenol and motrin. Vomiting 1 episode. Fever 24-48 hours after vaccination. 2 days poorly.
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| 59 | 2021-01-21 | abdominal distension |
Fever, chills , body aches, for 24 hours. Fever finally broke after soaking 2 sets of pjs. Back ach...
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Fever, chills , body aches, for 24 hours. Fever finally broke after soaking 2 sets of pjs. Back ache. Sore arm. I've recovered from all of that with tylenol. but I have swelling and tenderness under the arm, lymph nodes?
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| 59 | 2021-01-21 | nausea |
Starting around 11:30am the day after my vaccine I started to get chilled. As the afternoon progres...
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Starting around 11:30am the day after my vaccine I started to get chilled. As the afternoon progressed the chills became stronger and I felt nauseous and had body aches. I left work 1/2 hour early. I woke up the next day with the same symptoms but the nausea and body aches were worse and now my kidneys were tender. I went to work but continued to feel worse. I left work early that day and went straight to bed. I woke up the next day feeling so much better.
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| 59 | 2021-01-21 | vomiting |
Systemic: Anaphylaxis-Medium, Systemic: Chills-Severe, Systemic: Generalized Body Aches -Medium, Sys...
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Systemic: Anaphylaxis-Medium, Systemic: Chills-Severe, Systemic: Generalized Body Aches -Medium, Systemic: Headache-Severe, Systemic: Vomiting-Mild
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| 59 | 2021-01-23 | nausea |
1/21 at 10:45PM-joint/muscle pain & bad chills. 1/22 all day--headache, nausea, slept alot. 1/24--ve...
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1/21 at 10:45PM-joint/muscle pain & bad chills. 1/22 all day--headache, nausea, slept alot. 1/24--very sleepy; bad balance--small steps and holding wall/furniture; lips swollen; slow cognition
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| 59 | 2021-01-23 | nausea, diarrhea |
10 pm started with uncontrollable chills and headache about 5 am fever body ache nauseated Next day...
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10 pm started with uncontrollable chills and headache about 5 am fever body ache nauseated Next day sat 1/9 2pm diarhea lasted 24 hours Monday fatigue headache and body ache continued Tues headache fatigued and short of breathe wed woke up with sl headache and weak by dinner time felt better
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| 59 | 2021-01-24 | abdominal pain | 12/18/20 abdominal pain, resembling gas pain, severe, lasted about two minutes |
| 59 | 2021-01-24 | nausea |
First day:chills, sore throat, nausea, fatigue, H/A starting about 2 pm Second day: fatigue, less na...
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First day:chills, sore throat, nausea, fatigue, H/A starting about 2 pm Second day: fatigue, less nausea, chills, H/A Third day: Extreme fatigue and Fever 100.9 oral
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| 59 | 2021-01-24 | diarrhea, abdominal pain upper |
Less than 24 hours after vaccine started stomach cramps, diarrhea and sore arm, next day ocular migr...
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Less than 24 hours after vaccine started stomach cramps, diarrhea and sore arm, next day ocular migraine(never had before) with flashing lights and severe headache, extreme fatigue, sore throat, felt terrible Had vaccine on Friday and by Monday, I felt recovered
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| 59 | 2021-01-24 | abdominal pain upper |
Patient submitted MyChart message as below detailing her adverse reaction to COVID-19 vaccine: "Hell...
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Patient submitted MyChart message as below detailing her adverse reaction to COVID-19 vaccine: "Hello, I received my first Pfizer COVID vaccine on Friday Jan 22 at a health care program. On Friday I felt no arm discomfort, but had a stomach ache all day. Saturday I was very tired and in the evening I noticed my left shot shoulder/arm pit area, bra line area was swollen and uncomfortable. Woke up in the night feeling like my left arm pit, and breast area was more swollen and if I had to paint it I would describe it as tiny bubbles all enlarged underneath my skin. Guessing it is my lymph nodes? This unusual feeling has since spread to the left side of my neck inside my throat and out. It is not painful, I have taken a warm shower, only wearing loose, comfy clothing and am sitting with a warm bean pillow on my neck. I just wanted to report how I am feeling if others are having similar reactions."
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| 59 | 2021-01-24 | abdominal pain | Severe abdominal pain, resembling gas pain, intermittent over two minutes |
| 59 | 2021-01-24 | indigestion, diarrhea |
soreness at injection site x 2 days, bruising, and edema at site of injection x ~ 1 week, Diarrhea ...
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soreness at injection site x 2 days, bruising, and edema at site of injection x ~ 1 week, Diarrhea x 5-8 days, colon pain/inflammation x 3-4 days, indigestion/chest heaviness continue til yesterday not as bad worse the first 3 to 8 days, now briefly during day
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| 59 | 2021-01-25 | nausea, diarrhea, abdominal discomfort |
I just could not stay out of the bathroom for long, I just kept coming in and cleaning out my gut; M...
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I just could not stay out of the bathroom for long, I just kept coming in and cleaning out my gut; My tummy started to feel a little bit strange, queasy and all that; My tummy started to feel a little bit strange, queasy and all that; This is a spontaneous report from a contactable consumer reported for self. This 59 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jan2021 at single dose (Lot: EJ1685, Expiration Date: Mar2021) for covid-19 immunisation. Medical history included High Blood Pressure, Severe Asthma. The patient stated weighed a little less before the holidays. The patient 169 pounds and now it is 10 pounds more than weighed before the holidays (general statement). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 for covid-19 immunisation. Concomitant drug included amlodipine for high blood pressure, losartan at 100 mg for high blood pressure, milrinone (PRIMACOR) and montelukast sodium (SINGULAIR) for asthma. The patient stated, "I got the second vaccine this Saturday and then yesterday, Sunday (10Jan2021), my tummy started to feel a little bit strange, queasy and all that and then tonight, last night (11Jan2021), when I went to work, I just could not stay out of the bathroom for long, I just kept coming in and cleaning out my gut and I did not really eat that much yesterday, so, I don't think it was anything I ate. I just wanted to report that I had stomach issue and that was a result to the vaccine." The patient had some Imodium but was wondering if should take it. Outcome of the events was unknown.
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| 59 | 2021-01-25 | nausea |
Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint ...
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Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint pain; Cough; feeling of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 09Jan2021 11:00 at single dose for Covid-19 immunization. Medical history included asthma and hypertension. The patient received an unspecified medication in two weeks. The patient previously took codeine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pulsating headaches, blurry vision, nausea, 102.2 fever, body aches, hand tremors, dizziness, joint pain, cough, and feeling of exhaustion on 09Jan2021 (12:00 PM). There was no treatment received for the events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
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| 59 | 2021-01-25 | nausea, diarrhea |
ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/hea...
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ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/heavy chest; bad head cold/heavy duty cold; stuffy nose; headache; Swollen glands; Sore throat; Chills; Nausea; Runny nose; This is a spontaneous report from a 'contactable consumer and a physician. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EJT685, expiry date not reported) intramuscular in the left arm on 19Dec2020 at single dose for COVID-19 immunisation. On 11Jan2021, the patient felt tired/very fatigued, had body aches, chest heaviness/heavy chest, bad head cold/heavy duty cold, stuffy nose, headache, swollen glands, sore throat, chills, nausea, runny nose, ears are plugged, and diarrhea. On 12Jan2020, the patient experienced cough and stuffy head. Therapeutic measures were taken as a result of bad head cold. Clinical outcome of the events was unknown.
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| 59 | 2021-01-26 | nausea |
1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20...
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1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20 and 1/21. 01/22/21 awakened at 4am with "head itching", dizzy, headache, numbness in arms, nausea. In the evening hives started on hands/back/legs. 01/23/21 Went to Urgent Care because hands "felt like I had them on a hot plate, burning".
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| 59 | 2021-01-26 | diarrhea, nausea |
Headache, left hand numbness, injection site inflammation and pain to right elbow, right scapula pai...
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Headache, left hand numbness, injection site inflammation and pain to right elbow, right scapula pain, diarrhea x2, nausea,
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| 59 | 2021-01-26 | abdominal pain upper, nausea | Nausea, stomach cramps, fatigue, and weakness |
| 59 | 2021-01-26 | nausea, abdominal pain upper | nause, stomach cramps, fever blisters, lethargic, weakness |
| 59 | 2021-01-26 | nausea |
severe arthralgias; migraine headache; mild nausea; This is a spontaneous report from a contactable ...
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severe arthralgias; migraine headache; mild nausea; This is a spontaneous report from a contactable nurse. A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142/expiration date unknown) dose number 2, via an unspecified route of administration on 08Jan2021 09:00 at a single dose on the right arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included asthma, arrhythmia, sulfonamide allergy, and latex allergy. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. Historical vaccine included BNT162B2 (COVID-19, lot number EJ1685, dose number 1) on 18Dec2020 06:30 on the right arm. There were no other vaccinations within 4 weeks. Concomitant medications included ASA, acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN), cyanocobalamin (VIT B12), ergocalciferol (VIT D), and cetirizine hydrochloride (ZYRTEK). The patient experienced severe arthralgias, migraine headache, and mild nausea on 08Jan2021 20:00. The outcome of the events was recovered in Jan2021.
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| 59 | 2021-01-27 | abdominal pain, vomiting |
Patient with inoperable pancreatic cancer received second Pfizer vaccine approximately 12:30 pm on 1...
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Patient with inoperable pancreatic cancer received second Pfizer vaccine approximately 12:30 pm on 1/27/21. At approximataely 16:30, patient complained of abdominal pain and was given Levsin 0.125mg and morphine 5mg orally. At approximately 19:30 patient was found on the floor covered in a large amount of emesis, unresponsive without a pulse.
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| 59 | 2021-01-28 | decreased appetite |
Dehydration, fever 101, body aches, joint pain, chills, loss of appetite, increased fatigue, headach...
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Dehydration, fever 101, body aches, joint pain, chills, loss of appetite, increased fatigue, headache, heightened smell, taste, and hearing
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| 59 | 2021-01-28 | vomiting | Fever, vomiting, body aches |
| 59 | 2021-01-29 | nausea |
Nausea, heaviness in my chest, then difficulty breathing within 10-12 minutes following second dos...
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Nausea, heaviness in my chest, then difficulty breathing within 10-12 minutes following second dose administration into Right arm at 16:59. I took my albuterol inhaler, which did very little, so i added 20 mg prednisone tablet that i carry with me for emergency. Benadryl/Aleve mix (2 Aleve pm) taken at bedtime to assist in sleep and reaction. By 7:30 am i could not breath, peak flow meter revealed reduction to 68% capacity, so I took 60 mg prednisone, continued with albuterol inhaler q 4 hours,as i did the evening before. Then added Montelekust and allegra (antihistamine). Fever reached 99.4 degrees Fahrenheit, taken Temporal method- high for me, as i run low. An hour later, elevated temp to 100.5, same method, and has remained throughout the day and evening.
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| 59 | 2021-01-30 | diarrhea, vomiting |
Headache, fever up to 102, chills, major diarrhea, vomiting. I lost 3 lbs. Tested negative with the...
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Headache, fever up to 102, chills, major diarrhea, vomiting. I lost 3 lbs. Tested negative with the rapid COVID test.
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| 59 | 2021-01-31 | nausea | Nausea, Body aches |
| 59 | 2021-01-31 | nausea |
red rash; bruise; slight nausea; slight feeling of fever but temp registered normal; This is a spont...
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red rash; bruise; slight nausea; slight feeling of fever but temp registered normal; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number BNT162b2), at age of 59-year-old via an unspecified route of administration in left arm on 31Dec2020 11:00 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID), valsartan, rosuvastatin (ROSUVASTATIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient was not pregnant at Time of Vaccination. The patient experienced red rash, bruise, slight nausea, slight feeling of fever but temp registered normal on 12Jan2021 01:00 with outcome of recovering. The patient received topical antibiotic, diphenhydramine (BENADRYL) for treatment. The events resulted in doctor or other healthcare professional office/clinic visit.
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| 59 | 2021-02-02 | vomiting, nausea |
45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilati...
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45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilating, increased B/P 200+/130+, decreased Responsiveness, tunnel vision, pin point pupils and no response to verbal and tactile cues For about 10 minutes. Transported to Hospital. Have Residual HTN.
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| 59 | 2021-02-03 | nausea |
Severe nausea & dizziness the night after the vaccine was administered and throughout the following ...
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Severe nausea & dizziness the night after the vaccine was administered and throughout the following day. Subsided within 72 hrs.
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| 59 | 2021-02-03 | abdominal discomfort |
lightheadedness; Fever 100.2; body aches; Headache; Upset stomach; This is a spontaneous report from...
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lightheadedness; Fever 100.2; body aches; Headache; Upset stomach; This is a spontaneous report from a contactable other health professional (patient). A 59-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL1284), in a hospital intramuscularly on 13Jan2021 at 09:45 at 59-years-old at a single dose for COVID-19 immunization. Medical history included sarcoidosis from 2006 to an unknown date, breast cancer from 2006 to an unknown date, depression from an unknown date and unknown if ongoing, migraines from an unknown date and unknown if ongoing, reflux from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing. Concomitant medications included krill oil (MANUFACTURER UNKNOWN), colecalciferol (D3), zinc (MANUFACTURER UNKNOWN), chondroitin sulfate, glucosamine sulfate (MANUFACTURER UNKNOWN), gemfibrozil (MANUFACTURER UNKNOWN) , omeprazol [omeprazole] (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), almotriptan malate (MANUFACTURER UNKNOWN), acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), albuterol [salbutamol] (MANUFACTURER UNKNOWN), prednisone (MANUFACTURER UNKNOWN), senior vitamin (MANUFACTURER UNKNOWN), "tension migraine" (MANUFACTURER UNKNOWN), all taken for an unspecified indication from an unspecified date to an unspecified date; "meticore" (MANUFACTURER UNKNOWN) taken for weight loss from an unspecified date to an unspecified date . The patient previously took nystatin (MANUFACTURER UNKNOWN), cefalexin (KEFLEX), hydrocodone bitartrate paracetamol (VICODIN), LEVOFLOXACIN (LEVAQUIN) and experienced drug allergy from an unspecified date to an unspecified date. The patient previously received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; first dose at 10:00, intramuscularly in the right arm-Lot Number EL1284) for COVID-19 immunization on 22Dec2020 at 59-years-old. On 16Jan2021 at 11:15, the patient experienced: lightheadedness, fever 100.2, body aches, headache, upset stomach. There was no treatment received. The patient underwent lab tests and procedures which included body temperature: 100.2 on 16Jan2021. The clinical outcome of the events was recovered in Jan2021. The patient did not receive another vaccine within four weeks of the bnt162b2. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.
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| 59 | 2021-02-04 | vomiting, diarrhea, nausea |
Sore at injection site; Severe nausea; vomiting; diarrhea starting 6 hours after injection; This is ...
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Sore at injection site; Severe nausea; vomiting; diarrhea starting 6 hours after injection; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Pfizer brand; lot number: Ek3246), via an unspecified route of administration on 13Jan2021 10:15 on left arm at a single dose for COVID-19 immunization. Medical history included psoriasis, lymphocytic colitis and allergies to pistachios (anaphylaxis). The patient's concomitant medications were not reported. The patient experienced sore at injection site, severe nausea, vomiting and diarrhea starting 6 hours after injection (pending clarification); all on 13Jan2021 14:30 (as reported). Then the same symptoms starting 22Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The report was non-serious. The outcome of the events was recovered with sequelae.
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| 59 | 2021-02-04 | nausea |
Symptoms started a few hours after vaccination. Initial symptoms were injection site pain and tired...
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Symptoms started a few hours after vaccination. Initial symptoms were injection site pain and tiredness. I later developed a mild headache, moderate muscle and joint pain, to which I applied a heating pad. I then developed a low fever and chills. Temp was 99.7 11:30pm on Feb 4, and 99.9 at 10:20 on Feb 5. I then began to feel nauseous and generally terrible, so I went to the bathroom, where I fell and may have passed out.
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| 59 | 2021-02-04 | abdominal pain upper |
severe generalized burning pain, tachycardia, elevated blood pressure, dizziness, chest pain, stomac...
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severe generalized burning pain, tachycardia, elevated blood pressure, dizziness, chest pain, stomach pain, headache daily starting on 01/06/2021 to 01/27/2021; moderate generalized burning pain, tachycardia, elevated blood pressure 1/27/2021 to now; daily use Cymbalta for neuropathy pain; Amlodipine for high blood pressure; undergoing cardiology evaluation, continuing neurology visits; pending endocrinology evaluation
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| 59 | 2021-02-05 | nausea |
PATIENT WAS OUT OF WORK DUE TO RACTION TO THE SECOND COVID VACCINE. SYMPTOMS WERE BODY ACHES, NAUSEA...
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PATIENT WAS OUT OF WORK DUE TO RACTION TO THE SECOND COVID VACCINE. SYMPTOMS WERE BODY ACHES, NAUSEA AND EYES BURNING.
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| 59 | 2021-02-06 | nausea, diarrhea | Extreme headache, nausea, body aches, flushed skin, swelling of face, diarrhea |
| 59 | 2021-02-14 | nausea, vomiting |
Naseau and vomiting commencing the following day and continuing for 24 hours; Naseau and vomiting co...
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Naseau and vomiting commencing the following day and continuing for 24 hours; Naseau and vomiting commencing the following day and continuing for 24 hours; Redness and swelling and acute pain at site of injection Aches; Redness and swelling and acute pain at site of injection Aches; Redness and swelling and acute pain at site of injection Aches; Pains in arm radiating in back and shoulder; Pains in arm radiating in back and shoulder; Pains in arm radiating in back and shoulder; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at 16:30 at single dose in Right arm for covid-19 immunisation. Patient was not pregnant.Medical history included allergies to cefalexin (KEFLEX), codeine and sulfa.Concomitant medication included escitalopram oxalate and omeprazole (PRILOSEC) . Patient experienced naseau and vomiting commencing on 28Jan2021 at 10:00 and continuing for 24 hours. On 28Jan2021 at 10:00 patient also had redness and swelling and acute pain at site of injection, aches and pains in arm radiating in back and shoulder.No treatment given. Final outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 59 | 2021-02-21 | difficulty swallowing |
"During monitoring period, pt experienced throat itching and slight difficulty swallowing. VS: 145/7...
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"During monitoring period, pt experienced throat itching and slight difficulty swallowing. VS: 145/70 given Benadryl 25mg by mouth @1400 by onsite provider. Patient was transferred to: home after additional monitoring and relief of symptoms, pt was given ER precautions
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| 59 | 2021-02-21 | vomiting | Fainted on 2/11/2021, bowel incontinence, and vomiting |
| 59 | 2021-02-21 | difficulty swallowing |
Two days after I got mouth sores that hurt, inside front lip and on tongue (I believe it was two or ...
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Two days after I got mouth sores that hurt, inside front lip and on tongue (I believe it was two or three sores, and they lasted about 5 or 6 days.) I share this because I got my second dose 2/17/21 batch EL9266 in left arm and again two days out got sores on my lip and tongue (total of 2 sores that hurt). The one on my tongue has made it hard to swallow, because it is far back on my tongue. I have used a peroxide product to lesson the pain. I am 5 days out from my second vaccine, and the sores are not getting worse and I hope they lesson and go away as the first batch did after about 6 days.
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| 59 | 2021-02-22 | nausea |
1. Throat closed up, could not breathe 2. Coughing 3. Nausea Treated with: EpiPen x2 Oxygen Nebuliz...
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1. Throat closed up, could not breathe 2. Coughing 3. Nausea Treated with: EpiPen x2 Oxygen Nebulizer Treatment
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| 59 | 2021-02-22 | decreased appetite | Chills, fatigue, body aches, no appetite Treated with Advil |
| 59 | 2021-02-23 | nausea | Nausea, Fever 100.0, body aches, chills, headache, fatigue |
| 59 | 2021-02-23 | nausea, vomiting | nausea, vomiting, hoarse throat, diaphoresis |
| 59 | 2021-02-24 | nausea |
injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swe...
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injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, nausea, feeling unwell, numbness and tingling in left hand thumb and pointer finger
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| 59 | 2021-02-25 | nausea, vomiting |
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to the emergency department two days after r...
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Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to the emergency department two days after receiving second dose of vaccine with persistent nausea and vomiting. Symptoms started the evening of the day the vaccine was administered. Vital signs within normal ranges. Patient observed in emergency department, adminstered intravenous fluids, diphenhydramine, and ondansetron which improved symptoms, and discharged to home stable.
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| 59 | 2021-02-27 | nausea | Body aches, temperatures to 101.8 F, chills, nausea. Lasted 30 hours |
| 59 | 2021-02-28 | vomiting, nausea |
Onset of severe nausea, emesis, and bloody diarrhea, requiring hospitalization for 8 days, infusion ...
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Onset of severe nausea, emesis, and bloody diarrhea, requiring hospitalization for 8 days, infusion care for 4 days after discharge due to hypokalemia, and resulting in diagnosis L ischemic colitis and hypokalemia.
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| 59 | 2021-02-28 | nausea |
nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest o...
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nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest of the body; arm swelling and pain; arm swelling and pain / pain was more severe in the arm; This is a spontaneous report from a contactable health professional, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9263,), via an unspecified route of administration on 26Jan2021 12:00 (at the age of 59-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included penicillin allergy, congenital heart defect. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) on 05Jan2021 at 16:00 (at the age of 59-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 27Jan2021 at 00:00 (on the 2nd day), the patient experienced arm swelling and pain. On 28Jan2021 (the 3rd day), the patient was nauseated, and the pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell. The events resulted in a doctor or other healthcare professional visit. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of arm swelling and pain, nauseated, pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell was not resolved.
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| 59 | 2021-03-01 | decreased appetite |
racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break;...
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racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break; joints and bones felt like they were going to break; no appetite; weakness, unable to get up out of bed; unable to get up out of bed; patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 09Feb2021 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sjogrens disease/syndrome (immune disease), sulfa allergies. The patient's concomitant medications included several medications daily. The patient previously took morphine and experienced allergies and made her sick. Historical vaccine included first dose of BNT162B2, lot number EJ 1686 on 15Jan2021 for Covid-19 immunization. The patient has no Covid prior vaccination. On 09Feb2021 11:00 am (also reported as started 12 hours after 2nd shot), she experienced fever 103, hard chills, racing heart, headache, joints and bones felt like they were going to break, no appetite, weakness, unable to get up out of bed. The patient informed that the hardest time and highest fever was 11 PM to 6 AM Tue/Wed. The chills were severe, felt like her spine would snap into. The patient was still sick Wed (10Feb2021), the fever was not as high 101 to 102. The patient informed that what was scary was heart racing for hours that first night. The patient thought she was going to die. The patient informed that she didn't have heart problems, but she has Sjogrens, an immune disease. The patient informed that the fever was finally back to normal on Thursday (11Feb2021) afternoon after getting shot Tuesday noon. The patient informed that it's Sunday (14Feb2021) and she was still tired and has headache. The patient informed that it has to be something to do with Sjogrens. The patient informed that her rheumatologist said nobody so far had the kind of fever/reactions she had. The patient has not Covid tested post vaccination. The patient has explicit consent. The patient did not received treatment due to the events. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "racing heart" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 59 | 2021-03-04 | diarrhea | Muscle aches and pains Fever mild Diarrhea prolonged 36 hours |
| 59 | 2021-03-04 | nausea |
Nausea, shortness of breath, lightheaded, itching LUA by injection site. BP 168/87 (pulse 69), 97% O...
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Nausea, shortness of breath, lightheaded, itching LUA by injection site. BP 168/87 (pulse 69), 97% O2 sat. Final BP 146/74 (pulse 63), 97% O2 sat.
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| 59 | 2021-03-04 | nausea | Tingling in Hands and Feet Blood Pressure Spike Nausea Cramping Dizziness / Lightheaded |
| 59 | 2021-03-17 | nausea |
headache; not feeling well; nausea; had a temperature of 100.4 and 100.2; weak and tired; weak and t...
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headache; not feeling well; nausea; had a temperature of 100.4 and 100.2; weak and tired; weak and tired; sinuses became very dry; This is a spontaneous report from a Pfizer-sponsored program, COVAX Support. A contactable consumer (patient) reported that a 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EM9809, expiry: 30Jun2021), via an unspecified route of administration on the left arm on 08Feb2021 at 16:45 (at the age of 59years) at 0.3 mL, single because she didn't want to get the virus and wants to get the world back to normal. Medical history included obese, prophylaxis (reported as she takes as extra precaution during winter) and abdominal discomfort (reported as stomach). Concomitant medications included cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, sodium ascorbate, thiamine mononitrate (ONE A DAY), montelukast sodium (SINGULAIR), lansoprazole for stomach, sucralfate, piroxicam (ZICAM) for she takes as extra precaution during winter, calcium and bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). Historical vaccine included flu shot and experienced arm sore and bed for the weekend (first time she got the flu shot she was in bed. It was kind of the same thing. Everyone said with the first vaccine it would make her arm sore. She was in bed for the weekend. She has had the flu shot five times in her lifetime. Subsequent flu shots she has been fine with. She doesn't have NDC, lot, and expiry for flu shot as it was at least 27 or 28 years ago). She received Pfizer COVID19 vaccine on Monday 08Feb2021 and her "sinuses became very dry" (in Feb2021). The patient experienced not feeling well, headache, nausea, temperature of 100.4 and 100.2 on 09Feb2021. During the night probably early on the ninth (09Feb2021) she got a headache, was not feeling well, and had nausea. When she got out of bed she had a temperature of 100.4 and 100.2. She thought that was a regular reaction to the vaccine. She didn't go to work. She felt weak and tired. She was told that was not usual for first but was for the second. She had slight headache the next day. She had a light headache for a few days. On Tuesday when she had the fever, she took paracetamol (TYLENOL, extra strength) and it wasn't getting rid of the headache. The fever came down a little. She wouldn't call what she had a big fever. She took ibuprofen (ADVIL, regular strength) later in the day. She normally doesn't take ibuprofen, but she did because she needed relief and paracetamol wasn't doing it. Since Wednesday, she might have taken one or two paracetamol a day. Once her sinuses started to dry out she started taking paracetamol. On Friday night her sinuses felt very dry and she was thinking it was all from the vaccine. She had a three day weekend. On Monday, she couldn't go back to work because she was nasally. Her symptoms began on 11Feb2021 and the health department had her quarantining for 10 days. The doctor said she should get tested and she was she then tested positive for COVID-19 on 12Feb2021. Apparently she picked it up coincidently. She couldn't figure where she picked up COVID. She tested positive. There was nothing concrete on when she can go back to get second COVID vaccine. She knows she couldn't be sick and symptomatic. She has to follow quarantine. The second appointment was on 01Mar. The patient asked if there was any guidance regarding when could she get the next dose and if she could return to work on 23Feb2021. Also asked if how long she could go without losing the efficacy of the first dose. She felt better today. She took the COVID test on Monday 15Feb2021. It was the PCR test. The results came in an email at 05:00 on 16Feb2021. The patient has been isolating in her bedroom. Her daughter was home. Her husband's company paid for him to stay in a hotel. She has felt good today and got on the treadmill. Usually she was a very active person. The facility was a state-run vaccine site. The patient had no previous immunization with the Pfizer vaccine, no additional vaccines administered on same date of the Pfizer suspect and no prior vaccinations within 4 weeks. The outcome of the events was unknown.
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| 59 | 2021-03-18 | diarrhea |
Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and un...
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Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and under arm on the side where got the shot swelled up; hurt quite badly; huge swollen lymph nodes; Body ache; Could barely walk; could walk to shuffle my feet; joints stiff; Horrible headaches; Diarrhea; I was dizzy and foggy; Night I break out into a horrible sweat in night like I have to change my pajamas twice; I am like wet; Arm sore/My arm was just little bit sore; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot Number: EN6202) (at the age of 59) as a single dose, for covid-19 immunisation. Medical history included an unspecified heart condition and a flu shot un an unspecified date. Concomitant medications included levothyroxine sodium (SYNTHROID) and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE). The patient stated, "I am calling about the side effects I had from my Covid shot vaccine. I am concerned about getting the second one because my reaction was so big. I got it on Saturday, this past Saturday about 12:45 I think 12:30 and I did fine, the shot didn't hurt at all. That night I was a little bit tired but that's it. My arm was just little bit sore. The next day I got up, I still felt good I went to work for 2 hours and then about 12 o'clock it hit me all at once. This Sunday I ran anywhere from a 103 to 104.6 fever and that was me taking Tylenol and I took Tylenol every 4 hour because my fever was still high. The glands in my neck and the glands under my arm on the side where I got the shot swelled up, they are still swollen. My whole body ached. I had Covid fairly bad I got pneumonia with it all for "two weeks" (not clarified) but my fever was not as high as got with the shot, the vaccine like I could barely walk after the vaccine because my joints were so stiff only way I could walk was to shuffle my feet, it was horrible. I had a fever yesterday all day but it was only in the 102.3 and 4, it never went back to 103. Glands in my arm and my neck hurt quite badly. My arm where I got it, it wasn't swollen but I get the same reaction when I get a Flu shot (unspecified shot) so that's not a big deal. I got horrible headaches. I had diarrhea all day Sunday and yesterday and so this morning my fever is only right around 101 like 101.1, 101.2, I am still super tired and also yesterday and day before I was dizzy and foggy. I still have a slight fever today. My lymph nodes are still swollen, my neck and under my arm, my arm where I got the shot is still swollen and sore but I can tolerate that. My joints are stiff a little bit but not nearly as bad as they were, so I don't know if I should get the second shot, everyone says the second shot is worst like all those heart palpitations start with it as well." One of my other symptom is at night I break out into a horrible sweat like I have to change my pajamas twice. It was last night and the night before. I am like really wet." The outcome of the events was not reported.
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| 59 | 2021-03-21 | abdominal pain | NA CAD, Chronic Abd pain with Opioid treatment - Chronic Pancreatitis |
| 59 | 2021-03-22 | vomiting |
Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM...
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Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM I started to get very red and my face was swollen then I started to have a difficultly in breathing then I felt dizzy and I had a high fever and I started vomiting. and my blood pressure was very high. Then I called 911 and I was transferred to the Emergency hospital.
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| 59 | 2021-03-28 | abdominal pain, abdominal pain upper |
Abdominal pain; Adrenal nodule; Calculus of gallbladder without cholecystitis without obstruction; H...
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Abdominal pain; Adrenal nodule; Calculus of gallbladder without cholecystitis without obstruction; Hepatomegaly; Right upper quadrant abdominal pain
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| 59 | 2021-03-28 | abdominal pain upper, nausea, abdominal discomfort |
Covid exposure on 3/3/2021. 3/9/2021 received first Pfizer vac. Within an hour was nauseated wit...
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Covid exposure on 3/3/2021. 3/9/2021 received first Pfizer vac. Within an hour was nauseated with pressure pain across the top of her stomach "under her ribs" and nausea. 3/10/2021 dev fever, weakness, and cough. Covid test 3/12/2021 neg. Eval in walk in clinic. Diag allergies. Rx oral steroid and Amoxicillin. A couple of days later, symptoms still continued. Eval in her physician's office 3/18/2021. Given steroid injection and antibiotic changed to Azithromycin. 3/19/2021 felt worse with pain/pressure under ribs and upper abd. eval in ER. O2 sat 87 improved to 93 with oxygen. Labs, chest xray, and CT scan obtained. Covid test neg. Admitted to hosp with diag of bilat pneumonia. Discharged on 3/22/2921 with steroids to take over next 5 days. She continues to have mild cough and pressure under her lower ribs. F/u appt scheduled with her physician. Was advised by her physician her pneumonia might be a reaction to the vaccine.
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| 59 | 2021-03-29 | nausea |
immediately following my left arm got a hot sensation, my hand went numb, and my fingers tingled. 1...
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immediately following my left arm got a hot sensation, my hand went numb, and my fingers tingled. 1 hour later I was nauseated and I had flu like symptoms, body aches, chills and a horrific headache. By 4th hour I needed to go to bed.
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| 59 | 2021-03-30 | difficulty swallowing |
Went to ER at 10 pm on 03/24/21 with red bumps on feet and legs with difficulty swallowing. Blood d...
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Went to ER at 10 pm on 03/24/21 with red bumps on feet and legs with difficulty swallowing. Blood draw showed platelet count <3,000 and transferred to Hospital ICU at 4:30 am on Thursday, 03/25/21. Diagnosed with ITP at Hospital on 03/25/21. Received two (2) bags of donor platelets, steroids, and IVIG Treatment on 03/25/21 and 03/26/21. Following treatment, platelet count rose to 48,000 on 03/26/21 and 03/27/21. Discharged from hospital on 03/27/21 with follow-up with hematologist scheduled for 04/02/21. Platelet count on recent blood draw on 03/30/21 showed platelet count at 148,000 with continued treatment using steroids only.
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| 59 | 2021-04-01 | decreased appetite |
Fainted; Body chills; fever; body aches; Loss of appetite; Weakness; Sleepiness; This is a spontaneo...
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Fainted; Body chills; fever; body aches; Loss of appetite; Weakness; Sleepiness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, in the left arm on 19Mar2021 at 21:00 as a single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date to an unknown date, prior to vaccination. The patient had a nasal swab test for COVID on 18Mar2021 with a result of negative. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccines in four weeks prior to the COVID vaccine. The patient experienced body chills, fever, body aches, loss of appetite, weakness, sleepiness and fainted on 20Mar2021 at 01:00. The patient did not receive treatment for the events. The outcome of the events was recovering. Information on batch/lot number was requested.
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| 59 | 2021-04-05 | abdominal pain upper, appendicitis, nausea |
approx 36 hours after first pfizer shot i developed stomach pain, sweating, nausea, and then chills....
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approx 36 hours after first pfizer shot i developed stomach pain, sweating, nausea, and then chills...pain continued for the next 4 days continue to get worse...sunday march 28 was admitted to hospital with acute appendicitis...
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| 59 | 2021-04-06 | nausea, decreased appetite, abdominal pain upper |
O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen; inflammation in the low...
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O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen; inflammation in the lower lungs that was rubbing on her diaphragm; Pneumonia; Cough/bad cough/dry cough; Stomach pain/top part of her stomach would hurt/stomach was hurting right at the bottom of her rib cage; gastroenteritis; short of breath; she wasn't breathing deep; feels like she doesn't have any energy; feeling bad; nauseated/felt sick to stomach; ate about half of her breakfast, this lasted for several days, she wouldn't eat much; This is a spontaneous report from a contactable consumer (patient's husband) via Pfizer. This consumer reported similar event for two patients. This is the first of two reports. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206, expiry date: unknown), via an unspecified route of administration, on 09Mar2021, as single dose, for COVID-19 immunisation. Medical history included exposure to SARS-COV-2 on 02Mar2021 (reported as "daughter tested positive for COVID on 02Mar2021, patient had been around their daughter and their daughter's husband, they went out to eat with them on the night of 02Mar2021"). Concomitant medication included esomeprazole sodium (NEXIUM) taken for an unspecified indication, start and stop date were not reported. On 09Mar2021, the patient received her first shot. About 20 minutes after she took the shot, she started feeling bad and became nauseated/felt sick to stomach. On 09Mar2021, the top part of her stomach would hurt, and she started developing a cough. On 11Mar2021, the patient felt like she doesn't have any energy. The coughing went pretty bad so on 12Mar2021, the patient took a COVID-19 PCR test and it came back negative. The patient kept having a bad cough so then they went to the doctor where they put the patient on prednisone 20 mg and amoxicillin 875 mg on 12Mar2021. On 16Mar2021, the patient went to the family doctor and the doctor put the patient on azithromycin and gave her a steroid shot. Then the patient kept coughing and her stomach was hurting right at the bottom of her rib cage. The patient was never getting better or anything. So, on 18Mar2021, the patient had COVID-19 Virus test where they swabbed her nose and the test came back negative. The patient was taken to the hospital on 19Mar2021 at 11:30 where they did an x-ray of the patient's lungs and her O2 level was 82-86 sitting in the bed (also reported as 84-86 so she was put on oxygen), performed CT scan of her lungs and it looked like there was inflammation in the lower lungs that was rubbing on her diaphragm, and performed Chest CT which determined pneumonia. That night they did another COVID-19 virus test where they went really deep and it came back negative. The patient was admitted to the hospital on the night of 19Mar2021. The patient was given IV ceftriaxone, IV azithromycin, azithromycin (also reported as Zythromax), one breathing treatment, and they said they may have to send the patient home with some oxygen. It was also reported that on 19Mar2021, the patient did really good with coughing, she didn't cough that much. The patient had a dry cough that wasn't productive at all. The patient acted kind of short of breath because she wasn't breathing deep because of the pain in the top part of her stomach, but the reporter doesn't believe it was true shortness of breath. When the patient got out of the hospital on 22Mar2021, she didn't need to come home with the oxygen. The patient's oxygen level is running pretty good at the time of the report, in the lower 90s (Mar2021). The patient was on Decadron 6 mg for 5 days and she's doing pretty good, she still has a little bit of a cough. It was also reported that in Mar2021, the patient only ate about half of her breakfast, this lasted for several days, she wouldn't eat much. The patient pretty much recovered from the nausea. When she ate, it felt like everything would make it to her stomach and just sit there. The emergency room doctor said it could be from gastroenteritis, also they gave the patient several rounds of Protonix. The patient usually takes Nexium every night. The doctor felt that this event could very well be from the vaccine. The reporter asked if the patient could get the second shot on 30Mar2021. The patient was recovering from "Cough/bad cough/dry cough", "Stomach pain/top part of her stomach would hurt/stomach was hurting right at the bottom of her rib cage", and "O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen"; has recovered from "nauseated/felt sick to stomach" on an unspecified date. The outcome of the events "inflammation in the lower lungs that was rubbing on her diaphragm", pneumonia, "feeling bad", "ate about half of her breakfast, this lasted for several days, she wouldn't eat much", "feels like she doesn't have any energy", "gastroenteritis", "short of breath" and "she wasn't breathing deep" was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329963 Same reporter, drug and event; different patient
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| 59 | 2021-04-06 | nausea |
head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then fe...
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head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb, numbness to both hands; started feeling sweaty; shortness of breath; light headed; nausea; blood pressure drop to 40; The initial was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 23Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 59-years-old via an unspecified route of administration, administered in arm left on 05Jan2021 (Batch/Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included atrial fibrillation, thyroid problem, hearing problem from an unknown date and unknown if ongoing, Stroke like paralysis from 2014 to an unknown date, gallbladder removal in 2018. Concomitant medications included sotalol, taken for atrial fibrillation from Dec2019 and ongoing; levothyroxine taken for thyroid disorder from 2017 and ongoing; cyanocobalamin (B-12) taken for an unspecified indication from 2014 and ongoing; aspirin [acetylsalicylic acid], taken for an unspecified indication from 2014 and ongoing. The patient experienced 3-5 minutes after the first dose on 05Jan2021, started feeling sweaty, shortness of breath, light headed, nausea, numbness to both hands. Next day 06Jan2021, wake up with numbness to left hands, head aches, chills, weird feeling in head (back left side of head). This went on for about 2 weeks lasted 1 month got better as days went day. It was also reported that she experienced that her left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb for period of 2 weeks. Her blood pressure drop to 40 on 05Jan2021. The patient underwent lab tests and procedures which included blood pressure measurement: drop to 40 on 05Jan2021, sars-cov-2 antibody test: 0 (came out 0 antibodies on my blood work had never been expose to anyone with Covid 19) on 24Nov2019, sars-cov-2 test: negative on 08Jan2021. The patient also reported that on 05Jan2021, she received the dose and had a reaction to it, but that same day her mother was taken to the hospital because she wasn't breathing well and she came out positive to Covid, she passed away 14 days after the patient took a test on Covid 08Jan2021 tested negative. She don't know if it was soon to be tested but other family member tested positive. The patient did not receive treatment for the events and was hospitalized due to the events. The patient did not recover from nausea, headache, chills while the outcome of the other events was unknown.
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| 59 | 2021-04-07 | abdominal pain upper |
passed out; bad stomach ache; Tired; not normal; This is a spontaneous report from a contactable con...
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passed out; bad stomach ache; Tired; not normal; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), lot no. EN60207, via an unspecified route of administration (left arm) on 19Mar2021 10:15 at a single dose for COVID-19 immunisation. The patient had no relevant medical history. She had no known allergies. No covid prior vaccination. Concomitant medications included levothyroxine, simvastatin, calcium, and multivimi (as reported). Historical vaccine included first dose of BNT162B2 (brand=Pfizer, lot no EN6203) on 26Feb2021 10:15 AM, left arm at age of 59 years. No other vaccine in four weeks. On 20Mar2021, the patient got up to go to bathroom at 4:00am Saturday and passed out. Bad stomach ache Saturday (20Mar2021), Sunday (21Mar2021). On Mar2021, tired and not normal til Thursday. No treatment for the events. No covid test post vaccination. The patient recovered from bad stomach ache on 21Mar2021 and from other events on Mar2021.
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| 59 | 2021-04-10 | appendicitis |
Six days after receiving the second vaccine . I developed acute appendicitis with peritonitis. I ha...
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Six days after receiving the second vaccine . I developed acute appendicitis with peritonitis. I had to have my appendix removed . Since my surgery I have two friends that each have a family member that also got appendicitis and had to have their appendix removed .
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| 59 | 2021-04-15 | nausea |
sore right arm, fever, fatigue, nausea lasted 4 days, unable to get out of bed or eat due to nausea,...
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sore right arm, fever, fatigue, nausea lasted 4 days, unable to get out of bed or eat due to nausea, which led to dehydration.
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| 59 | 2021-04-24 | abdominal pain upper |
Got violent shakes and chills; Got violent shakes and chills; Stomach pain; temperature suddenly got...
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Got violent shakes and chills; Got violent shakes and chills; Stomach pain; temperature suddenly got to 103.5; Blood Pressure was very high; flu like; 1st dose :20Mar2021; 2nd dose: 04Apr2021; 1st dose :20Mar2021; 2nd dose: 04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Apr2021 11:00 (Lot Number: EW0150) as single dose (at the age of 59-years-old) for covid-19 immunisation. Medical history included breast cancer, anxiety, depression, irritable bowel syndrome (IBS), Low Thyroid, arthritis. Patient had no known allergies. It was reported that patient received concomitant medications in two weeks prior to the vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration, administered in Arm Left (Lot number: ER2613) on 20Mar2021 12:00 PM (at the age of 59-years-old) for COVID-19 immunization. It was reported that patient received first dose on 20Mar2021 and second dose on 04Apr2021 (Inappropriate schedule). Patient stated that she had her second (2 nd) shot on 04Apr2021 (Sunday), was fine until 07Apr2021 (Wednesday). On 07Apr2021 at 15:00 she got violent shakes and chills, stomach pain, temperature suddenly got to 103.5. Patient went to Emergency room. Blood Pressure was very high. She was released and better on Friday but still flu like. They could find no reason for this and three doctors (Dr's) thought it was a reaction to the vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 3 days. She was treated with intravenous (IV's), Antibiotics, cat scan and X-ray, results unknown. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 07Apr2021. She was recovering from the events, at the time of the report.
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| 59 | 2021-04-24 | appendicitis |
appendicitis; sweating; 1/2 later developed chills; This is a spontaneous report from a contactable ...
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appendicitis; sweating; 1/2 later developed chills; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 22Mar2021 14:30 (Lot Number: er8727; expiration date: 31Jul21) as a single dose for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERDs), migraine and unspecified allergies. The patient was not diagnosed with Covid prior vaccination. Concomitant medications included unspecified medication. The patient did not receive other vaccine in four weeks. On 24Mar2021 (36 hours after the shot), the patient developed stomach pains, sweating and nausea, 1/2 later (unspecified) developed chills. The pain and nausea continued for 4 days admitted to hospital (unspecified date) and being treated for appendicitis. The patient was hospitalized for 4 days. The treatment included antibiotics with surgery pending. The patient has not been Covid tested post vaccination. The patient inquired if she should get the second dose. The patient mentioned that her physician stated that you can't get the vaccine for 90 days after having the Covid virus. She inquired about the efficacy after having 1 dose of the vaccine. She further reported that she received her first Covid vaccine dose on 22Mar2021 and on 24Mar2021 she began having stomach pains and later diagnosed with appendicitis. She added that she has been trying to do her own investigation on if she should receive the second dose as her HCP's have been unable to provide guidance. She mentioned that she has been trying to determine if it will be safe to get the second dose given that she experienced appendicitis after the first dose. The events resulted in emergency room visit. The outcome of the event was not recovered.
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| 59 | 2021-04-26 | nausea, vomiting |
to make sure there is no pulmonary embolism; Shaking legs and arms; Lightheaded; PVCs (Ventricular p...
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to make sure there is no pulmonary embolism; Shaking legs and arms; Lightheaded; PVCs (Ventricular premature beat); Large black bruise on left breast; 40 hrs fever; throwing up/vomiting; nausea 36 hours; intermittent breathing issues/sporadic breathing issues/difficulty breathing and hard to get a breath; She was weak; severe migraine; Headache; Brain fog; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of bnt162b2 (BNT162B2, lot number ER8727, expiration date: 31Jul2021), via an unspecified route of administration in arm left on 07Apr2021 12:00 as single dose for Covid-19 immunisation. Medical history included allergy ( macro Danton, sulfa). Patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medication included Nerontin. The patient reviously received flu vaccine and had normal things, previously received first dose of bnt162b2 (Lot Number: EN5318; Expiration Date: 31May2021) in arm left on 17Mar2021 16:00 and experienced acute lymphatic response, brain fog and arm started to hurt. The pateint was calling because her doctor, who she saw yesterday 14Apr2021, told her she should let Pfizer know what was going on. She had a reaction to the Pfizer Covid19 Vaccine. she was now having PVCs. The patient added that all of the events started with a fever, and throwing up. She had a fever and threw up for 36 hours. She had to contact her physician to get medication and to stop vomiting and the nausea and everything. During that time, she was sick. She was having intermittent breathing issues which she did not think she felt too much of until after the other sickness was over. She was weak, like people get after they are sick, and had bizarre shaking legs and arms which was strange. She added that she had breathing issues and difficulty breathing and hard to get a breath. That was what she was dealing with. Treatment: caller took Pedialyte and all the proper things to get back into better shape. The breathing issue still remained. The doctor called in a rescue inhaler. She kept going downhill so he called in a rescue inhaler. Large black bruise on left breast after second vaccine: Caller added that this one will not be believed but on Monday, she woke up and got dressed again and was just weak and had breathing issues but was just doing work on the laptop. She did not fall, she did not run into anything. In the evening, she went to take a bath and saw that when she took her clothes off there was a large black bruise on her left breast, it was probably 2 inches in diameter. It is very large, but does not hurt like a bruise. She checked the rest of her body for blood issues and only saw a couple normal looking bruises. She contacted her doctor, and they questioned her thoroughly on her bruising and activity. This was on Monday. Tuesday, she still felt the same headache, weak, and breathing issues. PVCs (Ventricular premature beat) after second vaccine: Yesterday, 14Apr2021, she started declining and the doctor wanted to see her. Caller stated the doctor heard PVCs in her heart. Caller asked clarification of PVC abbreviation and does not provide. She never had heart issues ever. The doctor did blood work and a chest x-ray, and saw the bruise and was worried about her blood. Caller added that even though these are not listed as side effects of the vaccine, she was worried. Her doctor sent her to a facility for chest x-rays to make sure there is no pulmonary embolism. Caller confirmed this was on 14Apr2021. She has not yet heard back. PVCs after second vaccine: Caller added the doctor said her lungs sounded good but wanted to see what was going on to see how her breathing was because there was difficulty. The doctor wanted to cover bases and check. Today, caller can tell her heart is still not in correct rhythm and that it is in continued PVCs. She still had the same breathing issues, limbs were weak, she was shaky, and she is lightheaded. She was hoping to wake up today and feel better. Fever after second vaccine: started 3am 08Apr2021. She had a fever and was throwing up at this time. Throwing up and nausea after second vaccine: caller add that throwing up and vomiting with nausea occurred at 3 am, all of this occurred 08APR2021. The vomiting lasted 36 hours, and it ended when she took medication. The fever lasted 40 hours. Even after the medication worked for her fever, she had nausea. Around Friday was when it went away. Intermittent breathing issues after second vaccine: caller adds it started with throwing up and fever, but she did not think a lot about this or know when it started because she was dealing with the fever and vomiting. It continued, and it has not subsided or ended. As a matter of fact, there are 2 or 3 times it has gotten bad which is why she was given an inhaler. Treatments: caller took a Phenergan suppository, which she adds is the best medicine in the World for nausea and beats Zofran. She had used two or three doses and it did work. She used a rescue inhaler, Albuterol Sulfate HFA. She took Tylenol for fever. She is also now taking an aspirin daily because of the blood issues. No additional information regarding the products. Weak after second vaccine: caller adds that this started at the same time, she was over the nausea and noticed this. It felt different than what it feels like with the flu. This is still going on, she did not think too much about it but it has persisted. Sometimes there is a little bit of shaking but that is intermittent. Caller states she can not put it into words. Bizarre shaking legs and arms after second vaccine: this goes with the weakness, she is continually weak but she has a shaky feeling that will come every now and then and is random. Large black bruise on left breast after second vaccine: Monday this started, 12APR2021 and it is still there but it is the same. It has not been sore like a bruise but it is black and large. The physician has seen it now and it is bizarre and scary. It is the left breast on the outside. Headache after second vaccine: started probably an hour after the vaccine, pretty quick. There were degrees to this headache because it was an actual migraine for a good 48 hours and even after the fever was gone it was terrible. It started out just a mild headache and then was very severe for a couple of days. Then, after that it was just there but not as severe. PVCs after second vaccine: caller adds that she went to the doctor yesterday 14APR2021 and she can tell every now and again that she is having these but there is nothing she can do about it. Caller adds this is everything new she can think of, but some of it is foggy, she thinks this is the main information. Brain fog after first and second vaccine: Caller then states, by the way, after both vaccines within 2 or 3 minutes of having them her head started feeling foggy and weird. Investigations: caller has not received any results yet. She did get an EKG, Chest XRAY, blood work, and the doctor also rattled off a bunch of things the doctor was going to check. These all were on 14Apr2021 and she is waiting on results. Caller confirms the physician told her she had PVCs while listening to caller's heart. Did any AE require a visit to: Physician office? 15Apr2021 she was in contact with her physician, and the whole week they were on the phone. Yesterday 14Apr2021 the physician wanted to see her. The doctor figured out something was going on with her heart so thankfully the doctor wanted to see her. It was discussed if caller should go to the ER but caller did everything she could not to go because that is the last place she wants to go. Emergency Room: no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of fever, vomiting, nausea was recovered, intermittent breathing issues, shaking legs and arms, weak, severe migraine, headache was not recovered, for other events was unknown. No follow-up attempts are needed. No further information is expected.
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| 59 | 2021-04-28 | diarrhea, nausea |
Lost consciousness; dizzy like she was about to faint; twitching and shaking; eyes went to one side;...
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Lost consciousness; dizzy like she was about to faint; twitching and shaking; eyes went to one side; she was about to faint; seizure; Diarrhea; chills; head hurting; eyes hurting; Muscle soreness; joint pain; Nausea; temperature of 99.3; This is a spontaneous report from a contactable consumer (daughter of patient) and another consumer. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 16:21 (Lot Number: EW0164; Expiration Date: Aug2021) at vaccination age of 59 years old as single dose for covid-19 immunisation. Medical history included vertigo, antacid therapy. Concomitant medication included esomeprazole magnesium (NEXIUM 24HR) taken for antacid therapy from an unspecified start date and ongoing. No additional vaccines administered on same date of the Pfizer Suspect. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EP7533), on 23Mar2021 at 17:38 PM at age of 59 years old in the right arm as single dose for covid-19 immunisation and only had a little bit of muscle soreness on her right arm on 23Mar2021 after the first dose and it went away the day after (24Mar2021). The patient took Tetanus shot about two weeks before the first dose of the Pfizer COVID 19 vaccine. Then received the second dose on 13Apr2021 16:21PM in the left arm. After the second dose she had chills; her head was hurting; her eyes were hurting; she had muscle soreness; she had joint pain all yesterday 14Apr2021. Then this morning 15Apr2021, after taking a Tylenol and getting a shower she felt dizzy like she was about to faint. Her mother had vertigo but this was not like her usual vertigo. Her mother sat on the bed and started to have what looked like a seizure with twitching and shaking; then she lost consciousness. Her mother's eyes were open and they saw her mother's eyes twisted, went to one side, and she fell back on the bed. They called at 05:30 AM and the ambulance arrived quickly but by the time they arrived she had regained consciousness. They recommended she follow up with HCP. They called the doctor who advised her to rest, and make an appointment to see the doctor tomorrow. Reporter clarified her mother had the chills from 10:00 AM today (15Apr2021) and had them day with a lot of headache, eyes hurting goes along with the headache, and she had a temperature of 99.3. The chills and temperature resolved last night then the eyes hurting ended this morning (15Apr2021) with the headache. All of the other symptoms resolved yesterday (14Apr2021). She also had nausea that started yesterday (14Apr2021) and she started to have diarrhea once today (15Apr2021)and felt like it had stopped. The nausea was coming and going from time to time. The events did not require a visit to emergency room or physician office. The outcome of events chills, muscle soreness, joint pain, temperature of 99.3 was recovered on 14Apr2021. The outcome of events Lost consciousness, head hurting, eyes hurting, felt dizzy, twitching and shaking, eyes went to one side, Diarrhea was recovered on 15Apr2021. The outcome of event seizure, she was about to faint was unknown. The outcome of event nausea was recovering.
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| 59 | 2021-04-28 | diarrhea |
severe pain in lower left side.; diarrhea; diverticulitis; Had black liquid stool.; This is a sponta...
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severe pain in lower left side.; diarrhea; diverticulitis; Had black liquid stool.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 23Mar2021 07:15 as single dose for covid-19 immunization in a pharmacy. Medical history was reported as none. No known allergies. The patient was taking an unspecified antibiotic between 1-2 weeks. No other vaccinations were done in four weeks. The patient has not had COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. On 24Mar2021, 1 day after vaccination the patient had diarrhea. On 25Mar2021, 2 days after, the patient had severe pain in lower left side. The patient was diagnosed with diverticulitis on an unspecified date in Mar2021. The patient also reported black liquid stools in Mar2021. The patient ended up in the ER on an unspecified date and got a scan and was sent home with antibiotics as treatment. The patient was getting better but not yet 100%. The patient underwent lab tests and procedures which included scan: unknown results on an unspecified date. The outcome of the events was recovering.
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